By Lisa Seachrist

Washington Editor

WASHINGTON -- The FDA issued a health advisory to physicians alerting them to the potential for protease inhibitors to increase blood sugar levels and lead to diabetes. The agency isn't advising that HIV patients stop taking this newest class of AIDS-fighting drugs, but it is advising physicians to monitor their patients for this side effect.

The FDA noted that it had received reports of 83 cases of new or exacerbated diabetes mellitus and hyperglycemia in HIV-infected individuals taking protease inhibitors. Currently, there are four protease inhibitors on the market -- produced by Merck Research Laboratories, Hoffman-La Roche AG, Abbott Laboratories and Agouron Pharmaceuticals Inc. -- and all have been associated with this side effect.

"We have only seen two of these spontaneous reports of hyperglycemia out of 30,000 people taking Viracept," said Donna Nichols, senior director of corporate communications for Agouron, of La Jolla, Calif. Nichols noted that the FDA routinely monitors products post-market and this sort of very rare side effect is the purpose of that surveillance.

Untreated diabetes can be a life-threatening condition. However, the agency noted in its letter that this side effect is very rare in patients taking protease inhibitors the association didn't show up in the premarket studies of the drugs. It is estimated that between 140,000 and 150,000 people with HIV take one of the protease inhibitors.

Of the 83 patients who suffered the side effect, 27 required hospitalization, six with life-threatening cases. Five suffered ketoacidosis, a serious diabetes-related condition that causes fruity mouth odor, nausea, vomiting, diarrhea, weight loss, confusion and, if left untreated, coma or death. Many of the patients who developed diabetes while on protease inhibitors were able to control the disease with diet or insulin.

Because many of the patients who suffered this side effect were being treated for other medical conditions with drugs that are known to cause hyperglycemia and diabetes, the FDA can't be sure to what extent protease inhibitors are responsible for the side effect.

Nevertheless, the agency urged HIV patients on protease inhibitors to be aware of the symptoms of hyperglycemia and diabetes: increased thirst and hunger, unexplained weight loss, increased urination, fatigue and dry, itchy skin.

"We, like all of the other manufacturers, will be changing our product label accordingly," Nichols said.

Agouron's stock (NASDAQ:AGPH) closed Thursday at $82, down $4.125. *