HIV Digest	HIV Digest Archive

The US Food and Drug Administration (FDA) and Boehringer Ingelheim have reported that 13 patients taking the company's HIV drug Aptivus had bleeding in the brain, and eight of them died.

There were 14 events of intracranial hemorrhage in 13 patients who were among 6,840 HIV-infected people taking part in clinical studies of Aptivus, said FDA and Boehringer Ingelheim Pharmaceuticals. The drug was granted conditional approval last year to treat HIV in combination with Abbott Laboratories' Norvir.

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he FDA posted a statement and a "Dear Health-care Professional" letter from the drug maker on its website. Boehringer added a warning on the fatal and nonfatal bleeding episodes on Aptivus's black-box label, the strictest FDA warning a drug can carry. That label already warns of liver failure and some deaths in patients.

In a statement, Boehringer said that it "is confident about the benefit of Aptivus. for patients within its labeled indication."

Further investigation is ongoing, the FDA and the company said, noting that many patients who experienced an intracranial hemorrhage had additional medical conditions such as head trauma and recent neurosurgery. Many patients were also taking other medications, including anticoagulants and antiplatelet agents, which could have played a role in the intracranial bleedings.

from the Wall Street Journal