Effient: FDA May Approve Blood Thinner That Causes Internal Bleeding

The Food and Drug Administration may be on the verge of approving an ELil Lilly blood thinner a consumer group says causes internal bleeding.

The drug in question is prasugrel (to be advertised as Effient), which watchdog Public Citizen and Johns Hopkins research director Dr. Victor Serebruany say wasn’t tested at a proper dosage by Lilly. The result, Public Citizen argues, is an unsafe drug potentially harmful in the long term may be released to the public.

This is a high-stakes issue because the drug, as a competitor to Plavix, could earn Lilly a billion dollars a year, an Associated Press story says.

The drug prevents more heart attacks than Plavix, but it also causes more internal bleeding, according to a study of over 13,000 patients conducted by Lilly.

But consumer watchdog Public Citizen says that study did not give an accurate comparison of prasugrel versus Plavix.

In a letter Wednesday, the group notes that the dose of prasugrel studied by Lilly was about 2.5 times more potent than the dose of Plavix. The scientists say that the higher dose accounted for the excess bleeding seen with prasugrel. The letter said some patients on prasugrel actually stopped forming blood-clotting platelets completely, putting them at increased risk of hemorrhages.

The story says a panel of outside advisers recommends the FDA approve the drug, because it cured 24 heart-related problems for every 10 cases of bleeding it caused. The department is mulling things over and has already missed two target dates for the drug’s review.

Consumer group wants halt on review of Lilly drug [AP]
(Photo:largeprime)

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  1. Jim Topoleski says:

    Dont all blood thinners cause internal bleeding in rare cases though?

    I am pretty sure all the ones I have seen give that as a possible side effect, even Plavix.

    • nataku8_e30 says:

      @Jim Topoleski: Yeah, I was also under that impression. You can’t really thin blood without reducing the body’s ability to clot and increasing the chances of internal bleeding.

      • MinorAnnoyance says:

        @nataku83: I suffer from internal bleeding and consistently low blood counts and all I take is my normal aspirin regimen as far as thinners are concerned.

    • floraposte says:

      @Jim Topoleski: Right, but how much internal bleeding? If it’s 90% of people bleeding out to the point of hospitalization, that’s different than .2% have a little blood in their urine but otherwise being fine.

    • chiieddy says:

      @Jim Topoleski: I was once a juror on a malpractice case where blood thinners were used when a clot formed around a stent that had been put in the patient earlier in the day (this sometimes happens) and caused a heart attack in the patient. There had been a small perforation made to the artery, so when the thinners got into his system, he started bleeding out and died. There are all sorts of things that can kill you when trying to help you.

    • BytheSea says:

      @Jim Topoleski: That’s what I thought. Maybe this one is beyond reason.

    • It's not my baby, baby! says:

      @Jim Topoleski: Plavix and this drug are not “blood thinners” as incorrectly stated in the article. This class of drugs are called “platelet aggregation inhibitors” which work by lessening the clotting power of the blood, not by decreasing the relative platelet concentration.

      Blood thinners cause the patient to bleed out very quickly due to blood that evacuates the vessels quicker than the body can clot it. PAI’s cause more ‘slow bleeds’ where an innocuous leak just never stops.

      • HogwartsAlum says:

        @My father was a service droid!!!:

        When you are on blood thinners, depending on the dose, you have to be very careful. You can’t play contact sports and you should wear one of those bracelets. I had to take Coumadin for a year because I had DVT in my leg.

        One time I was at work while taking it and I went to scratch my nose and bumped it instead (not hard) and had this GUSHING nosebleed all over my shirt. It was very scary.

        • Euglenas says:

          @HogwartsAlum:

          Pssh. My whole family has gushing nosebleeds on a daily basis. You should have seen what happened when my mom tried-very briefly-Plavix or some such drug. THAT was gushing.

  2. Unsolicited Advice says:

    How about Consumer blogs allow scientists and regulators to judge a drug? Amateur activists will destroy the health of hundreds of lucky patience in their insistence that drugs carry no risk or side effects. Medication is always a utilitarian gambit where the FDA must weigh the danger of a drug with its benefit. Given the lethality of these heart issues I want less uninformed quibbling from blogs and activist doctors, please. This kind of nonsense is why the FDA exists – it’s a shame that agency has so effectively destroyed its reputation that many consumers would rather trust internet commentary.

