The 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.