WASHINGTON (AP) – The strict “black-box” warning on the label of an HIV drug approved just last year is being updated to warn of sometimes fatal bleeding within the brain or skull tissue, health officials said Friday.

The Food and Drug Administration said it has received 14 reports of intracranial hemorrhaging in patients treated in clinical trials with the drug, Aptivus, in combination with the older HIV drug ritonavir.

Eight of those patients died, among the 6,840 enrolled in trials of the drug combination.

Many of the hemorrhage patients had other medical conditions or were taking other drugs that could have contributed to the bleeding, the FDA said. Further investigations seek to assess the drug’s role.

The new warnings recommend doctors use caution in prescribing Aptivus, also known as tipranavir, to patients at risk for increased bleeding.

Examples include people who have suffered trauma or undergone surgery, or who are taking anticoagulants.

The FDA approved Aptivus in June 2005; it approved ritonavir, sold as Norvir, in 1996.

Aptivus’ black-box warning, the strictest a prescription drug can bear, previously warned only of the risk of severe liver disease when used with ritonavir. The two drugs are always taken together, along other HIV drugs.

Aptivus is made by Boehringer Ingelheim Pharmaceuticals Inc.



On the Net:

Food and Drug Administration letter to doctors:

http://www.fda.gov/medwatch/safety/2006/Aptivus-tipranavir-DHCP.pdf

Updated Aptivus label: http://www.fda.gov/medwatch/safety/2006/Aptivus-PI.pdf


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