    • Unsolicited Advice says:

      @Unsolicited Advice:

      Patients. Lucky patients.

    • Hil-fish says:

      @Unsolicited Advice: This is always my argument when I talk to people about vaccines causing autism. I will take medical advice from my doctor, not Jenny McCarthy and Jim Carrey, thank you. I’m sorry that your child is autistic, I truly am, but there is zero scientific evidence that autism is caused by vaccines. The fact that most children get lots of vaccines at the same time that signs of autism begin to appear does not imply causation.

      • edwardso says:

        @Hil-fish: I feel the same way about people who rage against anti-depressants. Maybe they don’t work for you but they get me out of bed so I’m going to keep taking them

    • HIV 2 Elway says:

      @Unsolicited Advice: Bingo! How many people have died as a result of the FDA’s reluctance to allow patents to take life saving drugs? If me or my hypothetical child has a life threatening disease, I’ll risk the unknown side-effects if there is a chance the new drug can save a life.

      • Unsolicited Advice says:

        @HIV 2 Elway:

        Part of the FDA’s responsibility is to protect you from making distressed decisions to use untested or unconventional therapies that could worsen an illness. Your argument and mine are a bit different. The FDA should be reluctant, in my opinion – but that reluctance should be trusted, and blogs should stop making hay out of drug industry FUD.

    • CrowMignon says:

      @Unsolicited Advice: So we are to stop questioning our all-knowing government? Take what they say is good for us and shut the hell up? That sounds smart.

      • Unsolicited Advice says:

        @CrowMignon:

        You know how they say that there are no stupid questions? They’re lying. “Questions” based on specious evidence can be deadly when it comes to medication. I hate to belabor the autism vaccination bit but it’s killed children, and all because some rather stupid people have found a way to publicize an influential argument that convinces some parents that vaccines are unsafe. The FDA should be trusted to consider those risks and activists should not perpetuate baseless conjecture.

        • CrowMignon says:

          @Unsolicited Advice: FDA should be trusted? Fen-Phen? Vioxx? (Celebrex?) FDA is overworked and far too easily deceived to trust them without hesitation. Do you work for a pharmaceutical corporation? Or FDA? You seem intent on protecting them from questions…

          • Unsolicited Advice says:

            @CrowMignon:

            Yes, the FDA should be trusted. I understand that failings have damaged its credibility and lamented that in my first post. All that aside, Americans require a reasonable arbiter of what is safe for Americans to consume and the FDA has repeatedly undermined its capabilities with such public failures. Even in the worst failures, though, it’s been clear that the agency made a risk judgment that was reasonable; the consistent problems appear to be in the data collection and testing phases. That is where the FDA needs to perform better.

            That doesn’t change the fact that uninformed speculation on trusted sites can create health risks.

  3. Jessica O'Dowd says:

    Yah, that is a risk with all anticoagulant. That’s why you need to report any bleeding with an unknown origin ASAP! It will probably be used for patients who can’t use aspirin, heparin, or coumadin..

    • Jessica O'Dowd says:

      @Jessica O’Dowd: Anticoagulants!

    • Trulymadlyme says:

      @Jessica O’Dowd: Yes. The main issue with blood thinners is that they require A TON of follow up by doctors and patients. That’s why heparin is pretty much only used by patients in a hospital and coumadin is followed very closely. I do worry about bad doctors not following the dosing protocols or checking the INR levels and patients not being aware that blood thinners are fairly dangerous (but often necessary) drug.

    • Eyebrows McGee (now with double the baby!) says:

      @Jessica O’Dowd: “It will probably be used for patients who can’t use aspirin, heparin, or coumadin.. “

      You’d hope, but part of the problem with Vioxx (which should have been primarily available only to patients who didn’t respond to less-serious drugs with longer histories) was that direct-to-consumer advertising and direct-to-doctor advertising made a lot of patients and doctors jump to it as a first resort instead of after trying more standard therapies first.

  4. nova3930 says:

    As far as I’m concerned, as long as the information about bleeding risk is put out there in the open, let the Dr. and their patient decide whether the risk/reward ratio is good enough to use it.

    • HiPwr says:

      @nova3930: You beat me to it. If a doctor has a patient that he evaluates at being at a very high risk to have a heart attack, it seems reasonable to prescribe this medication initially to get things under control before going to a less potent medication.

