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FDA adds boxed warning to clopidogrel
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The FDA has added a boxed warning to clopidogrel (Plavix; Sanofi Aventis, Bristol Myers Squibb). The new warning is for patients who do not effectively metabolize the drug — anywhere from 2% to 14% of the population.
Although a warning about this patient population was originally added in May 2009, the FDA has decided to highlight this safety information in a boxed warning.
The boxed warning in the drug label will include information to:
- Warn about reduced effectiveness in patients who are poor metabolizers of clopidogrel. Poor metabolizers do not effectively convert clopidogrel to its active form in the body.
- Inform health care professionals that tests are available to identify genetic differences in CYP2C19 function.
- Advise health care professionals to consider use of other antiplatelet medications or alternative dosing strategies for clopidogrel in patients identified as poor metabolizers.
“We want to highlight this warning to make sure health care professionals use the best information possible to treat their patients,” said Mary Ross Southworth, PharmD, a clinical analyst in the division of cardiovascular and renal products in the FDA’s Center for Drug Evaluation and Research.
Patients should not stop taking clopidogrel unless told to do so by their health care professional.
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