FDA Warns Use of Certain Antacids May Weaken Effectiveness of Heart Drug Plavix

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The U.S. Food and Drug Adminstration (FDA) has issued a warning to users of Plavix (clopidogrel) in combination with another class of popular antacid drugs known as proton pump inhibitors like Prilosec (omeprazole) and Nexium (esomeprazole) can become weakened in their effectiveness at preventing clots and heart attacks.  According to study information, the anti-clotting benefits of Plavix are cut almost in half when taken with over-the-counter or prescription Prilosec, according to a notice posted today on the Food and Drug Administration's website,  The FDA has ordered Paris-based Sanofil and New York-based Bristol-Myers to update the prescribing information for Plavix and study the potential for other drug interactions.  In the meantime the FDA has issued the following information statement which is quoted below:

  • 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.

    Please contact the attorneys at Belsky, Weinberg and Horowitz should you have questions or concerns over prescription medication side-effects or other errors in the dispensing of pharmaceuticals. 

     

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