FDA Updates Black Box Warning on Boehringer Ingelheim's Protease Inhibitor Aptivus to Treat Drug-Resistant HIV
July 3, 2006
FDA and Boehringer Ingelheim on Friday updated the black box warning on Boehringer's protease inhibitor Aptivus, which is used in combination with Abbott Laboratories' Norvir for people living with HIV/AIDS who have become resistant to other drugs, the Wall Street Journal reports. FDA's black box warning is the strictest a drug can have, according to the Journal (Corbett Dooren, Wall Street Journal, 7/3). FDA in June 2005 granted conditional approval for the use of Aptivus in combination with Norvir (AP/Washington Post, 6/30). The approved dosage of Aptivus, which is known generically as tipranavir, is 500 milligrams in combination with 200 milligrams of Norvir, which is known generically as ritonavir, taken twice daily (Kaiser Daily HIV/AIDS Report, 10/27/05). According to the AP/Post, the updated black box warning comes after 14 documented cases of intracranial hemorrhaging occurred in 13 people taking Aptivus. Eight of the 13 people died, the AP/Post reports. The 13 people were among 6,840 HIV-positive people enrolled in clinical trials studying the drug combination. According to FDA, many of the people who developed hemorrhaging had other medical conditions or were taking other drugs that could have contributed to the bleeding. The updated warning recommends that physicians use caution in prescribing Aptivus to people who are at risk for increased bleeding (AP/Washington Post, 6/30). The Aptivus label also carries warnings of liver failure and death in people taking the drug, the Journal reports. FDA and Boehringer said that there will be further investigations to assess the role Aptivus played in the hemorrhages, according to the Journal (Wall Street Journal, 7/3).
This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.