      Why take it out of the toolbox?

  5. Trulymadlyme says:

    Blood thinners are insanely dangerous, generally. I’m surprised this got approval considering that when my father was on warafin sodium, he went to the doctor four times a week to get his INR levels checked. I wonder if this drug’s use is going to be limited to people being treated as in-patients at hospitals?

    • unpolloloco says:

      @Trulymadlyme: It hasn’t yet – but it should. Blood thinners are crazy dangerous, but they prevent even more dangerous diseases. It’s a balancing act. Healthy people should not take them. However, if someone needs them, they should have access to them – it should be the doctor’s and patient’s call, not the FDA’s (when the potential benefits for some subset of the population outweigh the risks for that same subset).

      • henwy says:

        @unpolloloco:

        Lets see, some internal bleeding or massive heart attacks. Hmmm. Well I think if I have to choose I’d go with the former.

        • Trulymadlyme says:

          @henwy: No one is saying whether people should or shouldn’t be able to take it. But the safety issues of the drug militate some caution on its use outside of being in the hospital or being see by the prescribing doctor nearly 3 or 4 times a week (which is extremely cumbersome on the part of the practicing doctor.).

        • unpolloloco says:

          @henwy: Exactly. My question is: why should the FDA make that choice for you?

          • henwy says:

            @unpolloloco:

            They shouldn’t, but people are stupid. I can just see morons choosing to take this drug and then their relatives suing the company for wrongful death when they die of internal bleeding. The age of personal responsibility in our society is dead. Lawyers might have helped to kill it, but it’s John Q Public that landed the death blow.

            • Trulymadlyme says:

              @henwy: I guess everyone missed my point, which is doctors have to monitor these drugs very, very closely. Putting aside the consumer “I want this” meme, a doctor needs to understand what they must do when this drug is prescribed. See Vioxx fiasco.

              • henwy says:

                @Trulymadlyme:

                I didn’t view Vioxx as a fiasco. I took it for a while and knew (because I actually researched) the risks going in. The risks were small compared to the benefits. Even now, both it and Celebrex are still being used for that very reason despite the ridiculous hurly burly some people threw up about it.

                • Trulymadlyme says:

                  @henwy: There is absolutely nothing wrong with Vioxx except for the fact that doctors were choosing it as a first line drug (in response to massive direct and patient advertising many believe). Its benefits were marginal (if not often less) than the first generation therapies. I’m just saying that blood thinners are tricky to prescribe and dose, and many patients lack the sophistication to understand that. But doctors: another completely different story.

  6. zarex42 says:

    It’s completely unreasonable to expect a treatment to be entirely without side-effects. Medicine is an odds game – is the risk of the side effect greater than the risk of not taking the drug? Almost certainly not.

    Spinning this as profit-mongering is really out of line.

    • willdude says:

      @zarex42: Agreed. I don’t really understand what the issue is here. It’s not like there was any deception involved. The drug was tested at a certain dosage level, which had a certain level or rewards versus risk, and all this info is publicly available. If the FDA decides to approve it, then, well, they’re the FDA, and that’s their prerogative.

      What I don’t understand is the group’s argument that the study “did not give an accurate comparison of prasugrel versus Plavix”, with the former being more potent. Isn’t like that saying that comparisons of the benefits of Extra-Strength Tylenol to Regular Tylenol are inaccurate because they have different compositions?

  7. CRNewsom says:

    These types of drugs should be prescribed very cautiously due to the dangers. However, our prescription happy culture will gladly write scripts for new drugs over older, less risky alternatives due to some advertising campaign. I’m not blaming doctors 100% here, but a combination of doctors and idiots who see a commercial on TV and demand a prescription for the new drug…

    /I would like to see this drugs effecacy on masking EPO and CERA, though…

    • HiPwr says:

      @CRNewsom: I’ve always wondered about the effect of advertisement for prescription drugs. Can a patient actually “demand” that a doctor prescribes a specific drug?

      • CRNewsom says:

        @HiPwr: It happens all the time. “I want Provasic!” Of course, the doc isn’t required to prescribe the drug, but if the patient asks for the more expensive, newer drug that (supposedly) does the same thing as the old one, why does the doctor care? They are still getting the treatment, just paying more for it.

