FDA NEWS RELEASE
For Immediate Release: Nov. 18, 2009
Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA Announces New Warning on Plavix: Avoid Use with Prilosec/Prilosec OTC
Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel),
the U.S. Food and Drug Administration warned on Nov. 17.
New data suggest that when patients take both Prilosec and Plavix, Plavix’s ability to block platelet aggregation (anti-clotting effect) may be
reduced by about half.
“Both of these drugs, when used properly, provide significant benefits to patients.” said Mary Ross Southworth, Pharm.D., of the Division of
Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “However, patients at risk for heart attacks or strokes
who use Plavix to prevent platelet aggregation will not get the full effect of this medicine if they are also taking Prilosec.”
Plavix is used to prevent blood clots that could lead to heart attacks or strokes in at-risk patients. Omeprazole, the active ingredient of Prilosec
and Prilosec OTC, is a proton pump inhibitor (PPI) used to reduce the production of stomach acid and prevent stomach irritation.
Plavix does not have anti-clotting effects until it is converted or metabolized into its active form with the help of the liver enzyme, CYP2C19. Prilosec
blocks this enzyme, thereby reducing the effectiveness of Plavix
Public Health Advisory: Updated Safety Information about
a drug interaction between Clopidogrel Bisulfate
(marketed as Plavix) and Omeprazole (marketed as
Prilosec and Prilosec OTC)
[11/17/2009]
The U.S. Food and Drug Administration (FDA) has new data showing that omeprazole (Prilosec/Prilosec OTC)—a medicine used to reduce
stomach acid—reduces the anti-blood clotting effect of clopidogrel (Plavix) by almost half when these two medicines are taken by the same
patient. 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. This effect is called a drug interaction and it occurs because omeprazole blocks the conversion of clopidogrel into its
active form.
Since clopidogrel can cause bleeding in the stomach, medications like omeprazole may be used in combination to reduce the production of stomach
acid, and prevent stomach bleeding. Omeprazole is available by prescription and as an over-the-counter (OTC) medication to treat frequent heartburn
FDA wants to emphasize the following information for patients using clopidogrel:
- Patients using clopidogrel should 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
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. However, Tagamet and Tagamet HB (cimetidine) should not be used. Ranitidine and famotidine are available by
prescription and OTC and antacids are available OTC.
The manufacturers of clopidogrel have agreed to look at other possible drug interactions with clopidogrel. In the meantime, the clopidogrel label will
be updated with new warnings on omeprazole and other drugs that could interact with clopidogrel in the same way. When more information becomes
available, FDA will communicate any additional recommendations or conclusions on the use of clopidogrel.