FDA Warns Of Tendon-Rupturing Antibiotics

The FDA slapped a black box warning on a group of antibiotics known as fluoroquinolones for their link to tendonitis and tendon rupture in patients. Drugs in this group include Cipro, Levaquin, Avelox, Oscient, Factive, Proquin XR, Floxin Noroxin. Ruptures associated with the drug have included the achilles tendon, thumbs, shoulder, bicep and hand. Public interest group Public Citizen has been petitioned the FDA in 1996, 2005 and 2006 to add greater warnings to the drug. Only after Public Citizen sued the FDA for not responding to the petitions were the warnings added. One patient described what happened after he was hospitalized for an infection and treated with Cipro…

In December 2007, John (not his real name) was in hospital with an infection and he was given Cipro. “Shortly after starting treatment with Cipro, I felt a “popping” in my shoulders,” he says. “At the time, I could barely move my arms and since then I have suffered constant pain; I am only now starting to improve thanks to physical therapy.”

Any patient taking these drugs and experiencing tendon pain should immediately stop taking them, stop any exercise, and contact their doctor.

Antibiotics can harm tendons, FDA warns [Reuters]

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  1. superlayne says:

    That is some serious Saw stuff. To cure yourself you have to drink a bucket of tendon melting antibiotics or something.

    How does this happen, biologically, though?

  2. azntg says:

    Why do we always have to go to litigation (or show up on the Consumerist) before things are on their way of getting done right?

    One nice society we live in.

  3. Cerb says:

    I don’t really see what the big deal with having the “black box warning” is. We have been well aware of the effects of flouroquinolones on tendons for some time. It’s one of the classic possible side effects taught in medical school and the reason we really avoid using them in children. Luckily the side effect is quite rare and the safety profile is otherwise very good. I’ve yet to see a case of it (although we had a possible case in a geriatric patient with contracture of his hip).

  4. Juliekins says:

    Holy crap. Cipro is one of the few antibiotics I can take. I’m allergic to penicillin. Good thing when I’m on it I’ve been too sick to work out. It sounds like a nasty injury waiting to happen.

    I highly recommend not being allergic to penicillin. It’s an expensive pain in the ass. :P

  5. SOhp101 says:

    @Cerb: Unfortunately not everyone has gone to medical school =(.

    Plus you’d be surprised at the level of knowledge that doctors lack when it comes to prescriptions. Not that I’m pointing the finger, since it is quite an overwhelming area to try and keep up with.

  6. mir777 says:

    Crap! I am hurting right now (tendonitis) and wonder if it’s all the Cipro.

  7. Hongfiately says:

    @Cerb: Right. This isn’t news if you’ve read about what you are putting into your body. I follow a regular exercise regimen and so I have to be mindful of side-effects. Example: You don’t want to take something with photosensitivey as a side-effect and then go out and run in the heat of the day.

    Same thing applies with Cipro, which I was taking last fall. I read through the literature that came with my script and there was what I considered adequate warning about tendon damage so I throttled back on my running and weights for the 10 days I was on it.

    Always read through the information you get from the pharmacist. If you don’t get any stapled to your script or as a sticker on the label, ask for it. If you still don’t get any, get a new pharmacy. You can also go to a site like RxList and check it out there.

    [rxlist.com]

  8. nsv says:

    @Juliekins: I’m allergic to penicillin too, and there are lots of other antibiotics I can take. I usually end up with one of the macrolides like Erythromycin or Zithromax. Do you have other allergies to deal with?

  9. TechnoDestructo says:

    @azntg:

    See: every article about academic cheating.

  10. dinobuddy says:

    I just like saying Floxin Noroxin. It really rolls off the tongue. Just like the enormous tendon-rupturing pill it refers to!

  11. JennQPublic says:

    When my mother recently scraped her finger they gave her Cipro to prevent tetanus. Neither the doctor or the pharmacist told her this was a possible (however unlikely) side effect. I found out from the internet.

    She chose to take it anyway, and she was fine, but I still feel like she should have been told by a health professional, not the interwebs.

  12. huadpe says:

    I see this as potentially serious, and a very good reason for prescription drugs to be prescription based. Yes, it has potentially dangerous side effects, but those should be weighed against the cost of doing nothing, and a medical professional should decide what’s best. Not treating an infection can be far more dangerous than these side effects, and if cipro is the safest antibiotic that won’t cause an allergic reaction, then even if it might cause joint problems, it might be a good idea to prescribe it.

    I don’t see the fuss over a “black box” warning. Patients shouldn’t be picking up high-strength antibiotics off the shelf. And doctors should know the side effects of what they’re prescribing, and check a reference volume if they’re not sure. I don’t have a problem with my MD checking the Merck Manual to make sure I get the right dosage and info.

    I am not a doctor, and this is not medical advice.

  13. nsv says:

    @huadpe: I don’t have a problem with my doctor checking reference books. They’re human beings and can’t know everything. Unfortunately, they usually don’t check. Can’t turn over ten patients an hour if you’re wasting time looking things up, can you?

    The pharmacist would seem to be the next line of defense, but I’ve never gotten good information out of a pharmacist unless I had done my research and had good questions to ask. When the pharmacy tech snaps “Got any questions?” while looking past me at the next person in line, I would never (until now) have come up with “Will this medication cause my tendons to rupture?”

  14. scerwup says:

    That’s just disturbing

  15. katyggls says:

    I’ve taken Cipro and Levaquin and never ruptured anything (well except a few blood vessels when I saw the doctor’s bill). I think as huadpe says, when you weigh the small possibility of a rare side effect like this against doing nothing for an infection, these drugs don’t seem like such a bad idea.

  16. TheLemon says:

    I’ve personally had a terrible reaction to a quinolone (just one pill!) that sent me to the ER. It surprises me that more people aren’t aware of the risk. Ruptured tendons are only one of the possibilities with these drugs. They cross the blood-brain barrier.

    You may trust your doctors and your pharmacist, but any time you take a new med, you should first look it up online so you are more clear on the risks vs. benefits.

  17. evslin says:

    @dinobuddy: I was going to say, some of these medication names sound like characters in a cartoon or something.

    “Today I’m going to take over the city, and there’s nothing you can do to stop me, Avelox!”

    “Guys! We have to stop Floxin Noroxin before he destroys everything! Let’s get to headquarters right away!!”

  18. kable2 says:

    because the government is controled by big business and their lobbyists. When they give big dollars to a member, they will vote with their wallets. Thats why.

    @azntg:

  19. TheLemon says:

    Patient-reported stories about one of the quinolones (Levaquin) and its side-effects. It’s about time the FDA gave it a black box.

  20. TheLemon says:

    [www.askapatient.com]

    Oops, forgot the link.

  21. beavis88 says:

    @Juliekins: Meh, penicillin sucks anyway. Try being allergic to cephalosporins – the first thing doctors reach for to treat any sort of semi-serious infection is, you guessed it, a fluoroquinolone. Last time I took Levaquin the tendon-rupture thing was definitely noted as a possible side effect in the (long, long) drug information sheet.

  22. polyeaster says:

    This is concerning…last year I took Levaquin after a dog bite, and it was never mentioned. Besides the tendon-rupturing risk, the drug also makes many people have psychotic dreams:(

  23. d4ygl0down says:

    Last summer I contracted a nasty strain of strep throat, which after a round of antibiotics turned into a bronchitis. I went to urgent care, and they gave me Levaquin. After taking that round, it turned into a sinus infection. I went to my general physician (in Columbus Ohio, I recently moved to Cleveland), and told him what was going on (at this time I had been sick for almost a month). He prescribed another longer round of Levaquin. Fast forward a few weeks later and while I’m working my shoulder and back begin to hurt and my hand goes numb. I have been through over a month of physical therapy to cure this (and $500 out of my own pocket). If I had known this was a side effect I wouldn’t have taken it and demanded something else. No one told me this would happen!!!!

  24. Juliekins says:

    @nsv:
    I can take the ones you mentioned too. I think it was a bigger issue when I was a kid–more drugs have come out since then that aren’t penicillin derivatives.

    @beavis88:
    Yikes! That really knocks out a big range of drugs.

  25. alice_bunnie says:

    You know people there are side effects of every drug and you either read the monograph or ask the pharmacist. This is why when there was the big anthrax scare and everyone was screaming that they wanted Cipro available to every person everywhere we were being cautioned that Cipro was a very potent antibiotic with very strong side effects that they didn’t just give out to everyone for everything.

    I have taken Levaquin and had a nasty reaction to the sun. You might remember they had an article that mentioned it here a while back. I had read the warning, but you never know if it’s going to happen to you. And, I DO remember reading the monograph about sun sensitivity, but I didn’t know it’d be like that. And, I DO specifically remember tendon rupturing and I thought “WTF?”

  26. mjsager says:

    I’ve been dealing with a Reaction to Levaquin for 6 months now. It absolutely fucking sucks.

    I have the following:

    neuropathy, which is numbness / tingling all over my body
    Joint pain – at times I can barely walk
    Tendon problems
    Floaters

    Now you might think that this only affects me. Its cost my medical plan probably $5k so far.

    The other thing is that the doctors I encountered were absolutely clueless. So far as to absolutely deny the drug had anything to do with my ankle pain. Which if you read the side effects is listed as a serious side effect. It was only when I went to a major university hospital did anyone believe anything I was complaining about.

    If you google joint pain + cipro there are almost a million hits, and if you ask your doctor about it they will deny there is any connection.

    The worst part is that I should have never been given this drug. A much cheaper and safer drug was available ( $15 vs $800+ for a 60 day supply ).

  27. jkpwife says:

    My husband was taking the Cipro and his knee became tender and swollen and his gout in his big toe became so bad he could hardly walk.

  28. crazybutch says:

    @alice_bunnie: on the monograph they gave me for cipro, they say contact your doctor asap if you have tendon pain.they don’t say to stop taking it, they don’t say what it might mean…. they make it not seem like a big deal.

    this sucks. i’m taking the exact medicine in the picture right now. but i guess it might be better than me taking nothing. it’s just that i’m pretty sure it will hurt if my tendon snaps, so this has me on edge….

  29. Cerb says:

    Whoever said that there isn’t a drug without a side effect is spot on. It’s why you can’t just stroll into a pharmacy and ask for whatever you want. The safety profile of some drugs is downright scary – it’s not that they are bad drugs, it’s that they are drugs and drugs can have very nasty side effects in some people. I really don’t consider this side effect all that bad considering some other possible side effects of other drugs. When we decide to prescribe this, or any, drug it’s because we think the danger of not treating is much worse than the danger of treating. I will still use flouroquinolones, they are fantastic drugs for most people.
    Also, it should be noted as I see some people freaking out on here about knee pain, etc following abx use. The VAST VAST majority of tendon ruptures occur at the achilles tendon. And when it happens…you’ll know.

  30. Imaginary_Friend says:

    Check out what others think about a medication before you take it at askapatient:

    [www.askapatient.com]

    The reviews for Cipro are terrible:
    [www.askapatient.com]

  31. texasannie says:

    The list of drugs citd in the article is a list of brand names (and one manufacturer). Some of these can be given in generic form, so I’ve listed the generic names below. Also, Oscient is not a drug; it is the company that manufactures Factive. Floxin and Noroxin are two different drugs rather than being one dug with a wacky name. There should have been a comma in there.

    Cipro = ciprofloxacin
    Levaquin = levofloxacin
    Avelox = moxifloxacin
    Factive = gemifloxacin mesylate
    Proquin XR = ciprofloxacin hydrochloride
    Floxin = Ofloxacin
    Noroxin = Norfloxacin

    As others have said, most medications can have serious side effects, so it’s always important to monitor yourself for unusual side effects while taking a drug. These warnings are good because they let you know of specific problems to look out for, but they shouldn’t discourage most people from taking medications as prescribed. Tendon rupture sucks if it happens, but not treating a serious infection (which is what these drugs treat) can be much worse.

  32. mjsager says:

    @Cerb:

    The problem is not that these drugs have side effects. Its not that these side effects are potentially dangerous.

    The problem is that people are experiencing side effects at a higher than advertised rate. That doctors are using these serious antibiotics for things like, a sinus infection, which for the most part is pretty ridiculous as there are much much safer drugs around for those sorts of things.

    The doctors underestimate the level of harm that can be caused because they haven’t been warned.

    I’m on the yahoo group of people who have had these reactions, and a majority of these people should have never been prescribed these drugs. Seriously, Cipro or Levaquin for a sinus infection? Unless its a resistant strain its like using a nuclear missile when you really just need a fly trap.

    There are a couple thousand people on that list, most everyone with a pretty serious reaction.

    I’ve been in excruciating pain for 6 months because of this drug and the doctors I talked to expressed the same attitude as you except at the university hospital.

  33. LuckyEmmie says:

    A neighbor of mine experienced a double achilles rupture after being on one of these antibiotics; he wasn’t doing anything strenuous, just walking along… It’s a scary thought, but all meds have side effects, and it’s not really practical for a doctor to pull out a PDR and read it to you every time they prescribe you a med. That’s why you have the option of consulting with a pharmacist, and why they give you those detailed inserts with your prescription.