      • Eyebrows McGee (now with double the baby!) says:

        @HiPwr: Oh yes. And patients can doctor-hop if doctors won’t give them what they want.

        This is a less-serious version, but I’ve had chronic sinus infections since I was 16 years old, and I know I respond very well to amoxicillan (3x/day for 10 days, pretty much the standard treatment for sinus infections) and zithromax (the fancy Z-Pak, some doctors prefer b/c it increases patient compliance and my ob/gyn preferred in pregnancy for safety) and very, very badly to certain other antibiotics. When I go to a doctor for a sinus infection, I basically say, “I have a sinus infection and I’d like amoxicillan.” If the doctor wants to give me something else, he’d better have a damn good reason. And if he tries to prescribe something I know I react badly to (like erythromycin), I’ll go find a doctor who’ll prescribe me something NORMAL.

        (Last time I had erythromycin I ended up vomiting for six straight hours before passing out on the floor of the bathroom from exhaustion. I’m not taking that unless I’m ALREADY in the hospital, it made me SO much sicker than the original infection. It may in some situation still be appropriate for me, but not unless I’m already hospitalized because the side effects will end with me in the ER anyway. I’m always very clear with doctors about how badly I react to it, but one idiot wanted to give it to me anyway.)

        • theblackdog says:

          @Eyebrows McGee (now with more baby!): Wow, I thought I had it bad enough. I broke out in hives when I was given amoxicillin at age 2, so no more of that for me. When I was in the hospital last week, it was fun trying to find me some IV antibiotics that did not have a penicillin allergy issue.

          Your story sounds similar to how I react to some painkillers. I learned last week that Morphine and I do not get along (puking to the point of exhaustion as well) and I had a similar reaction to vicodin a few years ago.

  8. saintpetepaul says:

    Thank you Unsolicited Advice. Very well said on all counts.

  9. rpm773 says:

    Maybe a one-armed man can convince Dr Serebruany that the drug is indeed safe.

  10. humphrmi says:

    On one hand: agreed, the community of Tubes can not, and should not, affect the outcome of a review by experts. And experts will always disagree, and it boils down to a matter of risk.

    On the other hand: I value these posts as an alert to me; if I were to go to my doctor and he suggested taking Effient (assuming it gets approved), I would now have plenty of questions to ask him about the risk of internal bleeding and how he’s going to monitor that and what to do if I see signs of it…

    • Unsolicited Advice says:

      @humphrmi:

      The risk is that less credible sources enter a complicated conversation, causing patients to engage in sub-optimal behaviors that endanger their health. You need only look at the immunization crisis caused by misguided autism correlationists to realize that the danger is very real. Measles, mumps, rubella, and other diseases thought forgotten are killing kids because of celebrity activism with a grain of truth – the influence of blogs can be extremely similar. Not to say Consumerist isn’t credible, it is, but I have real concerns about the potential behavioral impact for less-critical thinkers.

      The FDA needs to be a strong, credible organization and it needs to protect Americans.

    • henwy says:

      @humphrmi:

      Maybe it’s just me but I don’t need warnings like this. Any drug I take, I make sure to look it up and do the research first. It’s not like it’s hard nowadays with the plethora of easy information. Back in the dark ages, we just had to hope and pray that our drugs were right and weren’t going to screw us over. At least nowadays we can double check. Well, some of us anyway. I don’t think it’s all that difficult to comprehend drug information but maybe it’s different for others.

    • Rectilinear Propagation says:

      On one hand: agreed, the community of Tubes can not, and should not, affect the outcome of a review by experts.

      @humphrmi: But how likely is it that it would? Does the Consumerist have that much clout that our comments would actually affect what the FDA will do? I don’t think we should worry about discussing an AP news article because the FDA might listen to use instead of the experts.

      I just don’t think that it’s a legitimate concern.

      • Unsolicited Advice says:

        @Rectilinear Propagation:

        I don’t think either of us is worried about the FDA. The problem lies with individuals who will potentially refuse a drug due to loaded headlines like “Blood Thinner Causes Internal Bleeding.” Heart disease is more likely to kill you, and that is why we take medicine, but Consumerist has elected to form the impression for readers that this drug is a dangerous killer that will bleed you out. Phil links to some pretty crappy analysis here and this story is akin to passing on an urban legend.

