Plavix warning may not be necessary
December 27th, 2011
06:07 PM ET

Plavix warning may not be necessary

The popular blood-thinner Plavix is a safe and effective medication for patients, including those deemed to be "poor metabolizers" of the drug, says an analysis released today in the Journal of the American Medical Association.

The findings contradict the 2010 boxed warning that the Food and Drug Administration mandated be placed on the drug's label.

If you're one of the approximately 40 million people worldwide taking Plavix (known generically as clopidogrel), you're probably familiar with the warning. The label cautions that the drug has "diminished effectiveness in poor metabolizers", or patients with a certain genotype, known as CYP2C19, and thus may lead to an increase in cardiovascular events like heart disease, stroke, or bleeding. To help decide if Plavix is a good fit for patients, the label says genetic tests are available to identify people with the genotype in question.

Yet in the analysis published today, researchers looked at 32 individual studies, involving more than 42,000 patients, and concluded that Plavix works well in patients both with and without the genotype. They found no significant increase in cardiovascular events in patients with the genotype who took Plavix.

"The drug Plavix itself is not active, it has to be metabolized in order to become activated," explains Dr. Steven Nissen, with the Department of Cardiovascular Medicine at The Cleveland Clinic. The liver enzyme CYP2C19 is what activates the drug.

"If you're a slow metabolizer theoretically you might not produce enough active drug to get the anti-coagulant effect of Plavix and that's why all of this from a theoretical point of view made sense but the problem is that theory is one thing but reality is another."

Dr. Nissen was not affiliated with the analysis but did write an editorial accompanying its publication. He believes that the FDA jumped the gun in mandating the boxed warning.

"FDA acted prematurely in putting a warning on the drug without the level of evidence that we would consider to be adequate for most standards," says Dr. Nissen.

"They were trying to do the right thing but if you look at it in the most rigorous fashion, it wasn't the right answer and it's now time to rethink it."

Dr. Eric J. Topol, the Chief Academic Officer of Scripps Health and a practicing cardiologist, disagrees with Dr. Nissen and the conclusion of the meta-analysis.

According to Dr. Topol, previous studies have found only that patients with stents would benefit from genetic testing to determine if Plavix is an appropriate drug. He believes the FDA's recommendation for certain patients to be tested for the genotype CYP2C19 remains valid.

"Patients who get stented should have the genotype test to see if they're going to respond," says Dr. Topol, who was also not affiliated with the analysis.

If patients with stents have the gene, and Plavix does not work effectively for them, "they're vulnerable to clotting their stent and if a person clots their stent, they'll either die or have a heart attack," says Dr. Topol.

"You don't want to be walking around with a stent and have this vulnerability."

In a written statement to CNN, a FDA spokesperson said the agency did not have a specific comment on the analysis.

"Generally, we do not provide comments on individual studies, reports or articles. Rather, the FDA collectively reviews the literature and takes such information into account as we discuss drug safety issues and make regulatory decisions."

So what does all this mean for patients? If you're concerned about taking Plavix, talk to your doctor to learn if genetic testing is a good option for you.

soundoff (32 Responses)
  1. larry5

    It's only safe if enough money has been paid into the system to get a favorable result. The approval process does not serve the public.

    December 27, 2011 at 20:43 | Report abuse | Reply
  2. Paul

    I find it interesting that most folks that complain about the cost of drugs are those not taking any life enhancing medications. I take Plavix and it has provided me with approximately 8 years of angina free living. I also take methotrexate for RA and without it I would a near cripple. Sure drugs are expensive...but so is prolonged hospitalization.

    December 27, 2011 at 21:27 | Report abuse | Reply
    • Tom

      What people object to is the cost to Americans. If you buy from Canada the cost is much less, as they are not permitted to gouge their citizens.

      December 28, 2011 at 08:21 | Report abuse |
    • SAMBO


      December 28, 2011 at 15:00 | Report abuse |
    • Koren

      I do agree with you, but, I also have insurance. I know that if my family didn't we would be living in a box. Beyond new found medical problems for myself, my son and I have Type 1 Diabetes. Without the coverage we would be paying over $2,500 a month just to be able to live. Atleast with insurance we can squeek by with paying only $260 a month for those meds. But like you said...cheaper than a hopital stay. Or burial costs.

      December 29, 2011 at 08:58 | Report abuse |
  3. Jq Farma

    I wonder how much they paid to have the medical association say it's "safe". I also wonder how come a drug to lower cholesterol ends up with side effects such as vision loss and possible death. lol

    December 27, 2011 at 22:31 | Report abuse | Reply
  4. Al Sorensen

    Is it true Plavix is going generic in March 2012??

