FDA MedWatch - Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction

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Title: FDA MedWatch - Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Audience: Cardiovascular healthcare professionals, pharmacists

[Posted 11/17/2009] FDA notified healthcare professionals of new safety information concerning an interaction between clopidogrel (Plavix), an anti-clotting medication, and omeprazole (Prilosec/Prilosec OTC), a proton pump inhibitor (PPI) used to reduce stomach acid.  New data show that when clopidogrel and omeprazole are taken together, the effectiveness of clopidogrel is reduced. 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 dose of clopidogrel and omeprazole in time will not reduce this drug interaction.

Other drugs that are expected to have a similar effect and should be avoided in combination with clopidogrel include: cimetidine, fluconazole, ketoconazole, voriconazole, etravirine, felbamate, fluoxetine, fluvoxamine, and ticlopidine. 

Recommendations for healthcare professionals are provided in the "Information for Healthcare Professionals" sheet.

Read the MedWatch safety summary, including links to the FDA Information for Healthcare Professionals sheet, Public Health Advisory, and Follow-up to the January 26, 2009 Early Communication, at:

 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm


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