FDA Takes a Closer Look at Plavix After Negative Study Results

The popular blood-thinning drug Plavix is going back under the microscope at the Food and Drug Administration after several studies have shown that the drug is not as effective in some patients as it is in others.

The FDA suspects the differences in how Plavix works in certain patients depends on the genetic makeup of the patients, interactions with other drugs the patients are taking, and other factors. The agency has ordered the drug makers to conduct additional studies to examine the differences. A timeline for when those studies will be completed was not announced.

Plavix, also known by its generic name, clopidogrel bisulfate, is made by Sanofi-Aventis SA and Bristol-Myers Squibb Co. The drug is commonly prescribed to treat coronary artery disease, peripheral vascular disease, and cerebrovascular disease. It has soared to blockbuster status, having earned $4.1 billion in the first nine months of 2008 alone. However, generic forms of the drug are expected to flood onto the market in 2011, when the drug loses its patent protections.

Plavix is an antiplatelet drug that aims to reduce the risk of dangerous blood clots that may cause heart attacks and strokes. In order to work, it must first be metabolized by the body, so the way a patient’s body metabolizes the drug is a key factor in determining how effective the drug will be, the FDA said.

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