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NEW WARNING
Tibotec Therapeutics has issued a “Dear Healthcare Professional” letter about updates to prescribing information for their antiviral drug darunavir (Prezista). Postmarketing studies have shown incidence of drug-induced hepatitis when darunavir is used as part of combination therapy in the treatment of HIV infections. The new prescribing information includes warnings about hepatotoxicity, including potentially fatal hepatitis. Patients with preexisting liver disease are at increased risk. They suggest pretreatment and periodic monitoring of liver function tests and interruption or discontinuation of treatment in patients with elevation of liver enzymes and signs and symptoms of liver dysfunction (fatigue, anorexia, jaundice, nausea, dark urine, liver tenderness and enlargement.) Patients should be advised to report these symptoms immediately.
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darunavir