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Adverse Drug Reaction
Group opposes over-the-counter status for Mevacor
February 20th, 2005
The March of Dimes opposes over-the-counter (OTC) status for Mevacor (lovastatin), a Pregnancy Category X drug (i.e., one that should not be taken during pregnancy). The March of Dimes comments came at a joint meeting in January 2005 of the U.S. Food and Drug Administration's Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees. The March of Dimes says some published data suggest that lovastatin may be teratogenic (capable of causing birth defects with fetal exposure). Changing lovastatin to OTC would reduce the ability of pregnant women to receive appropriate medical counseling on the potential risks of fetal exposure to...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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