    December 27, 2011 at 23:43 | Report abuse | Reply
    • tsauntd

      Not March. Possibly after May 17, 2012, when the patent is currently set to expire.

      December 28, 2011 at 06:38 | Report abuse |
    • annie

      Plavex is already in the generic form in Canada.

      December 29, 2011 at 23:37 | Report abuse |
  5. RobHJr

    Whatever the trigger, Plavix nearly killed my father after he had a stent put in last year. Shortly after he started taking the medication he started bleeding internally. He remained in the hospital for 6 weeks, nearly died 3 times and had several transfusions done. The doctor refused to take him off Plavix saying it wasn't the problem, but, behold, 5 days after the Plavix was finally stopped, his internal bleeding stopped. He's been fine since. There was no official diagnosis for his 'complication'. Beware: some people do have these side-effects!

    December 28, 2011 at 09:07 | Report abuse | Reply
    • Fred

      No doctor can legally force someone to take anything against their will. Patients have the right to refuse treatment. Next time "fire" the doctor. He almost killed your dad. This happened to my spouse and she also had pulmonary edema and gastro hemoraging on Plavix. Plavix removed, problem went away.

      June 9, 2017 at 18:54 | Report abuse |
    • tom

      If plavix removed, great. But what did doctor replace it with??

      May 12, 2018 at 23:33 | Report abuse |
  6. Who paid them off?

    Who do they think they are talking to? Most of us already know that the FDA is bought and paid for by various pharmaceutical companies. They pay to fudge results and bribe them to keep it secret. The FDA will test numerous expensive drug after drug but wont bother to test the purity of a vitamin that all humans need? Ok. We know why that is..

    December 28, 2011 at 11:42 | Report abuse | Reply
  7. hamsta

    The real drug dealers are the government the doctors and the pharmacists.thats who caused columbine.they where force feeding that kid zoloft an antidepressant used to treat adhd.the insanely long list of side effects begins with suicidal and homicidal behavior.adhd is an invented disease so they can medicate instead of discipline a child who misbehaves.these same people tell ur children in school that illicit drugs dont fix anything.maybe someone needs to tell them that my neither crackhead ex girlfriend nor my ex heroine addict roommate not even my meth head neighbor shot up a school.these drugs they force down ur childs throat is more dangerous than the absolute worst of the street drugs.take it from someone who is surrounded by drug addicts.

    December 28, 2011 at 22:56 | Report abuse | Reply
  8. lowryjim@hotmail.com

    In 2001 I had a massive MI (heart attack). My right artery was one hundred percent (100%) blocked and my left artery was ninety-five percent (95%) blocked.
    The Cardiologist at a major Clearwater, Florida was able to clear the blockage and implant a stent inside each artery.
    I was told at that time by the Cardiologist (at major hosp.) I would have to take aspirin (ASA) and Plavix 75 mg, for the rest of my life.
    The VA Medical Center has had me taking Plavix 75 mg and ASA, since joining their system sometime in 2002/03.

    Then in approximately April or May of 2011, I was informed by my Primary Care Physician that I would no longer be receiving Plavix. I was not told why or given a chance to talk to a Cardiologist.

    I informed her I was told by the Cardiologist, at the major Hospital, I was to remain on Plavix for the rest of my life. I informed her of this fact several times.

    My Primary Care Physician requested a Consult with a VA Cardiologist. The Cardiologist requested her, to request that several tests be ran, before a VA Cardiologist provided a Consult.

    The tests were ran and everything came back fairly normal for my conditions. The Consultation was then assigned to a Dr. at the VA Medical Clinic.

    On July 05, 2011 I had a Heart Stress Test with Mycardial Perfusion Imaging performed. This test helps find blocked arteries to the heart muscle.

    On July 06, 2011 an entry is made into my records where it shows I am Evaluated by Cardiology at the VA and advised I will be switched to Aspirin (ASA). Again, I informed my Primary Care Physician I was told by the Cardiologist, at major Hospital, I was to remain on Plavix for the rest of my life.

    And How can I “be switched” to something I am Already taking? Is it possible someone did not throughly review my records?

    On June 08, 2011 my last prescription of Plavix (Clopidogrel Bisulfate) 75 mg is filled for ninety (90) Tablets. Meaning after ninety days I will no longer be taking Plavix. This is the medicine I am to take for the rest of my life to Prevent Blood Clots.

    As of September 08, 2011 I am no longer taking Plavix due to the VA Clinic declining to renew my prescriptions and saying I should be “switched to aspirin”. Again, how can a patient be switched to something they are already taking?

    The only change to my medical condition between July, 2011 and November 25, 2011 has been the failure of the VA to renew my prescription of Plavix.

    On November 25, 2011 I am admitted to Gulf Coast Medical Center for Acute Coronary Syndrome.

