Specific SSRIs and birth defects: bayesian analysis to interpret new data in the context of previous reports [SSRIs药物的具体类型与出生缺陷：用贝叶斯分析方法在过往报告的情境中诠释新数据]

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BMJ 2015; 351 doi: http://dx.doi.org/10.1136/bmj.h3190 (Published 08 July 2015)

Cite this as: BMJ 2015;351:h3190 

Authors
Jennita Reefhuis, research health scientist, Owen Devine, senior statistician, Jan M Friedman, professor, Carol Louik, epidemiologist, Margaret A Honein, senior research health scientist on behalf of the National Birth Defects Prevention Study

Abstract
Objective: To follow up on previously reported associations between periconceptional use of selective serotonin reuptake inhibitors (SSRIs) and specific birth defects using an expanded dataset from the National Birth Defects Prevention Study.

Design: Bayesian analysis combining results from independent published analyses with data from a multicenter population based case-control study of birth defects.

Setting: 10 centers in the United States.

Participants: 17 952 mothers of infants with birth defects and 9857 mothers of infants without birth defects, identified through birth certificates or birth hospitals, with estimated dates of delivery between 1997 and 2009.

Exposures: Citalopram, escitalopram, fluoxetine, paroxetine, or sertraline use in the month before through the third month of pregnancy. Posterior odds ratio estimates were adjusted to account for maternal race/ethnicity, education, smoking, and prepregnancy obesity.

Main outcome measure: 14 birth defects categories that had associations with SSRIs reported in the literature.

Results: Sertraline was the most commonly reported SSRI, but none of the five previously reported birth defects associations with sertraline was confirmed. For nine previously reported associations between maternal SSRI use and birth defect in infants, findings were consistent with no association. High posterior odds ratios excluding the null value were observed for five birth defects with paroxetine (anencephaly 3.2, 95% credible interval 1.6 to 6.2; atrial septal defects 1.8, 1.1 to 3.0; right ventricular outflow tract obstruction defects 2.4, 1.4 to 3.9; gastroschisis 2.5, 1.2 to 4.8; and omphalocele 3.5, 1.3 to 8.0) and for two defects with fluoxetine (right ventricular outflow tract obstruction defects 2.0, 1.4 to 3.1 and craniosynostosis 1.9, 1.1 to 3.0).

Conclusions: These data provide reassuring evidence for some SSRIs but suggest that some birth defects occur 2-3.5 times more frequently among the infants of women treated with paroxetine or fluoxetine early in pregnancy.