The U.S. Food and Drug Administration (FDA) is reminding the public that it continues to warn
against the concomitant use of Plavix (clopidogrel) and omeprazole because the co-administration
can result in significant reductions in clopidogrel's active metabolite levels and antiplatelet
activity. This information was added to the drug label of Plavix in November 2009, and has been the
source of continued discussion in the medical literature.1
risk of heart attacks or strokes, who are given Plavix to prevent blood clots, will not get the
full anti-clotting effect if they also take omeprazole. Omeprazole is found in prescription
products (Prilosec, Zegerid, and generic products) and over-the-counter products (Prilosec OTC,
Zegerid OTC, and generic products).
FDA wishes to emphasize additional facts that may
be a source of confusion among healthcare professionals:
- With regard to the proton
pump inhibitor (PPI) drug class, this recommendation applies only to omeprazole and not to all PPIs.
Not all PPIs have the same inhibitory effect on the enzyme (CYP 2C19) that is crucial for conversion
of Plavix into its active form.
- Pantoprazole (Protonix) may be an alternative PPI for
consideration. It is a weak inhibitor of CYP2C19 and has less effect on the pharmacological
activity of Plavix than omeprazole.
For more information, see FDA's previous
Drug Safety Communication on the Plavix-omeprazole interaction.
1Bhatt, DL, Cryer, BL, Contant, CF, et al. Clopidogrel with or without Omeprazole in
Coronary Artery Disease; NEJM, 2010; epub ahead of print.