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

8 April 2004

journal article
letter
Published by Massachusetts Medical Society in New England Journal of Medicine

Vol. 350 (15) , 1579-1582
https://doi.org/10.1056/nejm200404083501524

Abstract

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 ).

Keywords

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