Access To Justice

Healthcare professionals received a warning last week from GlaxoSmithKline (GSK) about a potential link between heart attacks and its HIV medication Lexiva.

Lexiva (fosamprenavir calcium) is prescribed with other antiretroviral drugs to treat HIV.

GSK has revised the warnings and precautions section of the drug’s prescribing Information to note that increases in cholesterol have occurred with treatment, the importance of lipids management, and a recommendation that triglyceride and cholesterol testing be performed prior to initiating therapy with Lexiva and periodically during therapy, according to the U .S. Food and Drug Administration (FDA). 

The FDA posted on its website a letter from GSK written to doctors describing the Lexiva label changes. The letter says the company is “in communication with FDA and this issue will be closely monitored.”

GSK’s updated label also alerts doctors to data presented at a medical conference last February that suggested that HIV-infected patients taking Lexiva had an increased risk of having a heart attack.