    I was on Cipro just last week after a nasty reaction to Macrobid, and I made sure to read over the insert. The risk of tendon rupture was plainly stated. I’m not sure what more there is to be done, other than having a warning on the packaging.

    In response to @crazybutch: , I would think that a warning to contact a doctor ASAP for a specific reaction is an indication that the reaction is a big deal.

  34. SadSam says:

    Ask your doctor for the PDR print out for any new drug and ask them to review it with you. Make sure your doctor knows what other drugs you take (prescription, over the counter and vitamins). Most likely the doctor will cover the most common side effects (headaches, upset tummy, things like that) but the dicussion may lead to a risk factor that you were not aware of. All drugs have side effects, the doctor should be picking the best drug for the illness while also balancing the side effects.

  35. Phexerian says:

    This side effect is one of the more rare ones with fluoroquinolones. It has a rate of 3% vs the comparator group with a 95% confidence interval in patients under 17 years old. With adult patients it is less than 1%. Elderly patients I did not see any data on, however, my search was rather brief.

    Physicians and Pharmacists don’t tell you about every side effect of the drug. If we did, we would be sitting there rattling off everything on a list for a few minutes. We generally only tell you about the most common side effects. This is why a drug insert comes with your medication the first time you get it. If it doesn’t, you need to get it from your pharmacy or switch pharmacies.

    It’s kinda like myopathy with statins (Lipitor or Zocor). It has a rate of 1 in 10,000 but people get really uppity about it. Myopathy can be really bad, but it can also be just a slight case.

    Perhaps the FDA is putting this black box warning on it because they think they drug company skewed the data. Perhaps it happens more than is reported in the clinical trials or post market studies. It was quite a while that the FDA took to respond to their complaint. However, one should realize that they are underfunded and understaffed. This is not a defense for them, just a reason why it could have taken so long. However, this is all speculation on my part.

    Overall, Fluoroquinolones are good antibiotics. They are first line generally for people who are allergic to penecillins and cephalosporins, and are also first line for many UTI and respiratory infections because they work well.

    -Phex
    -3rd Year PharmD / MBA Candidate

  36. mjsager says:

    If someone followed the problems with this antibiotic, you’d be surprised how far it went.

    For example, most doctors receive only minimal payment for an office visit, so there is a pressure to see as many patients as possible and spend as little time with each patient. There is little time to discuss side effects. Many only make money on the tests they order.

    Chinese catfish farmers use these antibiotics because the conditions there are pretty bad in the farms. The use of this antibiotic puts our catfish farmers at a disadvantage. Its illegal to use, but the FDA doesn’t do any testing.

    There is a financial incentive for drug companies to minimally discloses risks so their drug will be used during the patent window. Vioxx, etc etc etc etc.

    Farmed salmon outside of the U.S. makes extensive use of these antibiotics, which weakens their effectiveness and puts our fish farming operations in at a disadvantage. It also harms the environment.

    And in my specific case, the doctor which prescribed the medicine absolutely denied that there was any connection between the side effects I was experiencing and the drug despite the fact that all the side effects were on the warning label.

    The pharmacists I talked to were completely unaware of the drug side effects. Like completely clueless. I think this can partially be attributed to the fact that CVS under staffs their pharmacies.

    Now I’m not saying that these antibiotics are horrible. They are quite amazing, its just that they are over used. Real life needs a major crimes unit like from the wire.

  37. TheLemon says:

    @mjsager: “And in my specific case, the doctor which prescribed the medicine absolutely denied that there was any connection between the side effects I was experiencing and the drug despite the fact that all the side effects were on the warning label.”

    When I had a severe reaction, the only reason I was taken seriously at the ER was because my doctor had experienced the exact same reaction herself when she took a sample pack of Levaquin for her own strep throat. No one else in the ER believed it was even possible to get that sick from taking an antibiotic. My primary was obviously doubting it , but eventually took the ER doc seriously. All of this told me that 1) I was incredibly lucky to get the doc I did in the ER, and 2) most docs have NO IDEA how serious and real some of these side effects are.

  38. Cerb says:

    @mjsager:

    We have been warned of the dangers of these drugs. Its literally drilled into our heads over and over in medical school. The fact remains, these are rare events for the most part. As the above poster mentioned, it is less than 1% in adult patients according to clinical trials and the benefit far outweighs the risks.
    As for not treating a sinus infection, that is false. If an infection is bacterial, we pretty much always treat it. It so happens that most cases of acute sinusitis are of viral origin, but if there is reason to suspect it is bacterial, standard of care is to treat it with an antibiotic (Augmentin is usually firt line but flouroquinolones are frequently used and quite effective as well). Again, flouroquinolones are VERY GOOD, MOSTLY SAFE drugs. They aren’t nukes of the antibiotic world, just good broad coverage abx.

  39. nsv says:

    @Phexerian:

    It’s kinda like myopathy with statins (Lipitor or Zocor). It has a rate of 1 in 10,000 but people get really uppity about it.

    Of all the people who take statins, how many of them could get their cholesterol down by using diet and exercise, which generally have the horrible side effects of making you lose weight and feel and look better?

    My mother was prescribed Lipitor with a cholesterol level of 185 and LDL LT 100. WHY? (Aside from the fact that her doctor is a bleeding idiot.) To maintain, the idiot told her. Is there some reason he couldn’t have told her to try mallwalking three or four times a week? Couldn’t he have asked about her diet and suggested minor changes to be made? Why prescribe a statin?

    If half the people taking statins don’t need them, we’ve doubled the number of people who will suffer side effects. (And made the pharmaceutical companies even richer, but let’s not go there.) And how many people go to their doctor to report minor side effects and get blown off? How many don’t even bother to report them?

    Statins are just one example, antibiotics are another. Doctors are prescribing meds that aren’t needed.

  40. *cringe* Besides getting kicked in the nuts, the though of tendons rupturing makes me feel sick. I was on Levaquin for a few days after a septoplasty last month and thank god nothing popped for me.

  41. modenastradale says:

    I was recently prescribed Levaquin for a sore throat. After the first dose, I had hallucinations and became agitated and nearly violent. We researched the drug online and learned of its serious side effects. I immediately ceased the drug and no longer will visit the physician who prescribed it (he gave me no warning whatsoever — in fact, he wasn’t even sure if my illness was bacterial).

    Yikes.

  42. Phexerian says:

    @nsv: I agree with you that antibiotics are over prescribed a good bit. I can’t tell you how many people come in with a z-pak script that I dont think they need.

    Yes, cholesterol can be lowered with more exercise and a better diet. Honestly, who the blame comes down to is the patients and the physicians. The patients think that if they just take this pill, they will instantly have better cholesterol. The physicians, care too lazy to counsel their patients and get to the real root of the problem, so they just dish out the statins. Not very many physicians that I have seen actually do this, but there are some. But once again, after the physician does their part, the patient has to do theirs.

    Generally, a physician should tell a patient to try exercise and dieting for a few months, then come back and re test and see if the cholesterol is a little better. If it is improving, good, keep diet and exercising. If not, then they put them on a statin.

    “If half the people taking statins don’t need them, we’ve doubled the number of people who will suffer side effects.”

    That is an excellent point. And like you said, it comes down to physicians over prescribing drugs and patients wanting to take the easy way out.

    “And how many people go to their doctor to report minor side effects and get blown off? How many don’t even bother to report them?”

    Many don’t. That is another one of the reasons we have post market studies and clinical trials. Unfortunately, these kinds of statistics can become skewed and biased, but that is another discussion that I could probably write a book on.

    -Phex
    -3rd Year PharmD / MBA Candidate

  43. FrancisGeben says:

    I was a healthy 42 year old male who took Levaquin for a sinus infection.
    The same day as the Black Box Warning was issued; I was having my third tendon
    reattachment surgery. I have to wait at least 6 weeks before I can undergo
    yet a fourth tendon rupture reattachment. At least it takes my mind of the
    Achilles Tendinopathy, joint pains, headaches, uncontrolled muscle twitching
    etc. I consider myself one of the lucky ones since so far it has not
    affected my kidneys, liver, heart, eyes and other side effects that many are
    dealing with from this class of drugs. I would urge a real journalist to take the
    time and look at the real number of cases. The Fda numbers are misleading.
    The clinical data coming from other counties are showing much higher rates of
    tendon ruptures and other life threatening side effects

    **************Get fantasy football with free live scoring. Sign up for
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  44. HunterDeiphobus says:

    Fluoroquinolone antibiotics have damaged many people.   I know of this severe damage on a personal level since I suffered such and adverse reaction to the fluoroquinolone antibiotic Levaquin myself 22 months ago.  Since then I have had daily pain and disability of my nervous and musculoskeletal systems and for several months had endocrine and gastrointestinal problems as well.  The disability and damage caused by fluoroquinolones is long term and may gradually escalate in that more severe problems such as worsened neuropathy, neuromuscular disorders, musculoskeletal disorders and endocrine disorders once initiated by the fluoroquinolones may develop with a delayed and insidious progress. 
     
    This progression of the fluoroquinolone toxicity syndrome is well know by its sufferers and not recognized by health care givers.  There has been no investigation in to the reactions.  This lack of attention stems from of an antiquated FDA reporting system and the under-representation of the seriousness and frequency of the adverse reactions.  The makers of fluoroquinolones have no interest in investigating adverse reactions when doing so will hurt them financially.  It is only recently with the weight of litigation pressing down that the FDA has published its incomplete and grossly inadequate boxed warning about the potential for fluoroquinolone toxicity. 
     
     
    I have met many other patients suffering from the adverse effects of fluoroquinolones.  Many of them reside in my community including 3 physicians and more than twenty patients. 
     
    Although these drugs may be life saving in certain infections when less toxic antibiotics may fail, they have been promoted for use as first line treatment for sinusitis, and urinary tract infections, and are often given indiscriminately to unsuspecting patients by uninformed and cavalier physicians for such benign illnesses as the common upper respiratory infection.   Unfortunately for many patients they are trading a mild short term medical problem for a serious long term one. 
     
    Sincerely,
     
     
    Todd Plumb MD

  45. Alex Brewer says:

    I’m allergic to beta lactam antibiotics, which means penicillins, cephalosporins, carbapenems, monobactams and beta-lactamase inhibitors. I’m on a course of azithromycin (z-pak) because I just got four wisdom teeth out and don’t have any problems/side effects.

  46. Zabella says:

    I am also allergic to beta lactums, and have suffered a number of sinus infections that have been treated with some serious antibiotics. I agree that antibiotics are over prescribed and I try not to take them if at all possible. With my sinus problems this involves lots of steaming, decongestants and trying to put up with the pain for as long as possible. There are some instances however where I would not call a sinus infection simple. I have had meningitis, a bone infection and an infection in my eye all at separate times caused by a long standing sinus infection… I still continue to avoid anti biotics if at all possible though. It is a cost benefit analysis really!

  47. RochelleGracchus says:

    Tendon rupture is the least of the patient’s concerns. This class is
    associated with irreversible peripheral neuropathy, fatal liver and kidney damage,
    fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous
    ruptures not only of the tendons but also muscles, ligaments and cartilage, the
    list of serious adrs is boundless. More than half of the drugs found in this
    class have been removed from clinical practice due to severe and even fatal
    adverse reactions.

    I just received a report of a 14year old male who tore the cartilage in both
    knees requiring extensive surgical intervention as a result of being on
    levaquin to treat a nail infection. Not to mention they young lady who has been
    in a wheelchair for the past decade due to the damage done to her tendons which
    rendered them beyond surgical repair. She was given cipro for an earache.

    Within the NDA (new drug application) for levofloxacin we find clinical
    studies that revealed an adr rate in excess of 40% (one or more reactions) and a
    number of listed fatalities. We find these same numbers with all the NDAs for
    this class. This tendon issue we are now discussing was first revealed to the
    FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen
    filed a petition in 1996 seeking both black box warnings and dear doctor
    letters. The FDA did neither. Another petition was filed by the Attorney General of
    the State of Illinois in 2005 seeking these same actions. In 2006 Public
    Citizen once again petitioned the FDA. Rather than respond to these petitions as
    required by law, the FDA stonewalled the petitioners for more than three
    years. It was not until suit was filed in Federal Court by Public Citizen to
    compel the FDA to respond to these petitions did the FDA do anything.

    And what they did was nothing more than a ‘slap to the face’ to those of us
    who have had our lives destroyed by these drugs. It is far too little, far too
    late. And we would not even be tossed this ‘bone’ if this lawsuit were not
    pending. This is nothing more than a blatant attempt by the FDA to avoid full
    disclosure of the true safety profile of this class which will be required
    when they lose in Federal Court.

