Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure

To the Editor: The cholesterol-lowering statin drugs are contraindicated in pregnancy1; therefore, few data exist regarding their safety in human gestation. We reviewed 178 cases of first-trimester statin exposure reported to the Food and Drug Administration (FDA) from 1987 through 2001 for patterns suggesting possible drug-related effects on embryogenesis. After the exclusion of cases involving first-trimester elective or spontaneous abortions (46 and 42 cases, respectively), pregnancy loss due to maternal illness (15), fetal genetic disorders (3), transient neonatal disorders (5), or loss to follow-up (15), 52 cases were considered evaluable (Table 1). Among these cases, there were 20 reports . . .