FDA says drugs may hurt effect of Plavix
WASHINGTON - US health officials said yesterday a popular variety of heartburn medications can interfere with the blood thinner Plavix, a drug taken by millions of Americans to reduce risks of heart attack and stroke.
The Food and Drug Administration said the stomach-soothing drugs Prilosec and Nexium cut in half the blood-thinning effect of Plavix, known generically as clopidogrel.
Regulators said the key ingredient in the heartburn medications blocks an enzyme the body needs to break down Plavix, muting the drug’s full effect.
Procter & Gamble’s Prilosec is the over-the-counter version of AstraZeneca’s Nexium, which was first approved in 2001.
Plavix is marketed by Sanofi-Aventis and
With global sales of $8.6 billion last year, it’s the world’s second-best selling drug behind Pfizer’s cholesterol drug Lipitor.
Because Plavix can upset the stomach, it is often prescribed with stomach acid-blocking drugs. The FDA says patients who need to reduce their acid should take drugs from the H-2 blocker family, which include Mylanta and Zantac.
FDA scientists say there is no evidence those drugs interfere with Plavix’s blood clotting.
Nexium and Prilosec are part of a class of drugs known as proton pump inhibitors, but FDA regulators said they don’t have enough information to say whether other drugs in that class shouldn’t be used with Plavix.
The FDA said the Plavix warnings have been strengthened based on a 150-patient Sanofi study.
Correction: This story in the Nation pages about drug interactions between heartburn medications and the blood thinner Plavix misidentified Johnson & Johnson's Mylanta as part of the H-2 blocker drug family. Mylanta is an antacid.