Celebrex Linked to 10 Deaths
NEW YORK (AP) - 4/20/1999
Monsanto's highly successful painkiller Celebrex has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhages in its first three months on the market, The Wall Street Journal reported today.
Half of the 10 people who died suffered from gastrointestinal bleeding or ulcers, according to reports submitted to the Food and Drug Administration that were obtained by the Journal under the Freedom of Information Act. Two other deaths were attributed to heart attacks, one to drug interaction and one to kidney disorder. No cause of death was given for the 10th fatality.
The Journal did not specify the sources of the so-called adverse event reports, which could come from health professionals, consumers or the drug company itself.
Celebrex, manufactured by St. Louis-based Monsanto Co. (NYSE:MCT - news)'s G.D. Searle & Co. subsidiary, went on the market in January to treat osteoarthritis and rheumatoid arthritis.
Celebrex was touted by Monsanto as an effective pain reliever much like ibuprofen, but was much less likely to cause severe stomach problems such as bleeding ulcers.
So far it has been a gigantic success: 2.5 million prescriptions have been filled in its first 13 weeks on the market, compared with the record 2.7 million prescriptions of anti-impotency drug Viagra filled during its first three months.
Robert DeLap, director of an FDA office of drug evaluation, told the Journal that more research needs to be done before coming to a conclusion about Celebrex's safety. ``Do we think there's a signal that the product poses some special risk? No, not at the moment.''
Searle officials told the Journal they remain excited about Celebrex's performance. ``We really feel the drug is performing as expected. The safety profile is what we would expect,'' said Steve Geis, the company's vice president for arthritis clinical research.
Geis declined to go into details about any cases of death linked to the drug, but said that many patients taking Celebrex have other illnesses and are taking multiple medications.
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