FDA Drug Safety Communication

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FDA Date: 11/17/09

Plavix (clopidogrel bisulfate) FDA Drug Safety Communication

Information for Healthcare Professionals: Update to the Labeling of Clopidogrel Bisulfate (marketed as Plavix) to Alert Healthcare Professionals about a Drug Interaction with Omeprazole (marketed as Prilosec and Prilosec OTC)

FDA is alerting the public to new safety information concerning an interaction between clopidogrel (Plavix), an anticlotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid. New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. Patients at risk for heart attacks or strokes who use clopidogrel to prevent blood clots will not get the full effect of this medicine if they are also taking omeprazole. The updated label for clopidogrel will contain details of new studies submitted by Sanofi-Aventis and Bristol-Myers Squibb, the manufacturer of Plavix (clopidogrel).

FDA will continue to investigate other drug interactions with clopidogrel. The Agency will communicate any further recommendations or conclusions once additional information is available.

View the full FDA Drug Safety Communication on FDA.gov