Early pregnancy azathioprine use and pregnancy outcomes.

Hdl Handle:
http://hdl.handle.net/10147/208020
Title:
Early pregnancy azathioprine use and pregnancy outcomes.
Authors:
Cleary, Brian J; Kallen, Bengt
Affiliation:
Pharmacy Department, Coombe Women and Infants University Hospital, Dublin 8,, Ireland. bcleary@coombe.ie
Citation:
Birth Defects Res A Clin Mol Teratol. 2009 Jul;85(7):647-54.
Journal:
Birth defects research. Part A, Clinical and molecular teratology
Issue Date:
1-Feb-2012
URI:
http://hdl.handle.net/10147/208020
DOI:
10.1002/bdra.20583
PubMed ID:
19343728
Abstract:
BACKGROUND: Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.
Language:
eng
MeSH:
Abnormalities, Drug-Induced/epidemiology/metabolism; Adult; Anti-Inflammatory Agents/*adverse effects; Azathioprine/*adverse effects; Congenital Abnormalities/epidemiology; Female; Humans; Infant, Newborn; Inflammatory Bowel Diseases/drug therapy; Middle Aged; Pregnancy; Pregnancy Outcome/*epidemiology; Registries; Young Adult
ISSN:
1542-0760 (Electronic); 1542-0752 (Linking)

Full metadata record

DC FieldValue Language
dc.contributor.authorCleary, Brian Jen_GB
dc.contributor.authorKallen, Bengten_GB
dc.date.accessioned2012-02-01T10:57:54Z-
dc.date.available2012-02-01T10:57:54Z-
dc.date.issued2012-02-01T10:57:54Z-
dc.identifier.citationBirth Defects Res A Clin Mol Teratol. 2009 Jul;85(7):647-54.en_GB
dc.identifier.issn1542-0760 (Electronic)en_GB
dc.identifier.issn1542-0752 (Linking)en_GB
dc.identifier.pmid19343728en_GB
dc.identifier.doi10.1002/bdra.20583en_GB
dc.identifier.urihttp://hdl.handle.net/10147/208020-
dc.description.abstractBACKGROUND: Azathioprine (AZA) is used during pregnancy by women with inflammatory bowel disease (IBD), other autoimmune disorders, malignancy, and organ transplantation. Previous studies have demonstrated potential risks. METHODS: The Swedish Medical Birth Register was used to identify 476 women who reported the use of AZA in early pregnancy. The effect of AZA exposure on pregnancy outcomes was studied after adjustment for maternal characteristics that could act as confounders. RESULTS: The most common indication for AZA use was IBD. The rate of congenital malformations was 6.2% in the AZA group and 4.7% among all infants born (adjusted OR: 1.41, 95% CI: 0.98-2.04). An association between early pregnancy AZA exposure and ventricular/atrial septal defects was found (adjusted OR: 3.18, 95% CI: 1.45-6.04). Exposed infants were also more likely to be preterm, to weigh <2500 gm, and to be small for gestational age compared to all infants born. This effect remained for preterm birth and low birth weight when infants of women with IBD but without AZA exposure were used as a comparison group. A trend toward an increased risk of congenital malformations was found among infants of women with IBD using AZA compared to women with IBD not using AZA (adjusted OR: 1.42, 95% CI: 0.93-2.18). CONCLUSIONS: Infants exposed to AZA in early pregnancy may be at a moderately increased risk of congenital malformations, specifically ventricular/atrial septal defects. There is also an increased risk of growth restriction and preterm delivery. These associations may be confounded by the severity of maternal illness.en_GB
dc.language.isoengen_GB
dc.subject.meshAbnormalities, Drug-Induced/epidemiology/metabolismen_GB
dc.subject.meshAdulten_GB
dc.subject.meshAnti-Inflammatory Agents/*adverse effectsen_GB
dc.subject.meshAzathioprine/*adverse effectsen_GB
dc.subject.meshCongenital Abnormalities/epidemiologyen_GB
dc.subject.meshFemaleen_GB
dc.subject.meshHumansen_GB
dc.subject.meshInfant, Newbornen_GB
dc.subject.meshInflammatory Bowel Diseases/drug therapyen_GB
dc.subject.meshMiddle Ageden_GB
dc.subject.meshPregnancyen_GB
dc.subject.meshPregnancy Outcome/*epidemiologyen_GB
dc.subject.meshRegistriesen_GB
dc.subject.meshYoung Adulten_GB
dc.titleEarly pregnancy azathioprine use and pregnancy outcomes.en_GB
dc.contributor.departmentPharmacy Department, Coombe Women and Infants University Hospital, Dublin 8,, Ireland. bcleary@coombe.ieen_GB
dc.identifier.journalBirth defects research. Part A, Clinical and molecular teratologyen_GB
dc.description.provinceLeinster-

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