FDA Approves AIDS Drug; Can Threaten Lives of Some Patients

The Food and Drug Administration has approved a new AIDS drug but warned that it sometimes causes a life-threatening reaction.

Glaxo Wellcome Inc.’s Ziagen, known chemically as abacavir, won FDA approval late Thursday as part of multidrug therapy for patients with the AIDS virus.

Glaxo says Ziagen requires swallowing one tablet twice a day without the dietary restrictions of some competitors.

But about 5% of HIV patients suffer a hypersensitivity reaction to the drug that can be life-threatening, said FDA antiviral chief Dr. Heidi Jolson.

Symptoms include fever, fatigue, nausea, vomiting and rash, and usually occur within the first six weeks of therapy. Those symptoms can be confused with side effects from other HIV drugs.

“Physicians and patients would have to . . . err on the side of caution” by immediately stopping the drug, Jolson stressed.

The FDA mandated that every patient receive a detailed notice explaining the reaction and what to do if they experience symptoms, plus a wallet-sized card to carry that describes symptoms in layman’s terms.