Safety Alerts & Recalls

What does this mean?

Since clopidogrel (Plavix) can cause bleeding in the stomach, medications like omeprazole (Prilosec, Prilosec OTC) may be used in combination to reduce the production of stomach acid, and prevent stomach bleeding. 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 ranitidine (Zantac), famotidine (Pepcid), or nizatidine (Axid) because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel. However, cimetidine (Tagamet and Tagamet HB) should not be used. Ranitidine and famotidine are available by prescription and and over-the-counter (OTC) and antacids are available OTC.

The FDA wants to emphasize the following information for patients using clopidogrel:

1) Patients using clopidogrel should consult with their healthcare provider if they are currently taking or considering taking omeprazole, including the brand name products Prilosec and Prilosec OTC.

2) 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.

3) 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.

Since there are several other drugs that may interact with clopidogrel, at your next appointment please ask your doctor to review your medication list in order to identify and manage any potential drug interactions.

Updated Safety Information About A Drug Interaction Between Clopidogrel (Plavix) and Omeprazole (Prilosec, Prilosec OTC)

As a follow up to the January 2009 Early Communication, the FDA has new data showing that the heartburn medicine omeprazole (Prilosec, Prilosec OTC) reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medications are taken by the same patient. Patients who use clopidogrel to prevent blood clots and reduce the risk for heart attacks or strokes will not get the full benefit of this medicine if they are also taking omeprazole.

The FDA is recommending that omeprazole be avoided in combination with clopidogrel. Other drugs expected to have a similar effect on clopidogrel should also be avoided, including esomeprazole (Nexium), cimetidine (Tagamet), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFend), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), and ticlopidine (Ticlid).

At this time, it is unknown to what extent other proton pump inhibitor (PPI) heartburn medicines may interfere with clopidogrel. Other PPI heartburn medicines include deslansoprazole (Kapidex), lansoprazole (Prevacid), pantoprazole (Protonix), and rabeprazole (Aciphex). The manufacturers of clopidogrel have agreed to look at other possible drug interactions with clopidogrel. When more information becomes available, the FDA will communicate any additional recommendations or conclusions on the use of clopidogrel.

For more information, please visit: more information here

Source: FDA
Publication Date: 2009-11-17
Last Updated: 2009-12-05

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