Document Detail

Pregnancy outcome of women exposed to azathioprine during pregnancy.
MedLine Citation:
PMID:  17847119     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Azathioprine (AZP) interferes with nucleic acid synthesis and is teratogenic in animals. In view of the paucity of information on the use of AZP during pregnancy we investigated this subject in a prospective, controlled, multicenter study. Our objective was too determine whether exposure to AZP during pregnancy increases the risk for major malformations and to determine the effect on pregnancy outcome. METHODS: Pregnant women on AZP who contacted one of seven teratogen information services were compared to a cohort of pregnant women who contacted two of the seven teratogen information services and took nonteratogenic treatments during their pregnancy. RESULTS: Follow-up was completed on 189 women in the AZP group and compared to 230 women in the control group. The rate of major malformations did not differ between groups with six neonates in each; the AZP rate was 3.5% and the control group rate was 3.0% (p = .775; OR 1.17; CI: 0.37, 3.69). The mean birth weight and gestational age were lower in the AZP group (2,995 g vs. 3,252 g [p = .001, difference of mean: 257, 95% CI: 106.3, 408.1] and 37.8 weeks vs. 39.1 weeks [p = .001, difference of mean: 1.3, 95% CI: .5, 2.0], respectively). The AZP group had more cases of prematurity (21.4% vs. 5.2% [p < .001; OR 4.0; 95% CI: 2.0, 8.06]) and low birth weight (23% vs. 6.0% [p < .001; OR 3.81; 95% CI: 2.0, 7.2]). CONCLUSIONS: These results suggest that AZP (50-100 mg/day) does not triple the rate of birth defects; however, it is associated with lower birth weight, gestational age, and prematurity. Larger studies are needed to confirm these observations.
Lee Hilary Goldstein; Galit Dolinsky; Revital Greenberg; Christof Schaefer; Raanan Cohen-Kerem; Orna Diav-Citrin; Heli Malm; Minke E Reuvers-Lodewijks; Margreet M Rost van Tonningen-van Driel; Judith Arnon; Asher Ornoy; Maurizio Clementi; Elena Di Gianantonio; Gideon Koren; Rony Braunstein; Matitiahu Berkovitch
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Birth defects research. Part A, Clinical and molecular teratology     Volume:  79     ISSN:  1542-0752     ISO Abbreviation:  Birth Defects Res. Part A Clin. Mol. Teratol.     Publication Date:  2007 Oct 
Date Detail:
Created Date:  2007-10-15     Completed Date:  2007-12-12     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101155107     Medline TA:  Birth Defects Res A Clin Mol Teratol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  696-701     Citation Subset:  IM    
Clinical Pharmacology Unit, Teratogen Information Service, Assaf Harofeh Medical Center, Sackler School of Medicine, Tel Aviv University, Israel.
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MeSH Terms
Abnormalities, Drug-Induced* / epidemiology
Azathioprine / administration & dosage,  adverse effects*
Case-Control Studies
Gestational Age
Immunosuppressive Agents / administration & dosage,  adverse effects*
Infant, Low Birth Weight*
Infant, Newborn
Live Birth* / epidemiology
Premature Birth / chemically induced*,  epidemiology
Prospective Studies
Reg. No./Substance:
0/Immunosuppressive Agents; 446-86-6/Azathioprine

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

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