      • henwy says:

        @Rectilinear Propagation:

        It causes unjustified fears, slows the process, and also lets morons believe that they have a right to sue when someone does go wrong. OMG! Look! Consumerist said the drug company knew the drug was bad and that’s why my 80 year old father with the 7 previous heart attacks and the quadruple bypass died after being on the drug! SUE SUE SUE *rabble* *rabble* *rabble*

      • humphrmi says:

        @Rectilinear Propagation: Witness what others said, but also – and I’m not trying to blow smoke up our esteemed editor’s derriere, but look at some of the things they’ve accomplished up to now: the huge coverage of the AOL cancel caller, that Domino’s tainted food story, and all the calls to torches-and-pitchforks over AIG compensation that led their CEO to quit. And that’s just Consumerist, but my reference to the “Community of Tubes” was about the whole internet and the viral nature of these stories, where once one big blog picks up the story and it gets digged (dug? eh whatever) a few times, next thing you know MSNBC is calling it the “Killer Drug”.

        But also note that I made it pretty clear that it’s valid to post these sorts of stories, at least under the context of “better consumer awareness.”

  11. vladthepaler says:

    Do you mean Eli Lilly?

  12. unpolloloco says:

    This article is irresponsible and unethical of the Consumerist. It has no basis for bringing this up and jeopardizing the health of the many people that might benefit from this drug. The FDA’s decision should be uninfluenced by outside unqualified opinion. It should weigh the risks and benefits of the drug on its own merits, not what a community of people on the internet thinks.

    • CrowMignon says:

      @unpolloloco: In what way is this irresponsible or unethical? Because you say so? Because we have no right to understand the scope of testing that occurred on the drugs we take? Because we aren’t all doctors? If anything, not questioning our government’s decisions, particularly as regards health, is unethical and irresponsible.

      • Unsolicited Advice says:

        @CrowMignon:

        Asking the question “How do we answer the question of this drug’s safety based on the conflict surrounding FDA testing procedures?” doesn’t seem to be the process implied by the headline. The headline is telling me this drug is going to give me internal bleeding.

        There’s a subtle but important difference between muckraking and spreading crap around.

        • CrowMignon says:

          @Unsolicited Advice: Two simple questions: Does this drug cause internal bleeding? (Yes it can.) Might FDA approve it? (Yes they might.) So the headline is accurate. So, between ‘muckraking’ and ‘spreading crap around’, which one should we use to describe your statements here?

          • Unsolicited Advice says:

            @CrowMignon:

            You understand the point being made, but you’d rather discuss semantics. I’m not interested, and I don’t need the sentence parsed for me.

            FDA Approved Drug That Causes Permanent Impotence, by your logic, is an acceptable headline to describe Viagra. That’s all anyone needs to know about your deliberately obtuse parsing.

            • CrowMignon says:

              @Unsolicited Advice: Whereas all anyone needs to know, from your point of view, is what the government agencies tell them.

              Your objection, by your own statement, isn’t that the headline isn’t true. It’s that it may generate questions that FDA – in your opinion – shouldn’t have to deal with.

              I will stick to my original point: questioning the decisions being made on my behalf by the government is always a good idea.

              • Unsolicited Advice says:

                @CrowMignon:

                To go back to my original point – there is a real risk that such questions will cause consumers to reject a drug irrationally based on something they’ve heard or read. Public skepticism carries a cost that must be weighed against the worthiness of the questions.

                • CrowMignon says:

                  @Unsolicited Advice: I don’t see where restricting the flow of information will help at all. I think the idea is ludicrous on its face and wrong-headed in its intent. There are risks on both sides of the equation, certainly, but ignorance never solved anything.

                  • Unsolicited Advice says:

                    @CrowMignon:

                    A flow of specious information is worse than no information. Urban legend and speculation are destructive forces that lead to death and violence. Look at Jim Carrey’s spouted nonsense and the corresponding spike in child deaths from vaccinated illnsses. Look at AIDS legends in Africa. As I said, you have to weigh the value of your opinions against the potential public risks. If you or Consumerist think you’re doing the world a favor with tinfoil-hatted rants and speculation, well, you’re not.

                    • CrowMignon says:

                      @Unsolicited Advice: You give great examples for MORE communication and MORE information and MORE questioning, not less.

                      Yes, AIDS has been spread when people believe in superstitions instead of medicine. How would not talking about it have helped?

