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Boxed warning added to Plavix label regarding possible reduced efficacy in certain patients
Friday, March 12 2010 | Comments
What's This?
The Food and Drug Administration added a boxed warning to the label of Bristol-Myers Squibb Co. and Sanofi-Aventis Group's antiplatelet, Plavix (clopidogrel bisulfate), cautioning of possible reduced efficacy among patients who cannot metabolize the drug to convert it to its active form.The agency said people who have reduced function of a specific liver enzyme, CYP2C19, are not able to convert Plavix to its active form. Such individuals may not receive the full antiplatelet benefit of Plavix and may remain at risk for myocardial infarction, stroke and cardiovascular death, the FDA added.
The drug already carried this warning on its label as of last May, but after reviewing more data, the FDA decided it was important to emphasize this risk by adding a boxed warning.
According to the agency, an estimated 2 percent to 14 percent of the U.S. population are poor metabolizers of the drug. Testing is available to assess CYP2C19 genotype to determine if a patient is a poor metabolizer.
The FDA advised health care professionals to consider alternative dosing of Plavix for these patients or consider using other antiplatelet drugs.
Plavix is the second-best selling drug in the world with sales of approximately $8 billion annually, but it loses patent protection in 2012, Reuters reported.
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