    Bayer issued a European “Dear Doctor Letter” in February of 2008 in regards
    to fatal liver injury as a result of being on Avelox. Yet we see no such
    letter being issued here in the States, nor do we see the FDA requesting one
    either. This class has been crippling and killing patients since the mid
    sixties. For more than forty years now the FDA has hidden the true safety profile
    from both the patient as well as the treating physician.

    Those who have an interest in reading this forty years worth of medical
    journal entries, case reports, newspaper articles, clinical studies, etc., that
    documents all that I state here are invited to log unto _www.fqresearch.org_
    (http://www.fqresearch.org) The FDA is also grossly misleading when they
    state that the risk factor is one in one hundred thousand. The actual risk is .5%
    to 16% depending upon which citation you prefer to reference as well as the
    year in which it was published.

    I find the manufacturers to be grossly misleading the patient and physician
    alike when they state that this class is a safe and effective antibiotic with
    minimum side effects. I have forty years worth of medical documentation that
    proves that they are anything but for those who care to read it, rather than
    this line of misleading and false information being provided by the FDA.

    Mr. David T. Fuller
    Director
    Fluoroquinolone Toxicity Research Foundation
    _www.fqresearch.org_ (http://www.fqresearch.org)
    _fqresearch@aol.com_ (mailto:fqresearch@aol.com)
    _davidtfull@aol.com_ (mailto:davidtfull@aol.com)

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  48. RochelleGracchus says:

    Tendon rupture is the least of the patient’s concerns. This class is
    associated with irreversible peripheral neuropathy, fatal liver and kidney damage,
    fatal hypo and hyperglycemia, SJS and TEN, toxic psychosis, spontaneous
    ruptures not only of the tendons but also muscles, ligaments and cartilage, the
    list of serious adrs is boundless. More than half of the drugs found in this
    class have been removed from clinical practice due to severe and even fatal
    adverse reactions.

    I just received a report of a 14year old male who tore the cartilage in both
    knees requiring extensive surgical intervention as a result of being on
    levaquin to treat a nail infection. Not to mention they young lady who has been
    in a wheelchair for the past decade due to the damage done to her tendons which
    rendered them beyond surgical repair. She was given cipro for an earache.

    Within the NDA (new drug application) for levofloxacin we find clinical
    studies that revealed an adr rate in excess of 40% (one or more reactions) and a
    number of listed fatalities. We find these same numbers with all the NDAs for
    this class. This tendon issue we are now discussing was first revealed to the
    FDA back in 1982 (bailey et al). The FDA did NOTHING until Public Citizen
    filed a petition in 1996 seeking both black box warnings and dear doctor
    letters. The FDA did neither. Another petition was filed by the Attorney General of
    the State of Illinois in 2005 seeking these same actions. In 2006 Public
    Citizen once again petitioned the FDA. Rather than respond to these petitions as
    required by law, the FDA stonewalled the petitioners for more than three
    years. It was not until suit was filed in Federal Court by Public Citizen to
    compel the FDA to respond to these petitions did the FDA do anything.

    And what they did was nothing more than a ‘slap to the face’ to those of us
    who have had our lives destroyed by these drugs. It is far too little, far too
    late. And we would not even be tossed this ‘bone’ if this lawsuit were not
    pending. This is nothing more than a blatant attempt by the FDA to avoid full
    disclosure of the true safety profile of this class which will be required
    when they lose in Federal Court.

    Bayer issued a European “Dear Doctor Letter” in February of 2008 in regards
    to fatal liver injury as a result of being on Avelox. Yet we see no such
    letter being issued here in the States, nor do we see the FDA requesting one
    either. This class has been crippling and killing patients since the mid
    sixties. For more than forty years now the FDA has hidden the true safety profile
    from both the patient as well as the treating physician.

    Those who have an interest in reading this forty years worth of medical
    journal entries, case reports, newspaper articles, clinical studies, etc., that
    documents all that I state here are invited to log unto _www.fqresearch.org_
    (http://www.fqresearch.org) The FDA is also grossly misleading when they
    state that the risk factor is one in one hundred thousand. The actual risk is .5%
    to 16% depending upon which citation you prefer to reference as well as the
    year in which it was published.

    I find the manufacturers to be grossly misleading the patient and physician
    alike when they state that this class is a safe and effective antibiotic with
    minimum side effects. I have forty years worth of medical documentation that
    proves that they are anything but for those who care to read it, rather than
    this line of misleading and false information being provided by the FDA.

    Mr. David T. Fuller
    Director
    Fluoroquinolone Toxicity Research Foundation
    http://www.fqresearch.org

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  49. teriaw says:

    I think it’s great to see more publicity about fluoroquinolone side effects. Many doctors forget that patients have a right to be informed about side effects, or perhaps doctors are not informed of side effects well enough to have intelligent conversations about them with their patients. I had a conversation with my doctor about possible side effects of Levaquin before I took it, and my doctor never mentioned tendon disorders, and convinced me to take the Levaquin since it’d be no problem for me to switch to a different antibiotic if I did have side effects. Or so we both thought.
    Luckily my mom came across a publication by Public Citizen that talked about tendon damage by fluoroquinolones when I was 7 days into my 14+day course of Levaquin. I’d been wondering why my achilles were so sore and my calves so rock hard. Four years later with continued tendon and nerve pain, I’m still regretting that initial assumption that side effects go away when I quit ingesting the pills. But if this is what the result of 7 days of Levaquin is like, thank goodness for that article by Public Citizen that kept me from taking 14 days worth of pills. I am a formerly healthy, active 35 year old.

  50. RochelleGracchus says:

    We have been warned of the dangers of these drugs. Its literally drilled
    into our heads over and over in medical school.

    Then WHY pray tell are so many physicians so grossly uninformed concerning
    the safety profile of this class?
    The fact remains, these are rare events for the most part. As the above
    poster mentioned, it is less than 1% in adult patients according to clinical
    trials and the benefit far outweighs the risks.

    Your killing me here, nothing could possibly be further from the truth. The
    risk factor as stated within any number of publications range anywhere from
    .5% to 16%. This is NOT one in a hundred by any means. And this fails to
    take into account the gross number of such ruptures that were NEVER properly
    associated with the fluoroquinolones by the treating physician. And do not
    point to clinical studies please, I have read more entertaining fairy tales
    written by the Brother’s Grimm. For example in one study three patients suffered
    such a rupture. It was NOT reported as it was not one of the listed adverse
    reactions that were part of the trials protocal.

    As for not treating a sinus infection, that is false. If an infection is
    bacterial, we pretty much always treat it. It so happens that most cases of
    acute sinusitis are of viral origin, but if there is reason to suspect it is
    bacterial, standard of care is to treat it with an antibiotic (Augmentin is
    usually firt line but flouroquinolones are frequently used and quite effective as
    well). Again, flouroquinolones are VERY GOOD, MOSTLY SAFE drugs. They aren’t
    nukes of the antibiotic world, just good broad coverage abx.

    If a drug that can cripple a patient for life, cause irreversible peripheral
    nueropathy, fatal damage to a patients vital organs, and totally trashes the
    patient’s DNA is to be considered a “VERY GOOD, MOSTLY SAFE DRUG,” what is
    to be considered a defective drug in comparison? Arsenic perhaps rather than
    this proven toxic form of chemotherapy?

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  51. kyle4 says:

    This is why, unless I’m going to die of a disease, I don’t take medications. I learned from the past, and it’s so terribly tragic that yet another medication is injuring people.

  52. Phexerian says:

    Your FQResearch.org website does not have the research available to look at on their website, and therefor, I can’t take your post for having much substance at the current time.

    The only part of your post that had any substance was the time line regarding the FDA’s actions to the petition. You did not really cite anything, but it is implied that it is accurate since it is pretty common knowledge and can be looked up easily.

    Dr Plumbs post is quite informative and for the most part I agree with it. I must admit that I am not that familiar with the tendon problem side effect of the drug but am only familiar from rxlist.com that the rate of occurrence is less than 1%. This is what was reported to the FDA in clinical trials I would assume. This number could change after more of a population starts to take the drug, and thus the reason for post market research and surveillance. But, like the good doctor said, the FDA is antiquated in its reporting system, and as I have added in, are underfunded and understaffed. I would also like to add in that they have a revolving door policy with big pharma which is a huge conflict of interest. After one works for big pharma for a while, and they leave, they can get a job easily with the fda and vice versa.

    Because the drug companies must pay “fees” yearly to the FDA, it has come to the point where big pharma is actually funding the drug companies. I would assume pretty close to the same amount as the tax payers are. This is creates another conflict of interest. The persons whom they are supposed to be regulating, are the ones that fund them.

    If there is a higher rate than 1% for the tendon side effects, the FDA should state it blatantly. One must understand though, that us health care practitioners can only prescribe and go with the data that is given to us. If the AMA looked at all the literature on it, and regarded it as safe to prescribe and effective for certain disease states, then physicians must go by the guidelines given by the AMA. I would assume that the literature on FQresearch.org has been taken into account already though I could be wrong.

    Until the guidelines change, prescribing habits of physicians are probably not going to change regarding this class of antibiotics. I hope at the least that this black box warning turns some heads.

    -Phex
    -3rd Year PharmD / MBA Candidate

  53. Phexerian says:

    EDIT: The research forum does work, just was a badly designed website. The literature is overwhelming. I hope you don’t expect me to dig through it completely. I also wonder, is all the literature anti fluoroquinolone?

    After a brief look at some of the research directly related to tendon rupture, most of them are only case reports or just articles that are in the news. Case reports are not considered substantial and are only there to say “Hey look at me! This could possibly be researched!!”

    There are only a handful of actual research articles on tendon effects. This archive of research info is mostly crap. Half of the articles aren’t completely there, and only give a brief overview.

    Perhaps if this website wanted to be more effective, it would 1) do a better job of designing its website 2) make the research easier to access 3) not put up complete crap in the research archive section.

    Perhaps you should, next time you post, cite some direct research. Thanks.

    -Phex
    -3rd Year PharmD / MBA Candidate

  54. RochelleGracchus says:

    This class is associated with irreversible peripheral neuropathy, fatal
    liver and kidney damage, fatal hypo and hyperglycemia, SJS and TEN, toxic
    psychosis, spontaneous ruptures not only of the tendons but also muscles, ligaments
    and cartilage, the list of serious adrs is boundless.

    Citations: (this is just a very brief list for the tendon issues alone. The
    total list regarding the tendon issues is well over 48 pages, single
    spaced.) These citations are numbered and spaced. But for some reason they do not
    appear this way when posted here. So with a little effort you may have to
    cut and paste this into your word processor and add the spacing back in. I
    have added ( ) around the number corresponding to each citation.

    (1) Nalidixic Acid arthralgia
    Bailey et al (CMA Journal 1972; 107 601-605)

    (2) Norfloxacin induced rheumatic disease
    Bailey et al (NZ Med J 1983; 96; 590)

    (3) 100 reported tendinopathies 1985-1992 France
    In France, between 1985 and 1992, 100 patients who were being managed with
    fluoroquinolones had tendon disorders, which included thirty-one ruptures
    (Royer, R. J.; Pierfitte, C.; and Netter, P.: Features of tendon disorders with
    fluoroquinolones. Therapie, 49: 75-76, 1994.)
    _http://www.studiomedico.it/allegati/achille.pdf_
    (http://www.studiomedico.it/allegati/achille.pdf)

    (4) Tendon disorders attributed to fluoroquinolones; a study on 42
    spontaneous reports in the period 1988-1998
    Van Der Linden et al (American College of Rheumatology; Arthritis Care and
    Research 45; 2001 pages

    (5) Perrot S, Ziza JM, De Bourran-Cauet G, Desplaces N, Lachand AT.
    [A new complication related to quinolones: rupture of Achilles tendon]
    Presse Med. 1991 Jul 6-13;20(26):1234. French. No abstract available.
    PMID: 1831902 [PubMed - indexed for MEDLINE]

    (6) Seven Achilles tendinitis including three complicated by rupture during
    fluoroquinolone therapy
    Ribard et al (J Rheumatol 1992; 19; 1479-1481)

    (7) 704 achilles tendinitis, 38 ruptures 1992-1998 Netherlands
    Fluoroquinolone use and the change in incidence of tendon rupture in the
    Netherlands
    Van der Linden et al (Pharmacy World and Science vol 23 no 3 2001 pg 89-92)
    The cohort included 46 776 users of fluoroquinolones between 1 July 1992 and
    30 June 30 1998, of whom 704 had Achilles tendinitis and 38 had Achilles
    tendon rupture
    source: _http://bmj.com/cgi/content/full/324/7349/1306_
    (http://bmj.com/cgi/content/full/324/7349/1306)

    (8) Royer RJ, Pierfitte C, Netter P.
    Features of tendon disorders with fluoroquinolones.
    Therapie. 1994 Jan-Feb;49(1):75-6. No abstract available.
    PMID: 8091374 [PubMed - indexed for MEDLINE]

    (9) Dekens-Konter JA, Knol A, Olsson S, Meyboom RH, de Koning GH.
    [Tendinitis of the Achilles tendon caused by pefloxacin and other
    fluoroquinolone derivatives]
    Ned Tijdschr Geneeskd. 1994 Mar 5;138(10):528-31. Dutch.
    PMID: 8139714 [PubMed - indexed for MEDLINE]

    (10) Szarfman A, Chen M, Blum MD. More on fluoroquinolone antibiotics
    and tendon rupture. N Engl J Med 1995; 332: 193[Free Full Text].

