FDA warns of drug interaction with clopidogrel and omeprazole

The FDA has notified healthcare professionals of new safety information concerning a drug interaction between clopidogrel bisulfate (Plavix, from Bristol-Myers Squibb and sanofi-aventis), a platelet aggregation inhibitor, and omeprazole (Prilosec, from AstraZeneca; and Prilosec OTC, from Procter & Gamble), a proton pump inhibitor (PPI). Updated labeling for clopidogrel will contain new data that show the effectiveness of clopidogrel to be reduced when clopidogrel and omeprazole are taken together. 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. Separating the time of administration of clopidogrel and omeprazole will not reduce this interaction.

Esomeprazole (Nexium, from AstraZeneca), a PPI that is a component of omeprazole, should also be avoided in combination with clopidogrel. Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine (Tagamet and Tagamet HB, from GlaxoSmithKline), fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. There is no evidence that other drugs that reduce stomach acid, such as most H2 blockers, including ranitidine (Zantac, from GlaxoSmithKline), famotidine (Pepcid, from Merck), nizatidine (Axid), or antacids interfere with the anti-clotting activity of clopidogrel.

For more information visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm.