faded glory polo Plavix warning may not be necessary
The popular blood thinner Plavix is a safe and effective medication for patients, including those deemed to be metabolizers of the drug, says an analysis released today in the Journal of the American Medical Association.
If you one of the approximately 40 million people worldwide taking Plavix(known generically as clopidogrel), you probably familiar with the warning. The label cautions that the drug has 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 Plavixworks 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.
drug Plavixitself 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.
you a slow metabolizertheoretically you might not produce enough active drug to get the anti coagulant effect of Plavix and that 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. 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.
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.
were trying to do the right thing but if you look at it in the most rigorous fashion, it wasn the right answer and it now time to rethink it. 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 Plavixis an appropriate drug. He believes the FDA recommendation for certain patients to be tested for the genotype CYP2C19 remains valid.
who get stentedshould have the genotype test to see if they going to respond, says Dr. Topol, who was also not affiliated with the analysis.
If patients with stents have the gene,
and Plavixdoes not work effectively for them, vulnerable to clotting their stent and if a person clots their stent, they either die or have a heart attack, says Dr. Topol.
don want to be walking around with a stent and have this vulnerability. a written statement to CNN, a FDA spokesperson said the agency did not have a specific comment on the analysis.
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. what does all this mean for patients? If you concerned about taking Plavix, talk to your doctor to learn if genetic testing is a good option for you.
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 the problem, but, behold, 5 days after the Plavix was finally stopped, his internal bleeding stopped. He been fine since.
December 28, 2011 at 22:56
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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.