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FDA Issues Liver Warnings for Antiretroviral Drug

Prezista is suspected of causing hepatotoxicity

MONDAY, March 24 (HealthDay News) -- On Friday, the U.S. Food and Drug Administration warned health care providers and patients about a potential risk of hepatotoxicity associated with the use of Prezista (darunavir ethanolate), an antiretroviral drug used to treat HIV infection.

The FDA's announcement follows a review of data from clinical trials of Prezista and postmarketing adverse event reports of hepatotoxicity linked to the drug's use. Prezista, a protease inhibitor, is typically co-administered with ritonavir, another antiretroviral drug associated with hepatotoxicity. While clear causation of liver injury by Prezista has not been firmly established, it is suspected, according to the FDA.

The FDA recommends that health care providers perform hepatic laboratory testing before and after initiating therapy with Prezista. Patients with co-existing liver disease, such as chronic active hepatitis B or C, should be monitored more frequently. Patients who experience signs and symptoms of liver injury, such as unexplained fatigue, anorexia, nausea, jaundice, abdominal pain or dark urine should promptly seek medical attention. Prezista should be discontinued if patients develop evidence of new or worsening liver injury.

The FDA has worked with the manufacturer of Prezista, Tibotec Therapeutics, to include this new safety information in the drug's prescribing information. Any unexpected or serious adverse events associated with the use of Prezista should be reported to the FDA.

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