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FDA rejects over the counter sale of cholesterol drug Mevacor
Federal advisers voted 20 to 3 against making Mevacor available without a prescription due to safety concerns and the need for medical guidance in treating a chronic asymptomatic condition. They warned pregnant women could unintentionally harm a fetus and noted most OTC users would not meet label criteria.
MENTIONED IN THIS ARTICLE
Bethesda, Md
Food and Drug Administration
Frank F Davidoff
Annals of Internal Medicine
Johnson & Johnson-Merck Consumer Pharmaceuticals Co