Mobic (Generic: Meloxicam) carries a greater risk of heart attacks in early data than found with Merck & Co.’s Vioxx, a veteran U.S. Food and Drug Administration scientist told an FDA advisory panel. The drug, manufactured by Boehringer Ingelheim Pharmaceuticals, exhibited the effect in a new study that has yet to be published, said David Graham, associate director for science and medicine at the FDA’s Office of Drug Safety.
We found an increased risk, Graham said. It’s one study. It’s the only study. Mobic has become the top-selling prescription pain drug since Merck pulled Vioxx in September 2004, and any possible heart attack risk is important as more patients take the drug, Graham said. Graham, along with other scientists outside the FDA, analyzed data from California’s Medicaid program of more than 15,000 heart attack patients, making it the largest study to date on such risks. They found the statistical risk of heart attack was 1.37 for Mobic, compared to 1.32 with Vioxx and 1.09 with Celebrex.
Celebrex, Bextra and Vioxx, are part of a class called Cox-2 inhibitors, a newer type of non-steroidal anti-inflammatory drug (NSAID). Mobic is classified as a Cox-2 in some countries but is not considered part of that group in the United States, where it’s only classified as part of the larger NSAID class. Abbott Laboratories, which co-markets Mobic in the United States, said it expects U.S. sales of the drug to hit $1 billion in 2005.
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