Monsanto Celebrex Linked to 10 Deaths

(Excerpts From The Associated Press)
AP-NY-04-20-99 0514 EDT

NEW YORK (AP) -- 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.'s G.D. Searle & Co. subsidiary, went on the market in January 1999 to treat osteoarthritis and rheumatoid arthritis.

Drug Category: Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), Specifically Cyclo-Oxygenase-2 (COX-2) Inhibitors, for Rheumatoid Arthritis and Osteoarthritis.

Description: COX-2 inhibitors, like traditional NSAIDs, block COX-2, an enzyme in the body known to stimulate an inflammatory response. Unlike traditional NSAIDs, however, they do not block the action of COX-1, an enzyme known to protect the stomach lining. Therefore, drugs in this category reduce joint pain and inflammation with reduced risk of gastrointestinal ulceration and bleeding.

Medication (drugname): Celebrex® (celecoxib).

How taken: orally once or twice daily, dosage determined by the physician

Most common side effects: abdominal pain, nausea, indigestion, diarrhea.

Medication (drugname): Vioxx® (rofecoxib) for rheumatoidarthritis and osteoarthritis, as well as acute pain associated with primary dysmenorrhea (painful menstruation) and postsurgical pain.

How taken: orally, once daily.

Most common side effects: abdominal pain, diarrhea, indigestion, insomnia, edema.

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