Fatalities a Death Sentence for New Painkiller?

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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 2.5 million Celebrex prescriptions written in its first 13 weeks (compared with Viagra's record 2.7 million during a similar period). Analysts have predicted that these new painkillers could quickly become a $3 billion industry.

The disturbing data is drawn from the FDA's adverse events database, which routinely collects information about patient experiences with drugs from doctors, pharmacists and the drug companies themselves. As such, the reports are merely "observations that certain patients took the drug and then something happened," Gorman explains. But until the incidents are investigated, it is impossible to say whether a 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.

Our drug reporting system is a "supersensitive one, not necessarily an accurate one," says Gorman, and that is appropriate. The goal of collecting this data is to 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.