March 15, 2010
FDA warns of reduced Plavix efficacy in poor metabolizersThe FDA has notified healthcare professionals and patients that a Boxed Warning has been added to the Plavix (clopidogrel tablets, from Bristol-Myers Squibb and Sanofi) Prescribing Information to include information about reduced Plavix efficacy in patients who are poor metabolizers of Plavix. Healthcare professionals should be aware that patients with impaired CYP2C19 function, the primary CYP450 enzyme that activates clopidogrel to an active metabolite, are poor metabolizers of Plavix and thus, are at risk of higher cardiovascular event rates following acute coronary syndromes (ACS) or percutaneous coronary intervention (PCI). Alternative anti-platelet medications or dosing strategies should be considered in these patients.
Plavix, a platelet aggregation inhibitor, is indicated for the reduction of atherosclerotic events in recent myocardial infarction (MI), stroke, or peripheral arterial disease, and non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) or ST-segment elevation acute MI.
For more information call (800) 446-6267 or visit www.plavix.com.