    When I told the Dr., that the VA refused to renew my prescription of Plavix, he was aghast. And the Dr. made “Of Note” this discontinuation in his initial assessment.

    During this initial assessment the Dr. recommended proceeding with cardiac catheterization and that I be taken urgently to the cardiac catheterization lab.

    It was found that my right artery was one hundred percent (100%) blocked. An artery that according to the VA was fine just months prior. And had been fine for the past ten (10) years, until being removed from Plavix.

    After clearing the clotted artery and three (3) stents were implanted, the Dr. provided a “PLAN”; whereby, I was loaded with six hundred (600) mg and stated I will continue Plavix 75 mg daily indefinitely and that I will also continue aspirin (ASA) 325 mg daily indefinitely.

    It is said through many studies and reports, people who are treated with a stent, and stop taking Plavix, have a higher risk of getting a blood clot on the stent. In fact it is said “the Risk of Death or Heart Attack May Be Higher in 3 Months After Stopping Plavix”.
    Plavix is used alone or with aspirin to lower my chance of having another serious problem with my heart, such as a blood clot that can lead to death.
    Due to my family and medical history, stopping Plavix increased my risk, of having my artery clot and ;thereby, producing a heart attack or stroke.
    When the VA Dr. did not renew my prescription, I was never provided an opportunity to ask him any questions regarding his reasons behind his decision not to continue me on PLAVIX.
    So the questions remain;

    1) Who issued the original Directive or Order to discontinue my Plavix prescription in the first place, bringing about the requested Consult. Why was a Directive or Order issued? And how many Veterans does it affect.

    2) Why was I taken off of Plavix when my history showed I should remain on the medication, as there were also No adverse signs (such as blood in stool or other excess bleeding) indicating I should be removed from Plavix. And as most studies conclude, it is much better to keep taking the medicine to prevent a stent from clotting than to stop taking the medicine.

    3) Is the VA, knowledgeable enough to fully understand the studies as they relate to Plavix and a patients history? Or could there be some form of financial motive, as in reducing cost.

    4) Was the VA Dr., derelict in the performance of his duties? As it appears he did not take the time to fully review my medical history; otherwise, he would have know I was Already taking 325 mg of ASA, when he stated I be taken off of Plavix and “switched to ASA”. Has he done (or is doing) this to other Veterans?

    5) I am taking Plavix for ten (10) plus years with NO problems, why take the chance and change. Why change something, that tests show is working? What is the old saying, If it isn’t broken Don’t fit it.

    December 29, 2011 at 08:23 | Report abuse | Reply
    • Donna

      Sir, I have been taking Plavix since 2005. I am wondering how you are doing today? Hope all is well now.

      June 25, 2013 at 09:19 | Report abuse |
  9. hamsta

    @lowryjim-those are the death panels that bill oreally glenn beck and rush limbaugh where talking about.u dont have the right to take those valuable resources from the welfare junkies even though u earned that right and they didnt.that is the health rationioning with their eyes open that obamas health czar was talking about.there is more than one definition of czar and they are starting to resemble the communist dictator version of that definition.maybe next time one of those peoplethat obama and his socialist elite like to call right wing extremists speak u might want to listen cuz they have a pretty good track record of being proven correct.thank u for ur time in the in the service.its people like u who fight for my freedom.i think its sad my government would take away ur right to live and give it to welare junkies and illegal immigrants.obama calls this redistribution of wealth.i call it special rights for moochers.

    December 29, 2011 at 10:07 | Report abuse | Reply
  10. hamsta

    my methhead neighbor died of a drug overdose.u know what killed him?aspirin.he had tmj.its some kind of problem with the jaw that causes pain and headaches.he was prescribed hydrocodone but nearly died of an overdose from that.so he switched to aspirin and died from an overdose from that..moral of the story-sometimes death is the only thing that will cure someones addiction.aspirin isnt addictive but can be just as deadly if u take to much.can be just as deadly.almost dieing cured his addiction and watching him die from something nonaddictive scared my roommate straight.he quit on his own cold turkey two years ago.something both of t them told me-the most addictive drugs are pharmasuedicals and tobacco.i believe them cuz they both beet addictions to numerous substances but none of us can quit cigarettes.thanks joe camel ur so cool.

    December 29, 2011 at 11:55 | Report abuse | Reply

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    December 29, 2011 at 14:21 | Report abuse | Reply
  12. RobertC

    Why not just let the AMA and university research labs evaluate drugs and get rid of the FDA completely? It is a useless bureaucratic monster that costs American taxpayers billions of dollars and obstructs healthcare progress.

    December 29, 2011 at 21:47 | Report abuse | Reply
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