FDA Warns of Heart Attacks, High Cholesterol From HIV Drug Lexiva
The Food and Drug Administration is warning doctors about a possible link between the GlaxoSmithKline HIV drug Lexiva and greater risks of heart attacks and increased cholesterol.
The drug company has updated the existing warnings and precautions section on the drug’s prescribing information to reflect the risk, after a new study found patients taking Lexiva (also called fosamprenavir calcium) were at increased risks, the FDA announced today.
GlaxoSmithKline and the FDA also notified healthcare professionals of the potential association between Lexiva and heart attack (myocardial infarction) and dyslipidemia in HIV infected adults. Also, about 19 percent of Lexiva users in clinical studies developed skin rashes, the FDA said.
The agency’s “Dear Healthcare Professional” letter also cautions physicians to carefully monitor Lexiva patients for physical signs of fat redistribution as well as triglyceride and cholesterol levels before and during use of the drug.
Lexiva patients with other cardiovascular risk factors, such as smoking, hypertension, and diabetes, also should be closely monitored for health complications while on the drug, the FDA said.
Glaxo noted that the class of drugs Lexiva falls into is associated with increases in cholesterol and other blood lipids, which in turn raises the risk of heart attacks, according to a report in The Wall Street Journal.
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