Prilosec Interferes With Plavix Blood-Clotting Effect, FDA Warns
The Food and Drug Administration is warning patients who take Prilosec or Prilosec OTC to reduce stomach acid at the same time they are taking Plavix to prevent blood clots about a potentially serious adverse drug interaction between the two products.
Patients at risk of heart attack or stroke who take Plavix (clopidogrel) will not get the full effect of the drug if they also are taking a Prilosec product (omeprazole), the FDA said.
“This effect is called a drug interaction and it occurs because omeprazole blocks the conversion of clopidogrel into its active form,” said an FDA warning issued today.
Because Plavix may cause bleeding in the stomach, many patients also take Prilosec in either prescription or over-the-counter form to reduce the production of stomach acid and reduce the risks of stomach bleeding, officials said.
However, the FDA said it has new data showing that taking both drugs can reduce the effects of Plavix and put patients at increased risk of heart attack and stroke caused by blood clots. Makers of clopidogrel have agreed to further investigate the adverse drug interactions, the FDA said. Also, the labeling on Prilosec (clopidogrel) will be updated to warn of the potential for interactions with Plavix (omeprazole).
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, the FDA said.
FDA Issues Safety Guidelines
The FDA has issued the following guidelines for physicians and patients taking both Prilosec and Plavix:
• 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 drugs they are taking before starting or while using clopidogrel.
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