                      And yes, Jim Carrey’s autism opinions were wrong – where were the reasonable voices? Where were the scientists?

                      Aside from the Jim Carrey red herring, I would say the increase in child deaths from diseases for which vaccines exist is very closely correlated to ignorance. But that is ignorance due to a lack of information rather than too much information coming from Jim Carrey.

                    • Unsolicited Advice says:

                      @CrowMignon:

                      You misidentify the appropriate cure. Placing MORE information, unfiltered, into the public consciousness creates risks that unreasonable conclusions will be drawn. Parents are repeatedly told by their doctors and health care specialists with almost total uniformity to vaccinate their children, and yet increasing numbers refuse to due to the presence of these opinionated crusaders in various forms of media. “Reasonable voices” were everywhere on vaccination and AIDS but “unreasonable voices” still produce body counts to this day.

                      Ask around. Despite literally centuries of demonstrable risk, parents in increasing amounts are not protecting their kids from illness due to erroneous shit they read on the internet and see on TV.

                      Putting crap analysis out there gets people killed just by virtue of its existence alone, which is why I drew the superstition analogy. No matter how flawed an argument, a grain of truth or convincing spokesperson will win some converts. The simple existence and spread of unintelligent discourse, lies, correlary thinking, sensationalist headlines, etc. are deadly risks to a malleable populace given to believing pretty prose and populist personalities.

                      The solution isn’t more talking, it’s silencing the mouthy morons.

                • Odaecom says:

                  @Unsolicited Advice:
                  Or worse they might think they need a drug because they heard about it on TV.
                  People don’t ask questions of their Dr. they go to get want they “think” they need.

    • Anonymous says:

      @unpolloloco: I take Warfarin daily, and will have to take an anticoagulant for the rest of my life.

      What most people are unaware of is that Warfarin is the number one ingredient in rat poison. That fact would put modern consumer groups into a fit if it weren’t an old drug and more or less a standard form of treatment. It’s also notoriously flaky. My sister has the same condition I do, and she takes a dosage 1/3 of mine, to get the same affect. Plus, something as simple as having a large salad for lunch can completely throw off things. Those of us who are on the medication more or less permanently know all the limitations but it can be frustrating and downright dangerous.

      Considering how many people still think that immunizations cause autism, I really hope the general public cannot convince the FDA what to do. This is definitely irresponsible reporting, and this kind of scare tactic may cause people like myself to be stuck in the long term with a lot less options.

    • aaronrogier says:

      @unpolloloco:

      It might seem a little sensationalist, but I don’t think it quite crosses over into the irresponsible/unethical area. Getting this critique out earlier might help this drug into use in an appropriate environment with the caution necessary for using an anticoagulant. Measures including INRs,etc. Sure there are already other anticoagulants like plavix, lovenox, coumadin, and heparin on the market, but these drugs play lifesaving roles and having a wider portfolio of anticoagulants seems like a proposition with a lot of positive aspects.

      There are even people who want Vioxx back on the market, albeit in a more nuanced role. The biggest problems in a lot of dangerous prescription drugs cases seem to be the way drugs are marketed so zealously with an effort to push out drugs that already work well in many cases to broaden a customer population rather than increase quality of care.

  13. 2Wheelsor4: The Moto-Stig says:

    My wife has been on a blood thinner regimen for the last 5 years (she’s 26) started off with coumadin (see warfarin/rat poison) but whenever we fly, or she throws a clot, she’s got to get lovonox shots in an alcohol suspension (so it burns like a mother). Luckily, she’s found a great hematologist that’s gotten her off the rat poison, kids are out of the question though. Blood thinners are insanely dangerous to start with, because you’re countermanding what the body naturally does.

  14. PunditGuy says:

    I may never take Effient (terrible name, by the way — brings to mind “effluent”), but if it’s competition for Plavix it’s more than welcome. Plavix is expensive, and won’t be available in generic form for another three years or so.

    • Eyebrows McGee (now with double the baby!) says:

      @PunditGuy: At this point I would rather my drugs be named after their chemicals than some moronic focus-grouped trendy name that invariably reminds me of something disturbing.

  15. Shane Elliott says:

    bleeding is a known risk of all blood thinners, and it is often the job of doctors and nurses to monitor a patient’s vitals and assess the need for dosage adjustment. If you really want a heart-related drug to worry about, try digoxin. That stuff has a horribly narrow therapeutic range.

