Clopidogrel Marketed as Plavix FDA Issues Public Health Advisory

Washington, DC: The U.S. Food and Drug Administration (FDA) has new data showing that omeprazole (Prilosec/Prilosec OTC)—a medicine used to reduce stomach acid—reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medicines are taken by the same patient.

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. This effect is called a drug interaction and it occurs because omeprazole blocks the conversion of clopidogrel into its active form.

Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids (such as Maalox or Mylanta) and most acid reducers, such as Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine) because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel. However, Tagamet and Tagamet HB (cimetidine) should not be used. Ranitidine and famotidine are available by prescription and OTC and antacids are available OTC.

The manufacturers of clopidogrel have agreed to look at other possible drug interactions with clopidogrel. In the meantime, the clopidogrel label will be updated with new warnings on omeprazole and other drugs that could interact with clopidogrel in the same way. When more information becomes available, FDA will communicate any additional recommendations or conclusions on the use of clopidogrel.

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Published on Nov-17-09