This warning has been added in response to a report by Boehringer Ingelheim, the company that manufactures Aptivus, which stated that 14 patients out of 6,800 in a clinical trial had suffered from intracranial hemorrhage, or bleeding inside the skull. Of these patients, eight died as a result of the bleeding.
The drug company noted that many of the patients who experienced brain bleeding had other conditions, such as head trauma, recent brain surgery, problems with blood clotting, lesions in the central nervous system, high blood pressure or alcohol abuse, which may have complicated their situation. Intracranial hemorrhage is also known to occur in patients with HIV infection on other anti-viral drugs and occasionally even in untreated patients.
These conditions may increase the risk of using Aptivus, but the FDA states that "further investigations are ongoing to assess the role of Aptivus in intracranial hemorrhage."
As such, the FDA's letter to doctors about the warning states, "Aptivus should be used with caution in patients who may be at risk for increased bleed from trauma, surgery or other medical conditions."
The drug already has a separate "black-box" warning over concerns that use of the drug can lead to severe liver problems, specifically in patients with liver disease, which is common in HIV patients.
Aprituvs is in a class of drugs called protease inhibitors, which work to suppress HIV by blocking an enzyme the virus needs to make copies of itself.