    (11) Pierfitte C, Royer RJ.
    Tendon disorders with fluoroquinolones.
    Therapie. 1996 Jul-Aug;51(4):419-20. No abstract available.
    PMID: 8953821 [PubMed - indexed for MEDLINE]

    (12) Castagnola C, Suhler A.
    [Tendinopathy and fluoroquinolones]
    Ann Urol (Paris). 1996;30(3):129-30. French.
    PMID: 8766149 [PubMed - indexed for MEDLINE]

    (13) Maki T, Heinasmaki T, Riutta J, Tikkanen T, Laasonen L, Eklund K.
    [Bilateral Achilles tendon rupture caused by oral fluoroquinolones]
    Duodecim. 1996;112(19):1818-20. Finnish. No abstract available.
    PMID: 10596182 [PubMed – indexed for MEDLINE

    (14) 130 reported tendon inflammation or rupture (England, France and
    Belgium, 1996)
    The group cited 130 reports of tendon inflammation or rupture in people who
    used the prescription drug in England, France and Belgium. The FDA has
    received at least 52 reports of patients in the U.S. who have suffered tendon damage

    (15) FRANCE
    921 reported tendon disorders France
    340 reported tendonitis, 81 tendon ruptures 1996, WHO
    Adverse drug reactions with fluoroquinolones The French system of drug
    surveillance has analyzed the reports of adverse drug reactions (ADRs) to
    fluoroquinolones since they were launched. The frequency of reactions ranges from
    1/15000 to 1/208000 case per days of treatment. Cutaneous disorders and tendon
    disorders dominate in France, whereas cutaneous effects and neuropsychiatric
    disorders are predominant in the UK; tendon disorders take up only the 5th
    position. Among the most unexpected ADRs are the following: 1- Shock 2- Acure
    renal failure Tendon ruptures represent 81 cases for 921 reports of tendon
    disorders which are related in decreasing order to pefloxacin 1/23130 case per
    days of treatment, ofloxin, norfloxacin and ciprofloxacin 1/779600 case per
    days of treatment. Age and corticosteroids increase the risk of tendon rupture.
    Therapie 1996; 51; 419-420 Tendon disorders with fluoroquinolones 421 cases
    have been collected by the Centre de Pharmacovigilance: 340 of tendinitis and
    81 of tendon rupture. These cases were attributed to Peflacine, Oflocet,
    Noroxine, Ciflox. Tendinitis was characterized by a bilateral malleolar oedema
    associated with a sudden pain. Sometimes this oedema evoked phlebitis. The
    tendon rupture was generally preceded by a tendinitis but in half of the cases it
    occurred without warning.
    Source: _http://www.who-umc.org/newsletter/newsltr97_1.html_
    (http://www.who-umc.org/newsletter/newsltr97_1.html) (sic)

    (16) Australia.
    The Adverse Drug Reactions Advisory Committee first reported tendinitis in
    association with fluoroquinolone antibiotics in 1997. The Committee has
    continued to monitor this adverse reaction, and has now received 60 reports of
    tendinitis, tensosynovitis and/or tendon rupture in association with these drugs.
    Ciprofloxacin was most frequently cited (55 reports), as well as norfloxacin
    (4) and enoxacin (1).
    Forty-five reports described tendinitis alone, one report described
    tensosynovitis, and 14 reports documented tendon tear or rupture. Fifty-five of the
    60 reports specified the Achilles tendon, including 20 which described
    bilateral Achilles tendon damage. All 14 reports of tendon rupture involved the
    Achilles tendon. The 58 patients ranged in age from 38 to 91 years (median: 69),
    with no significant difference between those with tendinitis and those with
    tendon rupture.
    The daily doses of ciprofloxacin ranged from 500 mg to 2250 mg, with 46% of
    patients taking 1500 mg and 46% of patients taking 1000 mg daily. For those
    who developed tendon rupture, 57% were taking 1500 mg daily. Time to onset
    varied from within 24 hours after the drug was commenced to 3 months after
    starting, but the majority of cases of tendinitis occurred within the first week.
    Time to rupture was longer with a median time of 2-3 weeks. Known risk
    factors for these reactions include old age, renal dysfunction and concomitant
    corticosteroid therapy. In the cases reported to the ADRAC, 29 reports documented
    concomitant corticosteroid use, and in 21 of the other 31 reports the
    patients were aged 69 years or older. In the reports of tendon rupture, 12 of the
    14 described either concomitant steroid use (9) or old age (9).
    Prescribers are reminded to be alert for this reaction and to withdraw the
    fluoroquinolone immediately when symptoms of tendinitis appear in order to
    reduce the risk of tendon rupture.
    [See also Pharmaceuticals Newsletter Nos. 7&8, July&August 1997.]
    Tendinitis associated with Fluoroquinolone therapy
    (Pharmaceuticals Newsletters Nos 7&8 July & August 1997)

    (17) van der Linden PD, van Puijenbroek EP, Feenstra J, Veld BA,
    Sturkenboom MC, Herings RM, Leufkens HG, Stricker BH.
    Tendon disorders attributed to fluoroquinolones: a study on 42 spontaneous
    reports in the period 1988 to 1998. Arthritis Rheum. 2001 Jun;45(3):235-9.
    PMID: 11409663 [PubMed - indexed for MEDLINE]

    (18) NETHERLANDS
    704 achilles tendinitis, 38 ruptures 1992-1998 Netherlands
    Fluoroquinolone use and the change in incidence of tendon rupture in the
    Netherlands
    Van der Linden et al (Pharmacy World and Science vol 23 no 3 2001 pg 89-92)
    The cohort included 46 776 users of fluoroquinolones between 1 July 1992 and
    30 June 30 1998, of whom 704 had Achilles tendinitis and 38 had Achilles
    tendon rupture
    source: _http://bmj.com/cgi/content/full/324/7349/1306_
    (http://bmj.com/cgi/content/full/324/7349/1306)

    (19) Harrell RM.
    Fluoroquinolone-induced tendinopathy: what do we know?
    South Med J. 1999 Jun;92(6):622-5. Review.
    PMID: 10372859 [PubMed - indexed for MEDLINE]

    (20) van der Linden PD, van de Lei J, Nab HW, Knol A, Stricker BH.
    Achilles tendinitis associated with fluoroquinolones.
    Br J Clin Pharmacol. 1999 Sep;48(3):433-7.
    PMID: 10510157 [PubMed - indexed for MEDLINE]

    (21) 60 reported tendonitis August 1999
    Fluoroquinolones tendinitis update Australia
    Tendinitis associated with Fluoroquinolone therapy
    (Pharmaceuticals Newsletters Nos 7&8 July & August 1997)
    Australia
    ADRAC Bulletin, vol 18, No 3, August 1999
    Tendinitis and tendon rupture with fluoroquinolones
    The Adverse Drug Reactions Advisory Committee (ADRAC) first reported
    tendinitis in association with the fluoroquinolone antibiotics in 1997. The
    Committee has continued to monitor this adverse
    reaction, and has now received 60 reports of tendinitis, tenosynovitis
    and/or tendon rupture in association with these drugs. Most involved was
    ciprofloxacin (55), but there were also reports with norfloxacin (4) and enoxacin (1).
    Fortyfive reports described tendinitis alone, one report described
    tenosynovitis, and 14 reports documented tendon tear or rupture. Fifty five of the 60
    reports specified the Achilles tendon, including 20 which described bilateral
    Achilles tendon damage. All 14 reports of tendon rupture
    involved the Achilles tendon.
    Source: _http://www.who.int/medicines/library/pnewslet/pndec99.html_
    (http://www.who.int/medicines/library/pnewslet/pndec99.html)

    (22) 421 reported tendon disorders and 81 tendon ruptures 1999
    Therapie 1996; 51: 419-420 Tendon disorders with fluoroquinolones 421 cases
    have been collected by the Centre de Pharmacovigilance, 340 of tendinitis and
    81 cases of tendon rupture.

    (23) Infection. 2000 Jul-Aug;28(4):256-7.
    Fluoroquinolone-induced tendinopathy: also occurring with levofloxacin.

    (24) Quinolone and Tendon Ruptures
    Casperian et al (Southern Medical Journal May 2000 vol 93 no 5 pages 488-491)

    (25) Rupture of the patellar ligament one month after treatment with
    fluoroquinolone
    Rev Chir Orthop Reparatrice Appar Mot. 2000 Sep;86(5):495-7.

    (26) FINLAND
    42 reported tendinopathies 2000
    Finland:
    Register of adverse drug reactions in 2000
    The majority of ADR reports received among antibacterials concerned
    levofloxacin, which is a fluoroquinolone antibiotic. Fourteen of the reports were on
    tendinitis or rupture of the Achilles tendon. Tendinitis caused by
    fluoroquinolones was discussed in TABU for the first time in 1996. Since then the ADR
    register has received a total of 42 reports on tendinopathies caused by
    fluoroquinolones, over a third of which were ruptures of the tendon.
    The use of fluoroquinolones has in-creased by about 75% since 1996.
    Levofloxacin is responsible for the major part of this increase. It has been marketed
    in Finland since mid 1998.
    source: _www.nam.fi/uploads/english/Publications/Tabu/tabu22001_eng.pdf_
    (http://www.nam.fi/uploads/english/Publications/Tabu/tabu22001_eng.pdf)

    (27) Pharm World Sci. 2001 Jun;23(3):89-92.
    Fluoroquinolone use and the change in incidence of tendon ruptures in the
    Netherlands.
    van der Linden PD, Nab HW, Simonian S, Stricker BH, Leufkens HG, Herings RM.

    (28) 1847 reported tendinopathies December 2001
    Tabelle 7
    Pharmacovigilance: Meldungen von Tendinopathien im Vergleich zu allen
    gemeldeten unerwünschten Arzneimittelwirkungen (UAW), Stand 17. Dezember 2001.

    (29) Van der Linden et al (Pharmacy World and Science vol 23 no 3 2001 pg
    89-92)
    The cohort included 46 776 users of fluoroquinolones between 1 July 1992 and
    30 June 30 1998, of whom 704 had Achilles tendinitis and 38 had Achilles
    tendon rupture
    source: _http://bmj.com/cgi/content/full/324/7349/1306_
    (http://bmj.com/cgi/content/full/324/7349/1306)

    (30) van der Linden PD, Sturkenboom MC, Herings RM, Leufkens HG, Stricker
    BH.
    Fluoroquinolones and risk of Achilles tendon disorders: case-control study.
    BMJ. 2002 Jun 1;324(7349):1306-7. No abstract available.
    PMID: 12039823 [PubMed - indexed for MEDLINE]

    (31) Breck RW.
    “Ciprofloxacin: a warning for clinicians”.
    Conn Med. 2002 Oct;66(10):635. No abstract available.
    PMID: 12448217 [PubMed - indexed for MEDLINE]

    (32) Journal of Antimicrobial Chemotherapy (2003) 51, 747–748
    DOI: 10.1093/jac/dkg081
    Advance Access publication 28 January 2003
    Correspondence
    Spontaneous Achilles tendon rupture in patients
    treated with levofloxacin
    L. J. Haddow, M. Chandra Sekhar, V. Hajela and
    G. Gopal Rao

    (33) Cetti R, Junge J, Vyberg M.
    Spontaneous rupture of the Achilles tendon is preceded by widespread and
    bilateral tendon damage and ipsilateral inflammation: a clinical and
    histopathologic study of 60 patients.
    Acta Orthop Scand. 2003 Feb;74(1):78-84.
    PMID: 12635798 [PubMed - indexed for MEDLINE]

    (34) Khaliq Y, Zhanel GG.
    Fluoroquinolone-associated tendinopathy: a critical review of the literature.
    Clin Infect Dis. 2003 Jun 1;36(11):1404-10. Epub 2003 May 20. Review.
    PMID: 12766835 [PubMed - indexed for MEDLINE]

    (35) Haddow LJ, Chandra Sekhar M, Hajela V, Gopal Rao G.
    Spontaneous Achilles tendon rupture in patients treated with levofloxacin.
    J Antimicrob Chemother. 2003 Mar;51(3):747-8. No abstract available.
    PMID: 12615887 [PubMed - indexed for MEDLINE]

    (36) Vergara Fernandez I.
    [Muscle and tendon problems as a side-effect of levofloxacine: review of a
    case]
    Aten Primaria. 2004 Mar 15;33(4):214. Spanish. No abstract available.
    PMID: 15023326 [PubMed - indexed for MEDLINE]

    (37) Long term outcome after Fluoroquinolones tendinopathies
    13/01/2004 14:11:07 P-0077
    C Guy (1); Y Murat (1); MN Beyens (1); M Ratrema (1); G Mounier (1); M
    Ollagnier (1); (1) Centre de Pharmacovigilance, H̫pital Bellevue РCHU St-Etienne,
    Sant-Etienne

    (38) Toxicology. 2005 May 9
    Fluoroquinolones cause changes in extracellular matrix, signalling proteins,
    metalloproteinases and caspase-3 in cultured human tendon cells.
    Sendzik J, Shakibaei M, Schafer-Korting M, Stahlmann R.

