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Pain drug linked to deaths
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April 20, 1999: 6:22 p.m. ET
FDA reports association between Monsanto's Celebrex and 10 fatalities
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WASHINGTON (CNN) - A new widely prescribed painkiller drug, Celebrex, has been linked to 10 deaths and 11 cases of gastrointestinal hemorrhages in its first three months on the market, according to the Food and Drug Administration.
Five of the 10 people who died suffered from gastrointestinal bleeding or ulcers. Of the other deaths, two were attributed to heart attack, one to drug interaction and one to a kidney disorder. No cause was given for the other death, according to the FDA.
"It's too early to reach any conclusions about the drug's safety," an FDA spokesman told CNN.
The deaths and complications were part of the FDA's adverse-events report, filed quarterly. Reports of problems come from pharmaceutical companies, doctors and patients. An FDA spokesman pointed out that the report show an "association" between the drug and the deaths rather than an outright causal relationship.
"There is no indication these deaths and complications were caused by the use of Celebrex," said Scarlett Foster, a spokesperson for Searle & Co., a subsidiary of Monsanto Co. (MTC). "Before coming to any conclusions, we need to look at other medical conditions that could have contributed to these events."
According to the FDA's Center for Drug Evaluation and Research Information Branch, stomach disorders such as bleeding have occurred in people treated with Celebrex, although rarely.
Patient-information materials provided by Searle & Co. also state stomach ulcers can occur in patients using Celebrex without warning symptoms. Therefore, patients and their doctors should watch for signs and symptoms of stomach bleeding.
Last December, the FDA approved the drug Celebrex to treat rheumatoid arthritis and osteo-arthritis. Celebrex is the first in a new class of pain killers called Cox-2 inhibitors to get FDA approval. It became available to consumers in January.
In its first three months on the market, doctors have written 2.5 million prescriptions for Celebrex. This week an FDA advisory committee panel will decide if a second Cox-2 inhibitor, Vioxx, made by Merck & Co. (MRK), should be recommended for approval.
Celebrex treats pain as effectively as other NSAIDS, or non-steroidal anti-inflammatory drugs, such as ibuprofen, naproxen and aspirin, according to studies.
But unlike other NSAIDS, Celebrex is not supposed to cause serious stomach problems or deadly ulcers with long-term use. Each year 16,000 Americans die from gastrointestinal complications caused by NSAID use.
Other NSAIDS work by blocking enzymes known as Cox-1 and Cox-2. But Celebrex blocks only Cox-2, providing pain relief without stomach trouble. The hope was that Celebrex would be safer than other NSAIDS for long-term use.
Rheumatoid arthritis affects more than three million Americans, and osteo-arthritis affects about 16 million Americans. Both conditions cause pain and joint deterioration.
The FDA did not approve Celebrex for use in general pain conditions such as headache and menstrual pain.
Brad Stone, the FDA's press spokesman, said the agency is analyzing the patient and doctor reports. If it establishes a direct link between Celebrex and the deaths, it will likely act within a matter of weeks, perhaps with new warning labels or of a harmful interaction with another drug, if that proves to be the case.
Monsanto stock closed up 7/8 at 43 Tuesday. Merck & Co. leapt 2-1/8 to 75-1/4 for the day.
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