BI's Aptivus linked to intracranial bleeding

German drugmaker Boehringer Ingelheim says it has observed 14 cases of intracranial hemorrhage, eight of which were fatal, during clinical assessment of its anti-HIV treatment Aptivus (tipranavir) capsules, used in combination with Abbott Laboratories' Norvir (ritonavir). The firm added it had issued a letter to health care providers in the US, explaining that no spontaneous reports of intracranial bleeding had been linked to marketed Aptivus, and that no such events had been seen in pediatric and treatment-naive trials of the drug.

Boehringer added that its thorough, case-by-case analysis of each of the recorded events, has revealed that many of the patients experiencing a hemorrhage had other medical conditions such as nervous system lesions, head trauma, coagulopathy and recent neuropathy, or were receiving additional medication, factors which may have contributed to the reaction.

Product warning label update