    (39) DUTCH
    Fluoroquinolones have been associated with tendon disorders, usually during
    the first month of treatment,1-5 but the epidemiological evidence is scanty.
    We did a nested case-control study among users of fluoroquinolones in a large
    UK general practice database to study the association with Achilles tendon
    disorders.

    Participants, methods, and results

    We obtained data from the IMS Health database (UK MediPlus), which contains
    data from general practice on consultations, morbidity, prescriptions, and
    other interventions in a source population of 1-2 million inhabitants. The base
    cohort consisted of all patients aged 18 years or over who had received a
    fluoroquinolone. We excluded people with a history of Achilles tendon disorders,
    cancer, AIDS, illicit drug use, or alcohol misuse. We identified potential
    cases by reviewing patient profiles and clinical data and excluded tendon
    disorders due to direct trauma. We randomly sampled a group of 10 000 control
    patients from the study cohort.

    We defined four categories of exposure to fluoroquinolones: current use,
    recent use, past use, and no use. We defined current use as when the tendon
    disorder occurred in the period between the start of the fluoroquinolone
    treatment and the calculated end date plus 30 days, recent use as when the calculated
    end date was between 30 and 90 days before the occurrence of the disorder,
    and past use as when the calculated end date was more than 90 days before the
    occurrence of the disorder. We used unconditional logistic regression
    analysis to calculate adjusted relative risks and 95% confidence intervals for
    Achilles tendon disorders, using the no use group as the reference. We adjusted
    for age, sex, number of visits to the general practitioner, use of
    corticosteroid, calendar year, obesity, and history of musculoskeletal disorders.

    The cohort included 46 776 users of fluoroquinolones between 1 July 1992 and
    30 June 30 1998, of whom 704 had Achilles tendinitis and 38 had Achilles
    tendon rupture. Four hundred and fifty three (61%) of the cases were women, and
    the mean age was 56 years. Cases visited the general practitioner
    significantly more often than did controls (mean 20 v 17). Cases and controls were
    similar with respect to indications for use of fluoroquinolone. Age, number of
    visits to the general practitioner in the previous 18 months, gout, obesity, and
    use of corticosteroid were determinants of Achilles tendon disorders. The
    adjusted relative risk of Achilles tendon disorders with current use of
    fluoroquinolones was 1.9 (95% confidence interval 1.3 to 2.6). The risk for recent
    and past use was similar to that for no use. The relative risk with current use
    was 3.2 (2.1 to 4.9) among patients aged 60 and over and 0.9 (0.5 to 1.6)
    among patients aged under 60 (table). In patients aged 60 or over, concurrent
    use of corticosteroids and fluoroquinolones increased the risk to 6.2 (3.0 to
    12.8).

    Relative risk of Achilles tendon disorders associated with use of
    fluoroquinolones according to age
    Current exposure to fluoroquinolones increases the risk of Achilles tendon
    disorders. This finding is in agreement with a smaller study, in which we
    found an association between tendinitis and fluoroquinolones.5 Our results
    indicate that this adverse effect is relatively rare, with an overall excess risk
    of 3.2 cases per 1000 patient years. The effect seems to be restricted to
    people aged 60 or over, and within this group concomitant use of corticosteroids
    increased the risk substantially. The proportion of Achilles tendon disorders
    among patients with both risk factors that is attributable to their
    interaction was 87%. Although the mechanism is unknown, the sudden onset of some
    tendinopathies, occasionally after a single dose of a fluoroquinolone, suggests a
    direct toxic effect on collagen fibres. Prescribers should be aware of this
    risk, especially in elderly people taking corticosteroids.

    (40) McGarvey WC, Singh D, Trevino SG.
    Partial Achilles tendon ruptures associated with fluoroquinolone
    antibiotics: a
    case report and literature review.
    Foot Ankle Int. 1996 Aug;17(8):496-8. Review.
    PMID: 8863030 [PubMed - indexed for MEDLINE]

    As well as the recent pediatric studies:
    Safety Review of the five pediatric trials relied upon by the FDA to grant
    an extension of pediatric exclusivity to Johnson and Johnson:
    1st Study: Of the 712 subjects evaluable for safety, 275 (52%)
    levofloxacin-treated subjects experienced 1 or more adverse event. Seventeen subjects
    had 23 adverse events of marked severity. Twenty-three subjects experienced
    MS adverse events. Serious adverse events were reported in 33 (6%)
    levofloxacin-treated subjects. Two serious adverse events in levofloxacin-treated
    subjects resulted in fatal outcomes. Adverse events leading to treatment
    discontinuation occurred in 12 (2%).

    2nd Study: Of the 204 subjects evaluable for safety, 122 experienced 1 or
    more adverse events. Twelve were marked in severity: Twelve subjects (6%)
    discontinued study drug due to an adverse event. Six subjects experienced a
    MS adverse event. There were no deaths. Seven subjects (3%) experienced 8
    serious adverse events.

    3rd Study: Results of this study are not available even though they are
    required to be posted on the clinicaltrials.gov website within one year of
    completion. There is not conclusions posted on that site as of 3-26-2008

    4th Study: Results of this study will not be available for about 15-20
    years. Patients who develop one or more musculoskeletal disorders during the
    first year will be monitored until they have completed puberty (15th birthday for
    females and 17th birthday for males).

    5th Study: Results of this study are not available even though they are
    required to be posted on the clinicaltrials.gov website within one year of
    completion. There is not conclusions posted on that site as of 3-26-2008. The
    results of this study have not been posted on clinicaltrials.gov as required by
    law. No results available to be posted as none can be found at this time, even
    though Federal Law requires that they be available through the
    clinicaltrials.gov website a through search failed to locate this study and the results
    thereto.

    Within the NDA (new drug application) for levofloxacin we find clinical
    studies that revealed an adr rate in excess of 40% (one or more reactions) and a
    number of listed fatalities. Citing to the NDA for levaquin, readily available
    on the FDA website in a PDF format.

    Bayer issued a European “Dear Doctor Letter” in February of 2008 in regards
    to fatal liver injury as a result of being on Avelox. Citing to the letter
    that is readily available on the research site under the Breaking News
    heading. You can also follow this link to read the letter as well:
    _http://tinyurl.com/5t23dm_ (http://tinyurl.com/5t23dm)

    I fail to understand why you would have such a problem with the research
    site. All you have to do is click on whatever adr you are interested in.
    Choose any citation from the list presented, and then read it. If the full text
    is not available that would be the result of copyright problems, or it is a ‘
    pay to view’ article, which most of the negative articles are exactly that.
    So do a google search and spend some of your hard earn cash for the right to
    read it. It is not I that makes you do that but either the author or the drug
    company that does not want such information to be readily available. This
    is NO different than what would be required of you on pubmed. They too
    present a list, some with nothing more than the citation, others with just the
    abstract, and if you are lucky the full article. If this is good enough for
    pubmed, than I would it believe it to be good enough for you.

    If the majority of these articles are to be considered ‘crap’ then I would
    imagine they fail to support the propaganda presented by the drug companies in
    your view. And NO the site is balanced and shows all of the relevant data
    that could be found concerning this class. The good, the bad, and the ugly.
    Again it is not to be considered my fault that the majority of the articles
    found there reveal a horrendous safety profile. I did not write them, I am
    simply presenting them in their original form. If you care to I am more than
    willing to flood this site with citations supporting everything that I have
    stated. Just point out one of the listed adrs I mentioned that you feel have
    nothing to do with fluoroquinolone therapy and I will do exactly that. You
    are scaring me that a college kid can’t figure out how to click on a link and
    then follow it to the list of citations.

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  55. RochelleGracchus says:

    As you can see, trying to include citations just makes a miserable mess of
    the post. Rather than complain about the fqresearch website, (you must of
    failed to notice the sign that asked you to forgive the mess it currently is in
    do to the fact that it is undergoing an extensive remodeling), take a moment
    and consider why it would even be needed. As you stated the amount of data
    found there is overwhelming. I would find that to be rather odd considering
    how rare you seem to believe these reactions are.

    I must admit that I am not that familiar with the tendon problem side effect
    of the drug but am only familiar from rxlist.com that the rate of occurrence
    is less than 1%. This is what was reported to the FDA in clinical trials I
    would assume. This number could change after more of a population starts to
    take the drug, and thus the reason for post market research and surveillance.

    But you stated that you consider such reports to be unsubstantiated. So
    what goes does it do to report them if the medical community considers them to
    be suspect? A classic catch 22. Clinical studies are hardly to be considered
    to be any more valid. Almost all of these adverse events we are discussing
    indeed did presented during the trials but the drug company doctors stated
    that they were NOT related to the study drug even though there was no other
    logical explanation. Even those that had been reported upon in the medical
    journals. Still not related to the drug they would state. In one trial three
    patients had a rupture. This fact was EXCLUDED from the final report.

    Since this site here does such a horrible job butchering comments sent via
    email (still can’t log in even though I am registered here) I will provide you
    a link to a list of the citations being used on that site (which will open in
    Word) and you can do a bit of research yourself.

    There are are only a handful of actual research articles on tendon effects.
    This archive of research info is mostly crap. Half of the articles aren’t
    completely there, and only give a brief overview. I beg to differ here. I have
    well over 400 citations from 1962-2005. Due to medical complications I am
    about three years behind in adding data to the site. The hard copies fill
    four file cabinets. The reason you do not have access to the full articles is
    beyond my control. They are not available to the public without having to
    purchase them. So you take 11,497 medical journal entries (1982-2004) found on
    Pub Med

    _http://tinyurl.com/6saopd_ (http://tinyurl.com/6saopd)
    then factor in that a couple of thousand of these articles will cost
    anywhere from $50-$150 a piece and the cost becomes prohibited. Other articles are
    so old that the originals cannot even be found. This isn’t the Library of
    Congress my friend. It is a website put together by one victim of the
    horrendous damage caused by these drugs who is doing the best he can with what he has
    to work with. And as I state in a previous post it is rather straight
    forward to use. Three clicks of your mouse is all it takes. Couldn’t get any
    easier than that.

    TENDONS: _http://tinyurl.com/6xk3mn_ (http://tinyurl.com/6xk3mn)
    Tendon Ruptures / Animal Studies: _http://tinyurl.com/5g3zgg_
    (http://tinyurl.com/5g3zgg)
    DNA DAMAGE: _http://tinyurl.com/6dlg5d_ (http://tinyurl.com/6dlg5d)
    IRREVERSILBE PERIPHERAL NUEROPATHY: _http://tinyurl.com/6o4wbt_
    (http://tinyurl.com/6o4wbt)
    VISION DAMAGE: _http://tinyurl.com/6684yh_ (http://tinyurl.com/6684yh)
    CARDIAC EVENTS: _http://tinyurl.com/5engvh_ (http://tinyurl.com/5engvh)
    Rhabdomyolysis: _http://tinyurl.com/6ghdbb_ (http://tinyurl.com/6ghdbb)
    LIVER DAMAGE: _http://tinyurl.com/6brdyg_ (http://tinyurl.com/6brdyg)
    KIDNEY DAMAGE: _http://tinyurl.com/6927yh_ (http://tinyurl.com/6927yh)
    PROSTATITIS: _http://tinyurl.com/6b9583_ (http://tinyurl.com/6b9583)
    VASCULITIS: _http://tinyurl.com/6ffoug_ (http://tinyurl.com/6ffoug)
    TENS, SJS, Phototoxicity and Skin Damage: _http://tinyurl.com/5fda6p_
    (http://tinyurl.com/5fda6p)
    Toxic Psychosis: _http://tinyurl.com/65v5sv_ (http://tinyurl.com/65v5sv)
    PEDIATRIC USE: _http://tinyurl.com/6r3kqo_ (http://tinyurl.com/6r3kqo)
    REMOVED FROM CLINICAL USE: _http://tinyurl.com/5khtv4_
    (http://tinyurl.com/5khtv4)
    HUMAN AND ANIMAL STUDIES: _http://tinyurl.com/6x9nfl_
    (http://tinyurl.com/6x9nfl)
    Blood Disorders: _http://tinyurl.com/5m7wfp_ (http://tinyurl.com/5m7wfp)
    Causation: _http://tinyurl.com/62dxab_ (http://tinyurl.com/62dxab)
    Central Nervous and Peripheral Nervous System: _http://tinyurl.com/55wrzj_
    (http://tinyurl.com/55wrzj)
    Gastrointestinal: _http://tinyurl.com/69mo2b_ (http://tinyurl.com/69mo2b)
    Hypoglycemia: _http://tinyurl.com/5quwpk_ (http://tinyurl.com/5quwpk)
    Litigation: _http://tinyurl.com/5bfccj_ (http://tinyurl.com/5bfccj)
    DRUG RESIDUE IN MEAT AND POULTRY: _http://tinyurl.com/6kzwhd_
    (http://tinyurl.com/6kzwhd)
    Misc Published / Newspaper Reports: _http://tinyurl.com/5vmr8d_
    (http://tinyurl.com/5vmr8d)
    Sleep Disturbances: _http://tinyurl.com/6ypvbx_ (http://tinyurl.com/6ypvbx)
    False and Misleading Statements: _http://tinyurl.com/6gf43u_
    (http://tinyurl.com/6gf43u)
    Dear Doctor Letters / Medical Alerts: _http://tinyurl.com/62w56n_
    (http://tinyurl.com/62w56n)
    Scripting Abuse: _http://tinyurl.com/5f6fhg_ (http://tinyurl.com/5f6fhg)
    Fluoroquinolone Fatalities: _http://tinyurl.com/5hobqn_
    (http://tinyurl.com/5hobqn)
    Post Marketing: _http://tinyurl.com/6ajryb_ (http://tinyurl.com/6ajryb)

