The FDA announced a new warning December 3 about a potential link between Lexiva (fosamprenavir) and an increase in heart attacks. The warning and recommendations for monitoring for potential problems with Lexiva were issued through a letter to health care providers from Lexiva’s maker, GlaxoSmithKline.

The warning was spurred in part by a study presented at the 16th Conference on Retroviruses and Opportunistic Infections in January 2009 in Montreal. The study, coming out of the French Hospital Database on HIV, indicated that people taking Lexiva had about a 50 percent higher likelihood of a heart attack than people on other treatments per every year of additional treatment of Lexiva. The warning goes on to mention that protease inhibitors, in general, have been associated with higher rates of heart attacks and increases in cholesterol and triglycerides and that HIV itself has been linked to cardiovascular disease.

The new prescribing information recommends that doctors check cholesterol and triglyceride levels before prescribing Lexiva and regularly after initiating treatment. Moreover, people with cholesterol or triglyceride increases should be treated for those conditions.