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News From the Food and Drug Administration
April 3, 2002

Pediatric Use of Mevacor

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JAMA. 2002;287(13):1640. doi:10.1001/jama.287.13.1640-JFD20004-2-1

The FDA has approved a new indication for lovastatin (Mevacor, Merck & Co Inc, Whitehouse Station, NJ), an approved cholesterol-lowering agent, as an adjunct to diet to reduce total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels in adolescent boys and in girls who are at least 1 year postmenarche who have heterozygous familial hypercholesterolemia (heFH).

The pediatric use is approved if (1) despite an adequate trial of diet therapy, LDL-C remains higher than 189 mg/dL; (2) LDL-C remains higher than 160 mg/dL and the patient has a family history of premature cardiovascular disease; or (3) two or more other risk factors for cardiovascular disease are present.