  16. 3drage says:

    I’ve been on Coumadin for many years now, internal bleeding is one of the potential problems with any anticoagulant and it all depends on how each body handles the chemical. This is no big news, and is an alternative for people who need it and can’t use other medicines.

  17. extremenachos says:

    If it cures 24 heart-related diseases for every 10 cases of bleeding, I would like stats on the severity of bleeding, but more importantly the number of incidences of people developing bleeding and still not curing the underlying heart disease.

    i wish reporters would plug all of these specific details in the last few paragraphs of their article or posting a link with the info instead of forcing readers to guess. Most people don’t know understand how 2X2 tables works in studies like this or what a confidence interval really tells you about the study design, but for those that do, it can be really helpful. But i guess that’s the downside of reporters that don’t spend their careers reporting within a specific field.

  18. Anonymous says:

    The FDA does not determine that drugs are “safe” during the approval process but only looks at whether they are effective within certain parameters. Drug companies are required to monitor the safety of a drug post marketing. That’s typically one of the conditions of drug approval. Not to mention, the FDA can only evaluate the data that a drug company submits with their NDA so in the case of drugs like Vioxx where Merck knew of the cardiovascular risk when it submitted the NDA they just didn’t submit the studies that showed increased cardio risk. We all know where that got us.

    The FDA is also largely funded by drug company money in the form of user fees that drug companies submit with an NDA. If the drug company pays for a 6 month priority review and the FDA fails to hit the target date then they have to give the drug company back their money. Considering that an FDA internal report released last year concluded that the agency was understaffed and overworked (among other things) do you really think they’re taking the time to look at the data like they should be? Just saying…

  19. Sbrools says:

    All drugs have side effects, it’s just one of the things about medicine, and, as was said earlier, it’s up to the doctor and patient to work out whether or not the benefit of the medicine is worth the risk.

    Can you imagine if this was the 1860’s? I can see it now… Headline: Bayer Tries to Exploit People For Profit!!! Bayer is seeking FDA approval for a new drug called “Aspirin”. Although it has some positive effects, it has SIDE EFFECTS!!! It is known to cause stomach bleeding, tinnitus, and causes Reye’s Syndrome in children, and some people report extended periods of bleeding after operations! OMG this drug is evil and must be stopped!!! Think of the children!!!

  20. H3ion says:

    If I’m reading the article correctly, the Public Citizen complaint is not that the drug is not effective. The complaint is that a dosage was used that was higher than the dosage for the comparative product. The FDA doesn’t determine the dosages. They only determine whether the drug is safe and effective. Obviously, doctors and their patients can adjust dosages as necessary. I think I’d err on letting the FDA get more drugs into the marketplace with appropriate dispensing instructions and warnings of side effects, and let the doctors and patients decide what they’re going to use.

  21. Anonymous says:

    The comments here are all over the map. Our institution was involved in the Triton TIMI-38 trial. Prasugrel, like clopidogrel, is not a blood thinner per se. At least not like warfarin/coumadin. It is an antiplatelet agent (a super-aspirin). The goal in cardiology has been to find a way to maximize anti-platelet activity as quickly as possible in the setting of acute coronary syndromes and after stent implantation. Maximizing antiplatlet activity improves cardiovascular outcomes and reduces the risk of stent thrombosis especially in high risk patients.

    In Triton TIMI-38, the absolute numbers of patients with major bleeding was fairly low relative to the almost 14000 patients in the trial (148 patients vs. 111 patients with clopidogrel). In subgroup analyses to address the discordance between the improved efficacy of prasugrel versus clopidogrel and the tradeoff of increased bleeding, it was found that patients with prior stroke/TIA, older age (>75), and low weight (

    My point is that consumer activist groups point fingers at certain drugs that can have significant side effects, but downplay the significant benefits that these drugs can have for many patients. It is the responsibility of the physician to tailor therapy to the patient. Prasugrel will not be right for everyone, but I believe has potential to be a potent drug in the arsenal against acute coronary syndromes.

    (Disclaimer- I am a cardiologist and I have no financial relationships with any companies).

    TRITON-TIMI 38- N Engl J Med. 2007 Nov 15;357(20):2001-15.