FDA issues skin-disease warning for painkiller

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FDA issues skin-disease warning for painkiller

The Associated Press

WASHINGTON (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 s- 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.