Summary

Original source:
http://www.reuters.com/newsArticle.jhtml;jsessionid=HAAISERAKVX4MCRBAEOCFFA?type=healthNews&storyID=7666545

Details

• A pain reliever called Mobic has shown a higher risk of heart attacks in early data than found with Merck & Co. Inc.'s now-withdrawn Vioxx, a veteran U.S. Food and Drug Administration scientist told an FDA advisory panel on Thursday.
• The drug, made by privately-held Boehringer Ingelheim Pharmaceuticals, showed the effect in a new, yet-to-be published study, said David Graham, associate director for science and medicine at the FDA's Office of Drug Safety.
• Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx, and any possible heart attack risk is important as more patients take the drug, Graham said.
• "You now have a shift in the marketplace," he told the FDA panel of outside experts, which is meeting to discuss whether pain drugs like Pfizer Inc.'s Celebrex and Bextra should remain on the market.
• Graham, along with other scientists outside the FDA, analyzed data culled from California's Medicaid program of more than 15,000 heart attack patients, making it the largest study to date on such risks.
• "We've taken a look at our post-marketing data and see nothing to indicate excessive cardiovascular risk," the company spokesman said.
• Celebrex, Bextra and Vioxx, are part of a class called Cox-2 inhibitors -- a newer type of non-steroidal anti-inflammatory drug (NSAID) thought to be safer on the stomach.
• But some recent studies have shown they can cause a higher risk of heart attack and stroke.
• Mobic is classified as a Cox-2 in some countries but is not considered part of that group in the United States, where is its only classified as part of the larger NSAID class, a Boehringer spokesman said.
• Aspirin, naproxen and other NSAIDs can cause ulcers and dangerous bleeding.

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