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The FDA has added a boxed warning to the clopidogrel (Plavix) label to alert healthcare providers that some patients (roughly 2% to 14% of the population) do not metabolize the drug effectively and therefore might not receive its full benefits.
Metabolism of clopidogrel largely depends on which alleles patients carry for the liver enzyme CYP2C19. The new warning notes that tests are available to determine a patient's CYP2C19 genotype, which can help guide treatment decisions. Clinicians are advised to consider "alternative" dosing strategies or other antiplatelet drugs for patients identified as "poor metabolizers."
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LINK(S):
FDA MedWatch alert (Free)
FDA safety communication (Free)
Clopidogrel prescribing information (Free)
Previous Physician's First Watch coverage of FDA probe into factors affecting clopidogrel response (Free)