APTIVUS SAFETY ALERT

Health Canada issued in July, 2006, a safety alert on Aptivus antiviral agent. APTIVUS co-administered with low dose ritonavir is indicated for combination antiretroviral treatment of HIV-1 infected adult patients. There have been 14 reports of intracranial hemorrhage (ICH), including 8 fatalities, in 6840 HIV-1 infected patients receiving APTIVUS in clinical trials. Many of the patients experiencing ICH in the APTIVUS clinical trials had other medical conditions (CNS lesions, head trauma, neurosurgery, coagulopathy, hypertension or alcohol abuse) or were receiving concomitant medications, including anticoagulants and antiplatelet agents, that may have caused or contributed to these events. Tipranavir has been observed to inhibit human platelet aggregation in vitro. APTIVUS/ritonavir should therefore be used with caution in patients who may be at risk for increased bleeding from trauma, surgery or other medical conditions, or who are receiving medications known to increase the risk of bleeding, including antiplatelet agents or anticoagulants.