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FDA Warns of Heart Attacks, High Cholesterol with Lexiva

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The U.S. Food & Drug Administration has warned that GlaxoSmithKline’s HIV drug, Lexiva, may be associated with  increase in heart attacks in adult HIV patients.  According to a posting on the FDA Web site, Lexiva has also been seen to raise cholesterol levels.

New information about these possible risks is being added to the “Warning and Precautions” section of the Lexiva label.  Physicians have been advised 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.

According to a “Dear Healthcare Professional Letter” from Glaxo that is posted on the FDA Web site, a French study (FHDH ANRS CO4) presented to the Conference on Retroviruses and Opportunistic Infections earlier this year showed that each year of Lexiva therapy  increased the risk of heart attack by 54 percent.  The letter 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.

Glaxo said it is  in communication with the FDA and this issue will be closely monitored

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