    As well as the following attachments:

    _Attachment A Post Marketing Reports VIA Quinolone ADR Forums_
    (http://fqresearch.org/attachments/Attachment_A.doc)

    _Attachment B Vision Problems Reported Medications.com_
    (http://fqresearch.org/attachments/Attachment_B.doc)
    _Attachment C FDA Advisory Committee RE: Moxifloxacin Cardiac Events_
    (http://fqresearch.org/attachments/Attachment_C.doc)
    _Attachment D Vasculitis _
    (http://fqresearch.org/attachments/Attachment_D.doc)
    _Attachment E Toxic Psychosis (1 of 3)_
    (http://fqresearch.org/attachments/Attachment_E.doc)
    _Attachment F Toxic Psychosis (2 of 3)_
    (http://fqresearch.org/attachments/Attachment_F.doc)
    _Attachment G Toxic Psychosis (3 of 3)_
    (http://fqresearch.org/attachments/Attachment_G.doc)
    _Attachment H Mutagenicity (1 of 2)_
    (http://fqresearch.org/attachments/Attachment_H.doc)
    _Attachment I Pediatric MedWatch Reports (1 of 2) (w/ Fatalities)_
    (http://fqresearch.org/attachments/Attachment_I.doc)
    _Attachment J Breastfeeding and Quinolones_
    (http://fqresearch.org/attachments/Attachment_J.doc)
    _Attachment K 62nd Meeting of the Anti-Infective Drugs Advisory Committee_
    (http://fqresearch.org/attachments/Attachment_K.doc)
    _Attachment L QT Intervals Moxifloxacin_
    (http://fqresearch.org/attachments/Attachment_L.doc)
    _Attachment M Mechanism of Action_
    (http://fqresearch.org/attachments/Attachment_M.doc)
    _Attachment N Pneumonia Contra Indicated_
    (http://fqresearch.org/attachments/Attachment_N.doc)
    _Attachment O Pseudotumor Cerebi _
    (http://fqresearch.org/attachments/Attachment_O.doc)
    _Attachment P Mutagenicity (2 of 2)_
    (http://fqresearch.org/attachments/Attachment_P.doc)
    _Attachment Q Pediatric MedWatch Reports (2 of 2) _
    (http://fqresearch.org/attachments/Attachment_Q.doc)
    _Attachment R Guilty Plea in Drug Residue Case_
    (http://fqresearch.org/attachments/Attachment_R.doc)
    _Attachment S Detection of Drug Residue _
    (http://fqresearch.org/attachments/Attachment_S.doc)
    _Attachment T Warnings Ignored Raxar_
    (http://fqresearch.org/attachments/Attachment_T.doc)
    _Attachment U Bayer Accused of Fraud_
    (http://fqresearch.org/attachments/Attachment_U.doc)
    _Attachment V Lariam and Fluoroquinolones Chemical Structures_
    (http://fqresearch.org/attachments/Attachment_V.doc)
    _Attachment W Market Share Unapproved Usage_
    (http://fqresearch.org/attachments/Attachment_W.doc)
    _Attachment X Adverse Profile Quinolones_
    (http://fqresearch.org/attachments/Attachment_X.doc)
    _Attachment Y Post Marketing Reports Postal Workers_
    (http://fqresearch.org/attachments/Attachment_Y.doc)
    _Attachment Z Bayer; Fraud and Unethical Behavior_
    (http://fqresearch.org/attachments/Attachment_Z.doc)
    _Attachment AA Post Marketing Reports (1 of 3)_
    (http://fqresearch.org/attachments/Attachment_AA.doc)
    _Attachment BB Post Marketing Reports (2 of 3)_
    (http://fqresearch.org/attachments/Attachment_BB.doc)
    _Attachment CC Post Marketing Reports (3 of 3) _
    (http://fqresearch.org/attachments/Attachment_CC.doc)
    _Attachment DD Non Abating Vision Damage_
    (http://fqresearch.org/attachments/Attachment_DD.doc)
    _Attachment EE Quotes from Peter Ball and Glen Tillotson_
    (http://fqresearch.org/attachments/Attachment_EE.doc)
    _Attachment FF Ortho McNeil _
    (http://fqresearch.org/attachments/Attachment_FF.doc)
    _Attachment GG Moxifloxacin _
    (http://fqresearch.org/attachments/Attachment_GG.doc)
    _Attachment HH 62nd Advisory Meeting Pediatrics_
    (http://fqresearch.org/attachments/Attachment_HH.doc)
    _Attachment II Pediatric MedWatch Reports_
    (http://fqresearch.org/attachments/Attachment_II.doc)

    _Attachment A-1Warning Letters_
    (http://fqresearch.org/attachments/Attachment_A-1.doc)

    _Attachment A-2 DNA DAMAGE_
    (http://fqresearch.org/attachments/Attachement_A-2.doc)

    _Attachment A-3 Tendon Damage Associated with Fluoroquinolone Use, Reported
    in the Literature (1972-2005)_
    (http://fqresearch.org/attachments/Attachment_A-3.doc)

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  56. Phexerian says:

    1) Citing 40+ different research cases is ludicrous. Expecting me to read and sift through 40 of them is even more ludicrous. That is a job for fqresearch.org or the AMA. When I said cite something, I mean cite something with substance. Where is the retrospective meta analysis? I see there were a couple of studies with a good population number. Not all of those research studies are going to be considered strong.
    2) Many of the older studies that were published over 20 years ago can be found online for free. Don’t need PubMed to get to them. There are some people like me that do have access to PubMed. However, if you really want people to look into this more, you need to present the case in an easier manner. Don’t give the public 500+ cases and say “Here you go, sift through it”. Give them the good meta analysis and retrospective studies with good population numbers with sound statistics methodology.
    3) “author or the drug company that does not want such information to be readily available.” It is standard practice for ALL medical research to be done this way generally. I guess one could argue what you said.
    4) “This is NO different than what would be required of you on pubmed.” With PubMed you can narrow the fields down much quicker and easier. Once again, don’t expect the reader to do all the sifting for you. Present your argument in a cleaner manner.
    5) “If the majority of these articles are to be considered ‘crap’ then I would imagine they fail to support the propaganda presented by the drug companies in your view.” Then one could argue they also fail to support your claim as well.
    6) “You are scaring me that a college kid can’t figure out how to click on a link and then follow it to the list of citations.” There was no need for the ad hominem attack. It’s not college btw, its professional graduate school. Please note, that I am working on my Doctorate in Pharmacy and these studies and this research I deal with on a daily basis in class. Once again, when we get studies, we only get the ones that are to be considered relevant by the medical community, then we weigh the options. Flooding the page with 40+ citations again, is still requiring the reader to sift through all the crap. Just post the most relevant studies or at least what you think are the most relevant studies. 40+ if them is quite a lot to consider to be statistically relevant.
    7) “I would find that to be rather odd considering how rare you seem to believe these reactions are.” What I believe is irrelevant. I have to go with the data that the medical community thinks is worthwhile. We do have standards and rules as to studies, how they are done, etc…
    8) “But you stated that you consider such reports to be unsubstantiated. So what goes does it do to report them if the medical community considers them to be suspect?” Case Reports are unsubstantial is what I said. They have no statistical backing. They are there to open up the discussion and door for more research and statistical analysis. A Retrospective metaanalysis is not unsubstantial. A strong study is substantial.
    9) “Clinical studies are hardly to be considered to be any more valid.” Clincal studies, unlike Case Reports, use statistical methods to determine outcomes. So no, you are wrong. They are much more valid, however, only to the extent of how well they are done.
    10) “I beg to differ here. I have well over 400 citations from 1962-2005.” 400 citations does not mean they are all well designed research studies. I’m sure many of them are case reports. Once again, make the literature easy to locate for the point you are making.

    Once again, you tell me that the reader, me, should sift through all this data. I can’t make an informed idea about your argument without GOOD supporting data and quite frankly, I cannot sift through all that data myself. It is unreasonable to expect one to do that. This is why, when you argue a point, quality is worth more than quantity. Find the good studies and use those for your arguments. If you aren’t sure which ones are good, see if you can find a friend who knows something about it to help you out or take a design outcomes statistics class which shows you how to do that.

    Also, present your case to the AMA and the other groups that design the guidelines for medical practice. Arguing to the FDA is good as well, but it can only get you so far. The guildelines being changed is what will change medical practice and help people. If what you are stating is true and the rate is higher, by putting other safer antibiotics in at first line treatment instead of fluoroquinolones will help save people.

    I hope you realize that I am not being negative to your cause. I am very critical though when it comes to statistics and medical research. It needs to be very transparent. I am treating you with the same rigor that I would treat a drug rep or a drug company so don’t think I am singling you out. I am willing to believe it but there has to be data to support it that is of quality. And honestly, I don’t like drug companies, and I like finding stuff like this that drug companies hide when they try to put their drug on the market, but once again, the data has to be of quality and easy to access. Good luck to you.

    -Phex
    -3rd Year PharmD / MBA Candidate

  57. lableslea says:

    My name is Leslea and I am a Clinical Laboratory Manager, have been a Medical Technologist for almost 30 years. I am very well respected by the medical staff at my facility because if I bring up a subject, perhaps a laboratory protocol that I want to put into place or changed, I have done my homework on the subject.
    With that in mind, I want to urge physicians to take heed to the fact that fluoroquinolones are not safe for a very large segment of the population. There are literally thousands and thousands of people whose lives are forever changed because of the quinolones.
    I know that most, if not all, facilities with microbiology departments put out an antibiogram, at least annually, for the medical staff to reference. Please use your antibiograms to pick the least toxic and most effective antibiotic for your patient.
    Use the quinolone class only as a last resort, after other antibiotics have failed or the patient will expire if they aren’t used. Using the quinolones routinely just doesn’t make sense when other antibiotics will work. Keep in mind if this class of antibiotics continues to be used so nonchalantly they will become ineffective due to bacteria developing resistance to them.
    I have personally experienced multiple system adr’s to the quinolones, and know a multitude of people like me. That is why I am writing this, I want to prevent the number of people that are damaged by quinolones from growing exponentially.
    The adr’s to the quinolones are grossly under reported due to the fact that a lot of reactions aren’t recognized, but are diagnosed as an unrelated problem. If the number of adr’s to quinolones were accurately reported to the medical community, no physician would ever routinely prescribe quinolones again, unless he was some sort of sadist.
    My motivation for writing this is honorable, our term would be risk management in the medical community, for the layperson it would be a passionate desire to prevent others from suffering like I am.
    Just in case you are wondering, my first reaction to a quinolone caused damage to my tendons particularly my left knee. The tendons were so weak that my knee dislocated 6 times over a 7 month period, I probably should have been in a wheel chair, but I needed to work. I have a permanent baker’s cyst in that knee. The tendonitis was so painful that walking was more like hobbling.
    My second reaction made my first reaction seem like a walk in the park. When I mentioned multiple systems earlier, I meant CNS, muscular, skeletal, soft tissues and connective tissue damage. Four and a half years post two doses of Avelox, I still have a multitude of symptoms, some that are not going to resolve. Although I am in severe unrelenting pain, I consider the worst part of my reaction to be the CNS or brain damage.
    I have debilitating depression, which I never had prior to this. But the thing that takes the cake is the following: I am sure you can imagine that I am or actually was above average in intelligence, Avelox has destroyed my short term memory and has made me struggle to find simple everyday words when carrying on a conversation. My nickname used to be “The Steel Trap” because I never forgot anything and could recall verbatim conversations no matter how long or short the amount of time that had elapsed. My memory was what is called photographic in nature. You might be tempted to say, well you are getting older, well I don’t believe that CNS changes due to aging happen overnight unless there is a stroke involved. That, and the fact that I am not alone with this reaction, speaks very loudly to the truth of the matter.
    I will quickly list the other damage I am dealing with; peripheral neuropathy, myofascial damage in my right hip that has lead to permanent gluteus median adhesions after tearing. I have chronic muscle spasms and knots in my right hip and shoulder, this is the cause of the severe unrelenting pain, the shoulder knots and spasms lead to horrible tension headaches. I also have to take Valtrex to keep shingles at bay, another wonderful symptom of the nerve damage. My tendons and ligaments in my right knee are tender to the touch and painful, my vision is altered due to floaters and blurring, luckily laboratories are notoriously noisy so I don’t notice the tinnitus too much. I could go on and on, but you get the picture. By the way, I was a healthy active person prior to this reaction, I was 47 at the time and most people would guess my age at 35 because of my personality, strength and agility, they were always shocked to find out how old I was.
    Please help me in preventing any other healthy individuals from experiencing this nightmare.
    I also challenge you to do your own research into the real picture of this class of antibiotics, quit taking the word of the FDA or pharmaceutical companies, they have an agenda, but it is less than honorable. You can start by going to http://www.fluoroquinolones.org .
    Thank you for your time.

