Word: celebrex
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PAIN-KILLER PROBLEM The superaspirin Celebrex, touted as a potent but easy-on-the-stomach pain-killer for arthritis, may be linked to 10 deaths and 11 cases of gastrointestinal hemorrhages, according to the Wall Street Journal. What's more, five of the deaths may have been due to gastrointestinal bleeding. Monsanto, the drug's manufacturer, says there's no proof that Celebrex actually caused any deaths. Plenty of folks use the drug: 2.5 million prescriptions have been written since it was introduced in January...
Reports that the mega-successful new painkiller Celebrex has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhage during its first three months should not lead to any hasty conclusions, warns TIME medical columnist Christine Gorman. So far, it is unclear how the new data on deaths and severe reactions, first reported in the Wall Street Journal on Tuesday, is related to the drug, or whether other factors may be involved. Celebrex, the first of a new class of Cox-2 inhibitors to hit the U.S. market, has taken off nearly as explosively as Viagra did, with some...
...given reaction was caused by the drug or by other factors. The complications may have been precipitated, for example, by a patient's other medicines, illnesses or conditions, and may have nothing to do with the drug. In the case of such a widely disseminated drug, misuse of Celebrex may also be a factor...
...raise any red flags early to focus further investigation and research in case patients are experiencing problems with a drug. However, "what is interesting in this case," Gorman notes, "is that what is being reported is exactly what is not supposed to happen with this drug." Since Celebrex was expected to cause fewer stomach problems than some other painkillers, the suggestion that it may be causing severe gastrointestinal reactions is surprising...
Tell that to Dr. Philip Needham, father of the cox-2 inhibitor, who calls the white paper Palmer presented to the FDA panel "a predictable effort to protect their drug." If you want evidence that Celebrex works, he says, just ask the 13,000 arthritis patients who took part in its trial. "We're getting letters saying, 'Please don't take us off,'" Needham says. And the side effects? Pretty close to placebo levels...