FDA Warns of Dangerous Drug Interactions for Clopidogrel (Plavix) Patients

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Posted by Paul NapoliNovember 17, 2009 4:56 PM

November 17, 2009

The U.S. Food and Drug Administration (FDA) released a public health advisory today warning the public of the dangerous drug interaction between clopidogrel (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC).

Clopidogrel is an anti-clotting medication prescribed for patients at risk for heart attacks or strokes. It may also cause bleeding in the stomach and medications like omeprazole may be used in combination with clopidogrel to reduce the production of stomach acid and prevent stomach bleeding. The FDA has new data showing that omeprazole, when used in conjunction with clopidogrel, reduces the anti-blood clotting effects by blocking the conversion of clopidogrel into its active form.

The FDA warns patients using clopidogrel to consult with their healthcare provider if they are currently taking or considering taking omeprazole, including Prilosec OTC. Both clopidogrel and omeprazole can provide significant benefits to patients, and patients should always consult with their healthcare professional before starting or stopping any medication. It is very important that patients talk with their healthcare professional about any over-the-counter (OTC) drugs they are taking before starting or while using clopidogrel.

The FDA advised in the agency’s Drug Safety Information for Healthcare Professionals, “The concomitant use of omeprazole and clopidogrel should be avoided because of the effect on clopidogrel's active metabolite levels and anti-clotting activity.”

Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids such as Maalox or Mylanta and most acid reducers, such as Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine), because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel.

The FDA warned that these other drugs should also be avoided in combination with clopidogrel because they may have a similar interaction include: esomeprazole (Nexium), cimetidine (which is available by prescription Tagamet and OTC as Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).

If you or a loved one has suffered a dangerous drug interaction or harmful side effects of over-the-counter or prescription medication, contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages and pain and suffering.

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