  58. RochelleGracchus says:

    My comments were not meant to be argumentative either. I am treating you
    in the same manner as any one else who doesn’t have a clue. I take no
    offense in debating this with you, and in fact respect the fact that you are
    even bothering to take the time to discuss this further. I hate the way
    this site makes this text appear, but I am powerless to do anything about it so
    please bare with me here. You stated that: I am willing to believe it but
    there has to be data to support it that is of quality. OK, I agree,
    that is a reasonable request. So where does one find such data when nobody
    is compiling it? You cannot do a meta analysis on something that is
    grossly under reported. The data is simply not there to work with for that
    very reason. You have a clinical study, three patients blow a tendon, and
    the study makes NO mention of this fact. So what is there to analysis when
    this takes place. One could state a risk factor of say one in a
    thousand. But this is meaningless when 900 additional cases were never reported
    to begin with. The 40 citations was simply being used to stress the point
    that this has been reported since 1982. One citation per year more or
    less. For the FDA to act as if this was something new is mind boggling when
    it has been reported in the medical journals for twenty six years. For a
    physician to claim to have NO knowledge of this reaction simply does not fly in
    the face of what is out there.

    So as you can see from the following, what is the use of pursuing the
    suggestions you are making?

    The applicant selected a HIGHER dose than that approved for clarithromycin
    for the treatment of CAP. It should also be noted that clarithromycin is
    NOT approved for CAP due to H. influenzae and therefore may not be the best
    comparator for the purpose of assessing moxifloxacin efficacy in infections
    caused by this agent. The use of this higher dose of clarithromycin for CAP
    CANNOT be used to substantiate ANY potential claims of an enhanced safety
    profile for moxifloxacin compared with clarithromycin.

    The MO reviewed the narratives for patients with serious AES and found that
    there were two patients who developed empyemas and two who developed worsening
    of pneumonia whose serious AEs were considered by the applicant to be
    UNRELATED to study drug. Review of these cases suggested that all three of
    these patients’s deteriorations WERE related to the study drug. The MO was
    UNABLE to determine why the applicant considered some clinical deterioration’s
    attributable and others unattributable to the study drug.

    The clinical efficacy of moxifloxacin daily for 10 days observed in this
    study was comparable to what has been observed with this regime in other studies
    of CAP. This study DID NOT provide sufficient to support a claim for
    clinical efficacy of moxifloxacin in the treatment of pneumonia due to S. aureus
    or K. pneumoniae. The adverse event and laboratory abnormalities profile
    seen for moxifloxacin in this study was similar to what was reported from
    other studies.

    The applicant presented additional data regarding clinical efficacy in the
    per protocol population at follow up. Cure rates for each treatment group
    were 18/33 (54.6%) for moxifloxacin 200 m.g. 19/35 (54.3%) for moxifloxacin
    400 m.g. and 61/104 (66.7%) for amoxicillin 500 mg tid. This study DID
    NOT distinguish between the clinical efficacy of moxifloxacin 200 mg and
    moxifloxacin 400 mg for the treatment of CAP. It SUGGESTED that moxifloxacin may
    be similar to amoxicillin 500 mg tid in the treatment of this infection. (NOT
    SUPERIOR)

    Hence, the conflicting data presented in the NDA do(es) NOT convincingly
    support approval of the 7 day moxifloxacin regimen for acute sinusitis
    indication.

    Moxifloxacin clearly prolongs QTc intervals in a concentration-related
    manner and as a result puts patients at risk for developing malignant arrhytmias.
    The data provided by the sponsor DID NOT include all patients treated, about
    90% were excluded, and ECG were obtained as late as 6 hours after the drug
    intake (peak concentration is about 2 hours). So the sponsor’s argument
    that moxifloxacin is safe because it only causes a small increase in QTc is
    flawed. What was shown in the database is that there are examples of
    patients on moxifloxacin with changes in QTc intervals greater than 80 msec over
    baseline with resulting QTc intervals above 500 msec.

    In summary, it is hard to justify approving this agent as a first line
    therapy for non-life threatening infections in which there are a plethora of
    treatment choices. Moxifloxacin raises the QTc interval in a concentration
    related manner and therefore has the potential to cause malignant ventricular
    arrhythmias, including torsade de pointes, and death. (were do you see this
    stated in the product label in a black box?)

    I recommend approval of moxifloxacin for the treatment of CAP due to S.
    pneumoniae, H. influenzae, M. catarrhalis, Mycoplasma pneumoniae and Chlamydia
    pneumoniae.

    In conclusion the MO recommends approval of the ten day treatment regimen of
    moxifloxacin for the treatment of acute sinusitis…drug related adverse
    events occurred more commonly in the moxifloxacin group (37%) compared to the
    control group…however the elevation of the prothrombin time, cholesterol and
    chloride occurred more frequently in the moxifloxacin treatment arm.

    The FDA approved this drug even thought the studies failed to show any
    advantage over the comprators presented, as well as stating that: Moxifloxacin
    raises the QTc interval in a concentration related manner and therefore has the
    potential to cause malignant ventricular arrhythmias, including torsade de
    pointes, and death.

    Even though all of these issues were raised by the advisory committee before
    hand:

    Excerpts from the ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE 67TH MEETING
    (THURSDAY, OCTOBER 21, 1999) in which the severe adverse reactions to moxifloxacin
    were discussed.

    The following is the text of pertinent portion of this meeting:
    QUOTES FROM THE HEARING:
    Committee Doc A: I’m going to say no, and I’m going to say no because of the
    following reasons. I think when the drug is marketed, no matter what kind of
    warning you put in it, it’s going to be used in substantially different ways
    than it’s been used in the trials. And, I think that this is exactly the
    kind of place that you get into trouble with, when a drug is approved, it’s
    carefully studied in a trial, people are carefully excluded who have prolonged QT
    intervals, are carefully excluded who are on drugs that can be additive with
    it in terms of the effect, and it’s used for a very short interval of time,
    and so it’s not clear — I am absolutely convinced that the drug will be used
    differently once it’s marketed frequently. And, I think there are enough
    things that really haven’t been answered. I don’t know if the drug effects
    potassium and magnesium excretion, and whether it somehow is additive with other
    drugs that produces increased loss of electrolytes through the kidneys,
    because that has not been looked at. It seems to possibly cause or increase the
    incidence of atrial fibrillation, and we don’t have real drug levels from real
    patients correlated with QT times. So, I don’t know, I’m just somewhat
    concerned. The other issue with safety, obviously, is the risk benefit ratio, and
    I’m not sure I see what this drug adds to drugs that we already have that’s so
    unique that we need this drug, that we absolutely need it, and we need it
    now for some indication. There are other drugs that you can use. They may have
    the same problem, but given that they haven’t been studied in this way, I
    don’t know that’s the case.——
    COMMITTEE DOC B: Well, I guess I’d have to say no, the data on safety are
    not convincing. It seems to me, based on the discussion, that the QT facts are
    clinically relevant, steady state concentrations needs to be studied further.
    In addition, the concern about people using the drug for longer than 12
    days, I don’t think we have enough information on that, and I believe that that
    may occur, even though that probably would not necessarily be what we would
    recommend. The other concerns about other drugs that might prolong the QT
    interval, the problems with hypokalemia, the problems with death after the drug
    was discontinued, and, again, the age-old problem, the use of this drug in
    children, I think we need to study the drug and the pharmacokinetics, and we also
    need to study the safety in the pediatric population. We need data on that,
    because although it was not studied, and although it won’t be approved for chi
    ldren, I’m afraid it will be used in this population and I’m concerned about
    that.—-
    COMMITTEE DOC C: I was prepared to vote for safety with an appropriate
    change in the label, but the two that have talked about all the things that we
    don’t know about, you know, the behavior of this drug have swayed me. I think I
    shall have to vote against, I don’t believe we know enough yet about the
    safety because of the cardiac problems.—-
    Guest Expert Doc A: I was — I thought Dr. A’s summary captured a lot of my
    concerns, and I think that on balance we don’t know enough now to conclude
    that it’s safe. I think the other thing that gives me pause is the fact that
    this is a drug that may be very widely used, so even if the estimates of one
    to two percent, which I think are very conservative, of meaningful QT
    prolongations are correct, that might be tens or hundreds of thousands of people who
    would experience those. So, it seems to me that knowing more would be
    necessary for me to say yes, so I think if I had a vote I would probably say no for
    now.—-
    ACTING CHAIRMAN : And finally, I’d like to make sure that there are no other
    comments that the voting members of the committee would like to make.—-
    Committee Doc D: I just have one comment, which also echoes a little bit
    what Dr. A said, which is that although I think this drug is safe, I think we
    also have to consider the other drugs, other antibiotics that are out there,
    and whether the risk benefit ratio is as good as other comparators or similar
    drugs that are there. And, I think in balance this probably doesn’t add a
    terrible — it doesn’t add very much to the antibiotic armamentarium that we
    currently have.——
    Dr. A: I’m a little confused by what we are voting on. I mean, my answer is
    still no from before. I agree that if the drug is approved that it has to
    have a warning label similar to what’s been described. I also wonder whether it
    shouldn’t include something about the possibility that it may induce atrial
    fibrillation in patients, particularly, patients at high risk for that
    arrhythmia. And, you know, whether it should contain information about the drug
    effect on QT may be aggravated by hypokalemia and, therefore, potassium levels,
    particularly, on patients who are on drugs that cause hypokalemia should be
    monitored, or at least baseline checked. I mean, I think there may be other
    things that need to go into the warning label to caution people. I would also
    suggest that it say something about the fact that in the trials prolonged use
    of the drug, in terms of its cardiovascular safety, were not assessed, you
    know, by giving it longer than stated You know, in terms of the other drugs
    that have been approved, I guess one of the problems that the pharmaceutical
    company has here is that, you know, they were, perhaps, the first to come along,
    take a drug with this issue and evaluate it so thoroughly, so it’s probably,
    you know, raised as many questions as it has answered.—-
    DR. A: Do you have data on how this drug affects potassium and magnesium
    excretion from the kidney? The second question, in terms of the accumulation of
    this drug in tissues, over what time period does that occur? What is the half
    life in tissues? Is it likely if people use the drug for longer periods of
    time that the drug would continue to accumulate and levels would continue to
    rise in tissues?—-
    DRUG CO. DOC: We do have some tissue accumulation studies in Phase I and
    Phase II and in small numbers of patients multiple time points. We also have a
    dialysis and skeletal muscle study. Most of those studies, however, were done
    with a single dose administration of very short term. There is, as Dr.
    __showed you, considerable accumulation in pulmonary tissues which is helpful in
    this sort of setting. Our data for skeletal muscle is that the concentrations
    reached in skeletal muscle are about 80 percent of the plasma concentrations
    of the drug. We don’t have data to address the possibility of long-term
    accumulation in tissues but for skeletal muscle the ratios are less than plasma
    concentrations.—–

    So less than 8 weeks after this hearing where all these issues were raised,
    as well as all of the issues noted within the NDA, it was approved ANYHOW.
    _http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t2.rtf_
    (http://www.fda.gov/ohrms/dockets/ac/99/transcpt/3558t2.rtf)

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  59. Phexerian says:

    Interesting transcript. It is a very interesting read. Looks like the FDA should not have approved AVELOX for acute sinusitis infections as they are very much short term and generally easy to cure. The others, however, I could see as very complex infections in a hospital setting.

    Regarding QT elongation which I am somewhat familiar with. Standard practice, from what I have seen in pharmacy, is that we do not generally worry about QT elongation unless the patient has cardio problems or the drug interacts with another, like TCA (tricyclic Antidepressants). However, when we do find then, we always and I do mean always, call the physician and request that he change it to another drug. This is taken from rxlist.com …

    “No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 9,200 patients in controlled clinical studies, including 223 patients who were hypokalemic at the start of treatment, and there was no increase in mortality in over 18,000 moxifloxacin tablet treated patients in a post-marketing observational study in which ECGs were not performed.”

