The Food and Drug Adminstration (FDA) and GlaxoSmithKline (GSK) added warnings of increased risk of heart attack and dyslipidemia (elevated cholesterol and lipid levels) to the prescribing information for Lexiva (fosamprenavir), an anti-HIV drug.

GSK, the drug’s manufacturer, has updated existing prescribing information to include the potential for Lexiva to increase cholesterol levels, which is known to raise the risk of heart attacks.

GSK recommends testing triglycerides and cholesterol levels in patients, both initially and at set intervals throughout the course of therapy.

Evidence for this increased risk comes from a French case-controlled study, which found a positive correlation between Lexiva use and heart attack incidence.

Lexiva is a type of antiretroviral drug known as a protease inhibitor that is indicated for use in combination therapy with other antiretroviral drugs. Protease inhibitors work by disabling protease, a protein that HIV needs in order to replicate. In general, GSK noted that protease inhibitors tend to be associated with higher levels of cholesterol and other lipids in the blood.

Lexiva is not the first HIV drug to be associated with cardiovascular disease. Ziagen (abacavir) has also been associated with increased risk of heart problems (see related AIDS Beacon news).

HIV infection itself is also associated with lipid disorders and ischemic heart disease, a disease in which the heart’s blood supply is reduced. In a recent study conducted in Italy, scientists show that without antiretroviral treatment, HIV-infected individuals have an increased risk of cardiovascular disease (see related AIDS Beacon news).

For more information, please see the press release on the FDA Web site, which also provides a link to GSK’s letter (pdf) to all health professionals.