Information on Clopidogrel Bisulfate (marketed as Plavix)
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
Patients at 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.
1Bhatt, DL, Cryer, BL, Contant, CF, et al. Clopidogrel with or without Omeprazole in Coronary Artery Disease; NEJM, 2010; epub ahead of print.
FDA Drug Safety Communication: FDA reviews long-term antiplatelet therapy as preliminary trial data shows benefits but a higher risk of non-cardiovascular death
FDA reminder to avoid concomitant use of Plavix (clopidogrel) and omeprazole
FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug
Public Health Advisory: Updated Safety Information about a drug interaction between Clopidogrel Bisulfate (marketed as Plavix) and Omeprazole (marketed as Prilosec and Prilosec OTC)[ARCHIVED]
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)[ARCHIVED]
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)[ARCHIVED]
Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)[ARCHIVED]
Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction[ARCHIVED]