HIV Protease Inhibitor Link To Diabetes Prompts Label Change

The US Food and Drug Administration has warned physicians that HIVprotease inhibitors "may contribute to increases in blood sugar and even diabetes in HIV patients," and recommends close monitoring of their glucose levels. In a letter to doctors, the agency noted that it had received 83 reported cases of new or exacerbated diabetes mellitus and hyperglycemia in patients taking the new drugs.

None of the data suggests that the drugs definitely cause the condition, stressed the agency, and there is no suggestion that patients forego protease inhibitor therapy. "Based on present information, [the FDA] continues to believe the benefits of these drugs to patients suffering from HIV infection outweigh the various risks of taking these drugs," it continued.

Of the 83 reported cases, 27 required hospitalization and there were six life-threatening episodes. Five cases resulted in ketoacidosis, a serious diabetes-related condition which can lead to coma or death if left untreated. Many patients who developed symptoms were able to control them through the use of insulin or other antidiabetic drugs, and in some cases symptoms receded on cessation of PI treatment. However, many cases occurred in patients with confounding medical conditions or who were taking other drugs that have been linked to similar side effects.