FDA MedWatch

03/12/2008 -  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.

Read the complete 2008 MedWatch Safety Summaries including a link to the manufacturer's Dear Healthcare Professional Letter and Prescribing Information for Prezista concerning this issue at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista