March of Dimes Opposes Over-the-Counter Status for Mevacor

WASHINGTON, JAN. 13, 2005 -- The March of Dimes opposes over-the-counter (OTC) status for Mevacor (lovastatin), a Pregnancy Category X drug -- one that should not be taken during pregnancy.

The March of Dimes comments came at a joint meeting today of the Food & 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 this drug.  Increasing maternal ages and widespread public recognition of statins may increase the likelihood of statin use during pregnancy.  Moreover, since 50 percent of all pregnancies in the United States are unplanned, OTC availability of potential teratogens could affect many pregnancies by early, unintended pregnancy exposures.

No drug should be permitted to go from prescription to OTC until adequate data are available regarding its safety or risk of use in human pregnancy, so that FDA may make informed decisions about its safety and proper package labeling, the March of Dimes says.

The March of Dimes points out that even though Mevacor's proposed OTC label targets women at least 55 years of age, in the manufacturer's OTC actual use study, 37.4 percent of female participants who chose to take the drug were below that age, and 11 percent were below age 45, thus within childbearing age.

The March of Dimes respectfully advises the Food & Drug Administration's Nonprescription Drugs and Endocrinologic and Metabolic Drugs Advisory Committees to carefully consider the potential impact of OTC lovastatin on the health of our nation's infants and to recommend that lovastatin not be made available OTC until there are more data on its safety in pregnancy.