Document Detail


Prenatal exposure to HMG-CoA reductase inhibitors: effects on fetal and neonatal outcomes.
MedLine Citation:
PMID:  18640262     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Use of HMG-CoA reductase inhibitors (statins) is becoming increasingly common. However, a recent study based on a series of cases reported to FDA suggests possible teratogenic effects of statins on embryogenesis, such as limb defects and severe central nervous system anomalies. METHODS: In a prospective, observational cohort study with a comparison group to examine a fetal toxicity risk of statins, we followed 64 pregnant women taking statins, and 64 comparison group women without exposure to known teratogens. The statin group women were exposed to atorvastatin (n=46), simvastatin (n=9), pravastatin (n=6), or rosuvastatin (n=3) during the first trimester. RESULTS: There was no difference in the rate of major malformations between the statin group (1/46 live birth: 2.2%) and the comparison group (1/52 live birth: 1.9%, p=0.93). Similarly, there were no statistical differences between the statin and comparison groups in live births (71.9% vs 81.2%), spontaneous abortions (14: 21.9% vs 11: 17.2%), therapeutic abortions (3: 4.7% vs 0: 0%) and stillbirths (1: 1.5% vs 1: 1.6%). Gestational age at birth (38.4+/-2.8 weeks vs 39.3+/-1.3 weeks: M+/-S.D., p=0.04) and birth weight (3.14+/-0.68kg vs 3.45+/-0.42kg, p=0.01) were lower in the statin group. CONCLUSIONS: The absolute risk of teratogenicity of statins, if any, appears relatively small. A large-scale study is needed to further characterize the teratogenic potential.
Authors:
Nobuko Taguchi; Evelyn T Rubin; Akiko Hosokawa; Jacquelyn Choi; Angela Yating Ying; Myla E Moretti; Gideon Koren; Shinya Ito
Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2008-07-01
Journal Detail:
Title:  Reproductive toxicology (Elmsford, N.Y.)     Volume:  26     ISSN:  0890-6238     ISO Abbreviation:  Reprod. Toxicol.     Publication Date:  2008 Oct 
Date Detail:
Created Date:  2008-10-20     Completed Date:  2008-12-08     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8803591     Medline TA:  Reprod Toxicol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  175-7     Citation Subset:  IM    
Affiliation:
The Motherisk Program, Division of Clinical Pharmacology and Toxicology, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Canada.
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MeSH Terms
Descriptor/Qualifier:
Abnormalities, Drug-Induced / epidemiology,  etiology
Birth Weight / drug effects
Case-Control Studies
Cohort Studies
Female
Fetal Development / drug effects*
Gestational Age
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors / administration & dosage,  adverse effects*,  therapeutic use
Infant, Newborn
Pregnancy
Pregnancy Outcome* / epidemiology
Prenatal Exposure Delayed Effects / chemically induced*,  epidemiology
Prospective Studies
Chemical
Reg. No./Substance:
0/Hydroxymethylglutaryl-CoA Reductase Inhibitors

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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