| FDA Issues Warning on Combining Clopidogrel with GERD Drug |
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| Posted by Dr. Johanne Perez M.D |
| Wednesday, 18 November 2009 16:40 |
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WASHINGTON -- The FDA is advising physicians to avoid concomitant use of omeprazole (Prilosec) and clopidogrel (Plavix) because of possible blunting of anti-clotting activity. By Peggy Peck, Executive Editor, MedPage Today Published: November 17, 2009
The decision to require a change to the clopidogrel label warning of the interaction was based on the agency's analysis of new data from drugmaker sanofi aventis, Mary Ross Southworth, PharmD, a deputy director of the FDA's Center for Drug Evaluation and Research said in a press conference. She said lab tests from 150 healthy volunteers provided evidence that omeprazole, which inhibits CYP2C19, "reduces the pharmacological activity of [clopidogrel] if given concomitantly or if given 12 hours apart." The FDA said the drugmaker conducted the as-yet-unpublished study at the request of the FDA. The label change states that "there is no evidence that other drugs that reduce stomach acid, such as most H2 blockers (except cimetidine, which is a CYP2C19 inhibitor) or antacids interfere with the antiplatelet activity of clopidogrel." Concerns about the combination of clopidogrel and omeprazole had been building since last spring, but two recent reports -- one at the European Society of Cardiology meeting and another at the Transcatheter Cardiovascular Therapeutics meeting in late September -- suggested that those concerns were overstated. Against that background, the FDA announcement struck many as odd, especially since many cardiologists are focused on digesting research being reported here at the American Heart Association. But the label change was discovered by one blog, CARDIOBRIEF.org, which reported the new label language yesterday. Although not included in the label change, the FDA said the following drugs -- which are also CYP2C19 inhibitors -- should also not be used in combination with clopidogrel: esomeprazole (Nexium), cimetidine (which is available by prescription as 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). In its public health advisory, the FDA suggested that patients who need an acid reducer should switch to "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 anticlotting activity of clopidogrel." The FDA said it is still reviewing the results of the 3,600 patient COGENT study, which was reported at the TCT meeting, but Southworth indicated that the agency was not impressed with those findings. |
ORLANDO -- The FDA has issued a public health advisory warning patients and physicians that concomitant use of clopidogrel (Plavix) and omeprazole (Prilosec and Prilosec OTC) blunts the antiplatelet effect of clopidogrel, thus increasing the risk of myocardial infarction and stroke.