Anti-HIV drug
tried to eight deaths

The protease inhibitor Aptivus, developed by Boehringer Ingelheim, has been linked to bleeding of the brain in 13 HIV patients, eight of whom died from the condition, The Wall Street Journal reports. Because of the severity of the adverse side effects, the Food and Drug Administration has ordered the drugmaker to include a new black-box warning on the drug's label indicating the possibility of brain bleeding. The label already warns of possible liver problems that can be severe in some HIV patients.

Boehringer-Ingelheim reported a total of 14 cases of intracranial hemorrhage in 13 of the 6,840 HIV patients participating in a long-term clinical trial of Aptivus, which was approved for marketing by the FDA last year. The FDA and Boehringer Ingelheim are investigating whether the concurrent use of anticoagulant drugs and antiplatelet agents could have lead to the brain hemorrhages. They're also studying whether patients who had recent head trauma or neurosurgery were at a higher risk for the complication. (The Advocate)