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Leading cardiologists challenge clinical importance of interaction between clopidogrel (Plavix) and omeprazole (Prilosec) and question the wisdom of the FDA alert advising AGAINST use of these drugs together
Henry I. Bussey, Pharm.D., FCCP, FAHA
March, 2010
Since ClotCare reviewed this issue in May, 2009 (see clotcare.org/clotcare/clopidogrelprotonpumpinhibitors.aspx), information has continued to accumulate on the potential of omeprazole and other drugs to inhibit the CYP 2C19 enzyme which converts clopidogrel to its active metabolite. In addition to omeprazole and exomeprazole, the FDA letter also advises against the use of cimetidine (Tagamet), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).
Although the potential interaction has been cited to result in as much as a 45% reduction in the plasma concentration of the active metabolite of clopidogrel, a posting dated November, 18, 2009 on the heart.org (theheart.org/article/1025121.do) presents the views of several leading cardiologists who disagree with the FDA's new position. Specifically, the cardiologists do not disagree with the fact that the cited drugs may reduce the conversion of clopidogrel to its active metabolite; but rather point to several articles in which use of these interacting drugs was NOT found to be related to event rates or clinical outcomes.
The letter indicated that the FDA did not have enough data to advise against the use of other proton pump inhibitors (PPIs) and further indicated that there was no evidence of an interaction with the histamine-2 (H2) blockers ranitidine (Zantac), famotidine (Pepcid), nizatidine (Axid) or antacids.
The FDA alert is available at:
www.fda.gov/Drugs/DrugSafety/
PostmarketDrugSafetyInformationforPatientsandProviders/
DrugSafetyInformationforHeathcareProfessionals/ucm190787.htm
The Heart.org posting is available at:
www.theheart.org/article/1025121.do
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