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?

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.

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).

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

@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.

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

@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]

@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?

@azntg:

See: every article about academic cheating.

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

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.

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.

@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?"

That's just disturbing

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.

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.

@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!!"

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:

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

[www.askapatient.com]

Oops, forgot the link.

@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.

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:(

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!!!!

@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.

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?"

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 ).

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.

@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....

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.

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]

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.

@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.

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.

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.

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

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.

@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.

@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.

@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.

*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.

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.

@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

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

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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

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.

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!

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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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

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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.