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...that good news? Rickhoff isn't so sure. "I definitely feel at the mercy of the pharmaceutical companies and the FDA," she says. "It's terrible that they've scared people so much. All drugs have side effects, and some probably have much worse risks than Vioxx." Studies suggest that roughly half of Americans with chronic or recurrent pain simply do not find a good solution, and the news out of the hearings is not going to make their choices any easier. In fact, chronic pain is a leading cause of lost workdays. It costs the nation an estimated...
Those concerns were answered last week by a series of studies that showed an increased risk of heart problems in users of not just Vioxx but Celebrex and Bextra as well, and by FDA advisory panels that recommended stronger warnings for the whole class of pain relievers known as COX-2 inhibitors. "The cardiovascular problems appear to be a class effect," says Dr. Eric Topol, director of cardiovascular medicine at the Cleveland Clinic. "But the magnitude of risk does seem to differ from drug to drug." It's now up to the FDA to decide whether the dangers, which...
...FDA will be looking closely for similar risks when the next three COX-2 inhibitors in the pipeline--Merck's Arcoxia, Pfizer's Dynastat and Novartis' Prexige--come up for review in a few years. This time they hope to discover potential problems before the drugs are approved, not after. --By Alice Park
Like any government agency that has been around for almost a century, the U.S. Food and Drug Administration (FDA) has endured its share of rough patches. But "rough patch" hardly begins to describe all the bad news that has battered the agency over the past few months, from the possible suicide risks with antidepressants like Prozac, Paxil and Zoloft to the cardiac risks of pain-killers like Vioxx, Celebrex and Bextra. Americans depend on the FDA to carefully weigh the benefits and risks of all drugs before approving them, but the agency has had trouble lately shaking the growing perception...
...pressure for action grew so intense by last week that the FDA was forced to take action. On the eve of an extraordinary three-day hearing to air grievances resulting from the Vioxx and Celebrex snafu, it announced plans to create a new safety board to monitor drugs for unexpected side effects that show up after the drugs have gone on sale. Meanwhile, the Bush Administration finally moved to fill a one-year power vacuum at the top of the organization by nominating its acting chief, Dr. Lester Crawford, to be the FDA's permanent head...