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FDA, manufacturers to conduct new studies on clopidogrel
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The FDA, Sanofi-Aventis and Bristol-Myers Squibb have partnered to initiate studies to evaluate the effectiveness of clopidogrel in certain scenarios and patients.
According to an early communication from the FDA to the manufacturers, the agency was responding to published reports suggesting that clopidogrel (Plavix) was less effective in some patients. The FDA noted that some reports singled out interactions between clopidogrel and proton pump inhibitors as an area meriting further investigation. According to study results cited in an FDA document, some proton pump inhibitors have been associated with interference in antiplatelet activity in patients receiving clopidogrel.
“The FDA is aware of published reports that clopidogrel is less effective in some patients than it is in others,” the agency said in a press release. “Differences in effectiveness may be due to genetic differences in the way the body metabolizes clopidogrel or that using certain other drugs with clopidogrel can interfere with how the body metabolizes clopidogrel.”
Sanofi-Aventis and Bristol-Myers Squibb are currently working with the FDA to initiate further study of the effects of genetic factors and other drugs on the effectiveness of clopidogrel. According to the statement, the FDA said that the duration of the studies and its analysis could take several months.
“These studies should lead to a better understanding about how to optimize the use of clopidogrel,” the FDA said. “The drug manufacturers have agreed to a timeline for completing the studies and FDA will review the new information expeditiously and will communicate its conclusions and any recommendations to the public at that time.”
The FDA recommended that practitioners should continue to prescribe clopidogrel and that patients should continue to receive clopidogrel as directed. The agency also cautioned that a reevaluation for the initiation of proton pump inhibitor use in patients receiving clopidogrel may be warranted and that patients being administered clopidogrel should consult with their health care provider if they are currently receiving a proton pump inhibitor. – by Eric Raible