FDA reviews Plavix safetyThe FDA has notified healthcare professionals that the makers of Plavix (clopidogrel bisulfate, from Bristol-Myers Squibb and sanofi-aventis) have agreed to work with the FDA to conduct studies. This will allow a better understanding and characterization of the effects of genetic factors and other drugs (especially proton pump inhibitors [PPIs]) on the effectiveness of Plavix.
The FDA is recommending that healthcare providers continue to prescribe clopidogrel and to re-evaluate the need for starting or continuing treatment with a PPI in patients taking clopidogrel.
Clopidogrel is indicated for the reduction of atherosclerotic events in: recent MI or stroke, peripheral arterial disease; non-ST-segment elevation acute coronary syndrome (unstable angina/non-Q-wave MI) or ST-segment elevation acute MI.
For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092066.htm.