Thirteen patients taking the Aptivus HIV drug suffered bleeding on the brain, resulting in eight deaths. The Food and Drug Administration (FDA) and Boehringer Ingelheim Pharmaceuticals, the company that makes the drug, report that 6,840 people were participating in clinical studies of Aptivus since it was granted conditional approval to treat HIV last year.
Aptivus already had a black-box label, the FDA's strictest warning, noting a risk of liver failure. The drug manufacturer now added a warning regarding the fatal and nonfatal bleeding episodes.
The FDA and the manufacturer of Aptivus say the investigation is ongoing, but many patients who experienced bleeding on the brain had other medical conditions or took other medications that may have contributed to the intracranial hemorrhages.