Plavix Side Effects Lead To Debate Over Test Subjects

March 29, 2010

Plavix Side Effects Lead to Debate Over Test Subjects

With more than 2.5 million prescriptions being handed out monthly and more than 6 billion dollars in sales annually, Plavix may be the most well known and most often used heart medication in the world. However, recent studies have shown that the drug may not be as effective for some patients as it is for others.

Plavix, scientifically known as clopidogrel, is a blood thinner that helps prevent the formation of clots by preventing blood platelets from sticking together. It has now come to light that there could be a genetic variant that will make the drug ineffective for certain patients. This has now led to a debate between medical professionals as to who should be genetically tested to determine if Plavix will work on that particular patient.

The debate was started earlier this month when the FDA introduced a new Plavix black box warning. The warning was an alert to both patients and doctors that patients who are poor metabolizers of the drug could suffer potentially life-threatening or serious injuries as their poor metabolization of the drug could render it ineffective.

A University of Maryland study in August of 2009 found that about one-third of the population has a gene variant that could reduce the effectiveness of Plavix. A reduced functioning of the liver enzyme that is what converts Plavix from inactive to active form was found in people who have a CYP2C19 variant. This means that the reduction of the risk of blood clots Plavix is supposed to provide will be virtually eliminated in these patients.

The CYP2C19 genetic variant is present in around 60 percent of Asian people, and 30 percent of African Americans and Caucasians. About 2 to 4 percent of the population has two copies of this genetic variation, making this type of patient an especially poor Plavix metabolizer. The debate among many doctors lies in whether those who have only one variation of the gene variation are affected differently than those with two variations.

A study by Brigham and Women’s Hospital in 2008 found that there was a 53 percent increase in the risk of suffering a heart attack for those patients who had one copy of the gene variation who were using Plavix. It was also found that these types of patients also suffered three times as many blood clots as patients who did not carry this gene variation.

The debate among doctors continues as they are still not sure who should be tested for the variant, or even if the tests will be effective. They are also taking into consideration the possibility that patients who have the CYP2C19 gene variation may be able to overcome the current Plavix dilemma by increasing the dosage for these patients. The identification of patients who are poor Plavix metabolizers is important as their risk against possible side effects, such as increased risk of strokes and heart attacks, ulcers, and gastrointestinal bleeding, can be more readily prevented.

If you or a loved one has experienced health complications caused while taking Plavix or similar medications, contact Newsome Law Firm and fill out a case evaluation form today. Our team of attorneys has experience specific to complications associated with prescription drugs. Not only can they give you the legal guidance you need, they can help you get the compensation you deserve.

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