HIV Drug Lexiva May Increase Cholesterol and Heart Attack Risk: FDA

The FDA has posted a warning for healthcare professionals that the HIV drug Lexiva may cause an increase in the risk of heart attacks and high cholesterol.

GlaxoSmithKline, which manufactures Lexiva (fosamprenavir calcium), sent a letter to doctors last month alerting them to new data that suggests an association between the antiretrovirus drug, and myocardial infarction and hypercholesterolemia. The prescribing information and drug warnings on the label will be updated to reflect the potential increased risk.

Lexiva was approved by the FDA in October 2003 for use as part of a combination of antiretroviral drugs for the treatment of the human immunodeficiency virus (HIV). The drug is manufactured by GlaxoSmithKline, and marketed by ViiV Healthcare, a joint subsidiary of Glaxo and Pfizer, Inc.

The Lexiva heart attack side effects were reported as a result of a February 2009 European case-control study which found the association to myocardial infarction through analysis of the French Hospital Database on HIV.

Similar drugs, protease inhibitors, have already been linked with increased risk of myocardial infarction, and officials at GlaxoSmithKline say that the association may be related to the drug’s propensity for raising blood lipids. The HIV virus itself is also associated with heart disease and lipid disorders, according to the “Dear Healthcare Professional” letter.

Changes being made to the labeling and prescription guide include the addition of myocardial infarction and hypercholesterolemia to the Adverse Reactions section of the prescribing information. The changes also include a recommendation that triglyceride and cholesterol testing be performed before beginning Lexiva therapy, and at periodic intervals once use of Lexiva has began.