FDA Drug Safety Communication

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FDA Date: 11/17/09

Plavix (clopidogrel bisulfate) FDA Drug Safety Communication

Follow-Up to the January 26, 2009, Early Communication about an Ongoing Safety Review of Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)

FDA is recommending that the co-administration of clopidogrel (Plavix), a drug used to prevent blood clot formation, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid, be avoided because omeprazole reduces the effectiveness of clopidogrel. The new recommendations, updated from a January 2009 Early Communication, are based on study results from the manufacturers of clopidogrel.

Patients who are at risk for heart attacks or strokes may not get the full protective anti-clotting effect if they are using clopidogrel and omeprazole together. Until further information is available, FDA recommends the following:

- Avoid using omeprazole and clopidogrel together and at any time of the day. Separating the dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

- Avoid using other potent CYP 2C19 inhibitors, including esomeprazole, with clopidogrel.

- At this time, FDA does not have enough information about drug interactions between clopidogrel and PPIs other than omeprazole and esomeprazole to advise on their use together.

- Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids and most H2 blockers such as Zantac (ranitidine), Pepcid (famotidine), Axid (nizatidine), but not Tagamet and Tagamet HB (cimetidine).

View the full FDA Drug Safety Communication on FDA.gov