FDA warns GSK's HIV drug may increase risk of heart attack

ROCKVILLE, Md. The Food and Drug Administration and GlaxoSmithKline have warned healthcare professionals of the risk of heart attack and buildup of cholesterol in patients taking a drug used to treat HIV.

The FDA released an alert Thursday announcing that it had modified the prescription information for the drug Lexiva (fosamprenavir calcium) to note that some patients taking the drug have experienced increases in cholesterol, a condition known as dyslipidemia, and recommend that patients undergo cholesterol and triglyceride testing before and during therapy with the drug.

In other news, the agency warned of possible birth defects among babies born to women who take the epilepsy drug valproate sodium and related drugs during pregnancy, including defects of the head and face and circulatory systems. Valproate sodium and related drugs are mostly available as generics, and Abbott Labs markets them under brand names such as Depacon (valproate sodium injection) and Depakote (divalproex sodium tablets).