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A correction has been published: N Engl J Med 2005;352(26):2759.

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Volume 350:1579-1582 April 8, 2004 Number 15
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Central Nervous System and Limb Anomalies in Case Reports of First-Trimester Statin Exposure

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 by Edison, R. J.
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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).

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Table 1. Congenital Anomalies Associated with First-Trimester . . . [Full Text of this Article]

 

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