FDA reviews Plavix safety

The FDA has notified healthcareprofessionals 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 ofgenetic factors and other drugs (especially proton pump inhibitors [PPIs]) onthe effectiveness of Plavix.

The FDA is recommending thathealthcare providers continue to prescribe clopidogrel and to re-evaluate theneed for starting or continuing treatment with a PPI in patients takingclopidogrel.

Clopidogrel is indicated for thereduction of atherosclerotic events in: recent MI or stroke, peripheral arterialdisease; non-ST-segment elevation acute coronary syndrome (unstableangina/non-Q-wave MI) or ST-segment elevation acute MI.

Formore information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm092066.htm.