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FDA Upgrades Black Box Warning on Aptivus

Intracranial hemorrhages and eight deaths reported in HIV-1 patients taking Aptivus

FRIDAY, July 7 (HealthDay News) -- The U.S. Food and Drug Administration has upgraded the black box warning label on Aptivus (tipranavir) given with 500 milligram and 200 milligram doses of ritonavir, after several cases of intracranial hemorrhage and eight deaths occurred in HIV patients taking the drug in combination antiretroviral therapy.

The drug's manufacturer, Boehringer Ingelheim, reported that 14 out of 6,840 HIV-1 patients experienced intracranial hemorrhages and eight patients died during clinical studies involving a combination of Aptivus capsules and antiretroviral drugs.

Many of those who had intracranial hemorrhages had other medical problems, ranging from hypertension to head trauma, according to the FDA statement. Many were taking other drugs, such as antiplatelet agents or anticoagulants, that could have provoked or contributed to the hemorrhages.

The FDA also said that patients showed no abnormal coagulation patterns while taking Aptivus or before having hemorrhages.

"Routine measurement of coagulation parameters is not currently indicated in the management of patients on Aptivus," according to the FDA. "An increased risk of intracranial hemorrhage was previously observed in patients with advanced HIV-1 disease/AIDS."

More Information - FDA
More Information - Letter to Health Care Providers
More Information - Prescription Revision

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