    However, I have not looked up these studies myself. These studies may be funded directly from the drug company which gives me a HUGE RED FLAG as towards bias. However, note that one of these huge studies was done POST marketing which means it came out after it was approved by the FDA. I can only assume that in its clinical studies, it was looked at, but not to a very thorough extent as stated by the physicians in your post.

    I will probably skim over that hearing a good bit more and see what else is in it. Nice find.

    -Phex
    -3rd Year PharmD / MBA Candidate

  60. mrearly2 says:

    The drug company must have been threatened with law suits, otherwise the FDA wouldn’t bother with a warning. They normally help the drug companies poison people.

  61. RochelleGracchus says:

    phex,

    If you were to review the NDA’s for these drugs as well as the text of the
    advisory meetings you will find that the above was not unique at all. But
    rather the rule. For instance disfiguring rashes is associated with Factive.
    In fact the advisory board members found this to be a hoot, and were literally
    laughing out loud about it. Factive is now scarring people for life. As I
    had posted earlier back in ’96 the advisory committee discussed how these
    drugs would crippled children. But pediatric studies took place anyhow, and
    crippled children. Same with tequin and hypo-hyperglycemia. Discussed, ignored
    then approved. Tequin has been removed as a result of fatal
    hypo-hyperglycemia. On and on we go. The vitro efficacy studies presented with the NDA for
    levaquin were not even for levaquin, but rather a different drug. Approved
    anyhow by the FDA. The corruption and malfeasance concerning this class in
    particular is staggering. Hence the reason we do not see fair warnings.
    Something is horribly wrong here when the FDA punishes those who raise the issue
    of safety and reward those who look the other way.

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  62. ciprovictimalso says:

    I have a big problem with the warnings on quinolones. The part of the warning that refers to “rare occurrence of tendonitis & tendon ruptures can occur while or AFTER taking these medicines” really needs more clarity. My husband took Cipro in 1998. Around 11 months “after” he started having ruptures to occur in his legs in 1999. He had another rupture in 2000 & 1 more in 2001. I notice the quadriceps isn’t mentioned as 1 of those listed in the warning. He also had a quadriceps muscle to tear apart in the center of his thigh. I see no mention of muscles rupturing but they certainly can. The rupturing seemed to have stopped for several years. In 2005, they started again mysteriously. This time he had 3 ruptures involving both his arms and the pain became worse in his legs. It just so happens these ruptures started occurring around 11 months “after” he took CiproXr. This was the second time he had ever taken a Cipro medicine. I have taken him to see almost a dozen different doctors since the ruptures first began. None of them had any idea what was causing it. I can understand why. Who knows that “AFTER” means more than a few weeks or months after taking these medicines. Then there is the word “RARE”. How do you know it’s that rare when almost a dozen different doctors couldn’t connect 6 ruptures in 1 man to quinolones? He was in his early 40’s when he took Cipro in 1998. The warning says that people over 60 are more at risks. How about listing the age group that reported the most tendon ruptures after taking these meds. I don’t believe they were over 60 years old. The warnings need to be more specific so doctors can recognize these injuries when they occur.

  63. rickadeemus says:

    I took avelox 3 plus years ago for a sinus infection, and three months later a barrage of ADRs hit me. Not connecting my condition to the use of a fluoroquinolone, I went around the med. establishment for 5 1/2 months looking for answers, none of which were forthcoming. The med. establishment does not look for ADRs to drugs in their diagnostic paradigm. And because they don’t, alot of people are being mis-diagnosed. ADRs to FQs mimic alot of conditions; sojgrens, arthritis, diabetes; the list goes on.

    These drugs are being abused by the medical community; they should not be given as a first line of defense against things like sinus infection or UTI.
    Also, doctors are not aware that they should not mix FQs with NSAIDS or steroids. God forbid we should tell anybody that and risk the patient not wanting the drug! The profit margin is the bottom line here, not the patients’ health and well-being. The FDA shares the responsibility for this negligence.

    The recent black box warning for tendon tears is very inadequate. The warning should be for ALL the FQ ADRs….neurological, GI, musculoskeletal, endocrinal, renal, liver, heart problems, etc.

    The other notable thing about these drugs is that the ADRs to FQs are often permanent. The warning to discontinue use and call your doctor is futile in that the damage has already been done by the time you get an ADR. Some people recover most of their lives back but it sometimes takes years.

    It’s time to get the word out regarding the danger of fluroquinolones before more people’s lives are ruined.

    Rick

  64. ciprovictimalso says:

    I don’t blame the doctors for what happened to my husband. He’s disabled now after the last 3 ruptures he had involving both his arms in 2005 after taking CiproXR. This started happening around 11 months after taking it. That was all he had left to work with. Both his legs were already badly damaged from when he took Cipro in 1998. He started having ruptures in both his legs around 11 months after taking Cipro 500mg. The ruptures came with no warning & also included the quadriceps & quadriceps muscle. A quadriceps muscle tore in half midway up his thigh. That’s just the tendon & muscle damage. He also has neuropathies in his arms & legs among other things. He had 6 ruptures & not a single doctor knew why. That “rare occurrence of tendinitis & tendon ruptures can occur while or AFTER taking these medicines” probably had a lot to do with why the doctors didn’t know. Who knew “AFTER” means that long. Someone asked “How does this(ruptures) happen?”. I’m not a doctor. I have read through so many of my husband’s medical records. There was mention of lack of blood in his tissue in a report after an operation he had. It was important enough that the doctor told me about it after the operation. My husband is a former Marine. He kept in shape over the years. He was in his early 40’s when he took Cipro in 1998. He worked out with a world class weight lifter in the military. He once was so strong. When his legs were badly damaged, he told me that as long as he had 2 good arms, he was going to make a living for his family. The second round of Cipro took that away. Can you imagine how he must feel now because his little grandchildren are stronger than he is. I have been told that the benefits outweigh the risks. What about his life? Why isn’t someone held responsible for this? If I made a product & sold it to people & some got hurt, I would be held responsibly. Why aren’t they?

  65. RochelleGracchus says:

    Though I had posted this on other sites dealing with this issue, it is still
    relevant to the discussion at hand and I would hope the host of this site
    would not take offense at me repeating it here:

    In addition to the recent “Black Box Warnings” as well as the European “Dear
    Doctor” issued by Bayer overseas back in February 2008 concerning Avelox,
    the European Medicines Agency has moved to severely restrict the use of Avelox
    (moxifloxacin), to wit:

    FRANKFURT, July 24 (Reuters) – The European Medicines Agency has recommended
    limiting the use of oral moxifloxacin-containing medicines after finalizing
    a review of the safety of the antibiotics, the agency said on Thursday.

    The European body (EMEA) said it had concluded that these drugs should only
    be prescribed for acute bacterial sinusitis, acute exacerbation of chronic
    bronchitis and community-acquired pneumonia when other antibiotics cannot be
    used or have failed.

    “The agency also recommended strengthening the warnings for oral
    moxifloxacin medicines,” it said in a statement.

    Moxifloxacin, a fluoroquinolone antibiotic, is marketed by Bayer (BAYG.DE:
    Quote, Profile, Research) under its brand Avelox.

    At its July 2008 meeting, the agency’s Committee for Medicinal Products for
    Human Use (CHMP) concluded that the benefits of oral moxifloxacin medicines
    continued to outweigh its risks.

    However, due to safety concerns, mainly related to an increased risk of
    adverse hepatic reactions, it recommended restricting their use in these
    indications.

    The CHMP opinion will now be forwarded to the European Commission to apply
    to all oral moxifloxacin-containing medicines authorized in the European Union.

    Responding to the recommendation, Bayer said the review confirmed the
    positive benefit-risk profile of the drug.

    “We would welcome an EMEA assessment of other antibiotics used for treatment
    of these infections in a similar fashion in the interest of patient care,”
    said Kemal Malik, a member of Bayer HealthCare executive committee and chief
    medical officer.

    _http://uk.reuters.com/article/governmentFilingsNews/idUKL2453307820080724_
    (http://uk.reuters.com/article/governmentFilingsNews/idUKL2453307820080724)

    Black Box Warnings, Dear Doctor Letters, restrictions place on the use of
    Avelox, thousands of patients responding to these articles claiming severe
    injuries from this class, hundreds if not thousands of adverse drug reaction
    forums with tens of thousands of members world wide, as well as more than fifty
    percent of these drugs removed from clinical practice, and last but not least
    the fact that Nalidixic Acid, upon which all these drugs are based is a listed
    cancer causing agent, I dare to ask: are we still to believe the following
    comment which can be found at the end of just about any article written about
    this class?

    ‘The fluoroquinolones as a class are generally well tolerated; most adverse
    effects are mild in severity, self-limited, and rarely result in treatment
    discontinuation…’

    Or are we to continue wonder if we are the only ones who have bothered to do
    any research on this class in the past twenty six years. For surely who ever
    would make such a claim has not.

    “Repeat a lie a thousand times and it becomes the truth …” – usually
    credited to Dr Joseph Goebbels, Propaganda Minister of the Third Reich. I now
    credit it to those medical researchers who continue to state how safe and
    effective this class of chemotherapuetic agents are. For they have repeated this
    lie a thousand times a thousand times. Rather odd coincident that they are both
    (Goebbels, and these medical researchers who state such blatant lies) members
    of the medical community.

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  66. radams257 says:

    I think having a black box warning should just be the first step in a total re-education program for doctors. When I was given ciprofloxin in January 2008 for a sinus infection, I had terrible side effects – tendon pain and stiffness being only the tip of the iceberg – which I promptly reported to my treating physician only to be told it couldn’t be caused by the meds. When I pointed out that the warning sheet from the pharmacy said tendon issues were a side effect and to immediately report this to my treating physician, the doctor just shrugged it off and told me my problems were not caused by the cipro. I am sure if I went back to that same doctor today with my continued tendon pains and tendon stiffness and with a copy of the new black box warning, he wold still act as if this fq medication could never cause my issues. It is ridiculous how trained professionals act so completely clueless or brainwashed – you can choose which they are.

    Also, everyone keeps going on and on about how “rare” the side effects are. What a complete distortion of the truth. First, anyone who browses the internet will find several sites where fluoroquinolone victims have been posting for years, and these sites contain thousands of members with allegedly “rare” side effects. Second, we also must factor in that doctors don’t report the side effects of these drugs. I personally know that my doctor didn’t report my side effects when I went back to him, and I have since discovered that several members of my immediate family have sustained “rare” injuries that were never reported to the FDA while they just happened to be taking fluoroquinolones: my paternal granfather had an achilles tendon rupture 4-5 years ago while taking levaquin; my maternal grandmother had severe central nervous system issues as well as debilitating deteoriation of her legs muscles after taking a course of levaquin and then avelox several years ago; and my mother-in-law had central nervous system issues with levaquin after 1 pill and refuses to take another fluoroquinolone. Wow I just found 4 “rare” side effects in my family; none of which ever made it into anyone’s statistics because the DOCTORS REFUSED TO BELIEVE that fq antibiotics have any side effects to report.

    So while I think the black box warning is a good baby step, I think the FDA has lots to do to straighten this fluoroquinolone nightmare up, because it is a nightmare that no one seems to want to admit is real nor wants to deal with.

  67. rickadeemus says:

    I just found 4 “rare” side effects in my family; none of which ever made it into anyone’s statistics because the DOCTORS REFUSED TO BELIEVE that fq antibiotics have any side effects to report.

    YOU have to report it to MEDWATCH….I know that’s the FDA but if they get enough reports of ADRS to FQs then they can’t deny these drugs are doing what they do. Well…they can still deny it, but it just gets a little harder.

  68. Anonymous says:

    All of these comments on Levaquin and Cipro are very interesting and disturbing. I have taken Levaquin and Cipro more times than I can count. I always feel pretty lousy by the time I am on them that I never accounted it to the medication (chronic UTI & bronchitis). I started have sever shoulder pain about 2 years ago. Dr (and myself) never related it to the meds. I torn my calf muscle almost clear through shortly after being on Levaquin. Finanlly got a Dr. to take my arm, shoulder pain numbness in my hands and arms seriously. Have a torn rotor cuff (not a baseball player for about 20 years – never serious player anyway), torn trapazodial tendon, chronic neck pain and neuropathy. The joins in my neck (C1 thru C7) are deteriating badly. Only 40 and they haven’t been able to figure out what would cause of this to happen in such a short time frame. I have surgery to burn the nerves in my neck this coming Tuesday because I can’t the pain anymore. After we determine how much pain relief I get from that, the Dr.’s will determine if they are going to do surgery to repair the shoulder. After reading all of this, it is hard to believe all of this could be caused because of chronic infections and the medications doctors perscribe to “make it better”. Thanks for all of the good information….