The U.S. Food and Drug Administration (FDA) has released a warning letter about Boehringer
Ingelheim Pharmaceuticals’ HIV drug Aptivus®, after several patients experienced bleeding in
the brain. Aptivus® first received FDA approval in June 2005.
In a clinical trial that included 6,840 HIV-infected participants, 13 patients experienced
intracranial bleeding and eight died. In response Boehringer Ingelheim placed a “black box”
warning on all labels for Aptivus®. The paragraph is positioned inside the box to signify the
FDA’s strictest warning. In addition, Boehringer Ingelheim recently sent a letter informing
healthcare professionals of the new safety warning for Aptivus®, mentioning the fatal
intracranial bleeding that has occurred in some patients.
The FDA and Boehringer Ingelheim have said that while investigations are ongoing, other risk
factors may have played a part in the bleeding-related complications. Patients who have
experienced recent head trauma or neurosurgery, or those taking certain medications such as
anticoagulants or antiplatelet agents, may have been at increased risk for intracranial bleeding.
Read the “Dear Healthcare Professional” warning letter>>
Read the black box warning label for Aptivus®>>
Source: The Washington Post, June 30, 2006 and The Wall Street Journal, July 3, 2006