Prezista (darunavir) and hepatoxicity
admin March 14th, 2008
Prezista (darunavir) has had warnings added in relation to hepatotoxicity by the FDA:
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
Darunavir is currently a black triangle drug in the United Kingdom, meaning that any adverse effects, no matter how trivial, should be reported to the Yellow Card scheme.
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