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FDA Issuses Warning About Painkiller

Nov 15, 2002 | AP

People who develop a rash upon taking a new painkiller called Bextra should immediately stop the drug because it has been linked to some rare but life-threatening skin diseases, federal health officials warned Friday.

The Food and Drug Administration has about 20 reports of serious reactions including the skin diseases Stevens-Johnson syndrome, toxic epidermal necrolysis and exfoliative dermatitis, as well as allergic reactions among Bextra users since sales began in March.

The FDA estimates about 800,000 to 1 million people had recently begun taking Bextra when the reactions were reported. The immune system-linked skin disorders are thought to be more likely during the first few weeks of a drug's use than after the body becomes accustomed to the medicine.

Still, because those skin conditions are so rare, the FDA was surprised to see even that small cluster reported during Bextra's first year of sales. The conditions can be lifethreatening, and a few of the patients required hospitalization.

Stopping Bextra at the first sign of a rash lowers the chance of suffering a severe reaction, said Dr. Lawrence Goldkind, FDA's deputy director for painkillers.

In addition, the FDA warned that Bextra should not be used by anyone allergic to sulfa-containing drugs.

Bextra maker Pharmacia Corp. wrote thousands of doctors this week alerting them to the warning.

Bextra, known chemically as valdecoxib, treats arthritis and menstrual pain by reducing inflammation. It is a type of painkiller known as a cox-2 inhibitor.

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