HIV drug proves deadly
- The U.S. Food and Drug Administration (FDA) and Boehringer Ingelheim Pharmaceuticals (BIP) say 13 patients taking BIP’s Aptivus HIV drug had bleeding in the brain, and eight died. FDA and BIP said there were 14 events of bleeding in 13 patients who were among 6,840 HIV-infected people participating in clinical studies of the drug. Aptivus was given conditional approval last year to treat HIV combined with Abbott Laboratories' Norvir. FDA sent a "Dear Health-care Professional" letter from BIP on its Web site. BIP, part of
's Boehringer Ingelheim GmbH, added the warning on the fatal and nonfatal bleeding episodes to the drug's black-box label. That label already warned of liver failure and some deaths in patients. BIP stated it "is confident about the benefit of Aptivus ... for patients within its labeled indication." FDA and BIP said investigation is ongoing but that many patients who had an intracranial hemorrhage had other medical woes, including head trauma and recent neurosurgery. Many patients were on other medications, including anticoagulants and antiplatelet agents, which may have played a role.