Maternal exposure to statins and risk for birth defects: a case-series approach.

摘要

Statins are the most commonly prescribed class of cholesterol-lowering medications because of their efficacy in reducing low-density lipoprotein (LDL) levels and their tolerability and safety profiles [Maron et al, 2000]. However, the effects of maternal statin exposure on the fetus have not been well studied. Edison and Muenke [2004a,b] reviewed data on cases of first trimester maternal statin exposure spontaneously reported to the FDA from 1987 to 2001 to determine if a pattern of defects suggesting teratogenicity was present. Among these cases were 22 infants with structural birth defects, including 4 with defects in the central nervous system (1 with holoprosencephaly, 1 with hydrocephalus secondary to aqueductal stenosis, and 2 with neural tube defects) and 5 with unilateral limb deficiencies (2 of which had defects consistent with VACTERL [vertebral, anal, cardiac, tracheal, esophageal, renal, and limb] association).