Abstract
On June 30, 2006, the FDA and Boehringer Ingelheim announced that they will expand the black box warning on tipranavir to include the risk of intracranial hemorrhage (ICH). Evidence for the warning came from clinical trials involving 6840 HIV-infected patients who received ritonavir-boosted tipranavir (500 mg + 200 mg boost, twice daily) as part of combination antiretroviral therapy. Of these patients, 13 (0.2%) had ICH events; 8 died. The median time from initiation of boosted-tipranavir treatment to onset of ICH was 525 days. In …
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