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After initial reports of an association between paroxetine and heart defects, the US Food and Drug Administration published an advisory warning of this potential association in December 2005.1 Recent meta-analyses and systematic reviews combining data from more than 20 epidemiological studies have reached conflicting conclusions and this uncertainty influences perceptions of the safety of antidepressant use in pregnancy.2 3 In a recent study, 69% of women thought that it was definitely or probably acceptable to take such drugs when not pregnant or breast feeding, but only 33% of women thought that it was definitely or probably acceptable to do so when pregnant.4 SSRIs are increasingly used by women of reproductive age and during pregnancy, but the inconsistent reports have limited opportunities for clinicians to carefully evaluate the risk compared with benefit of specific SSRIs for a given patient during pregnancy.5 6 7 We reviewed the literature for any reports that assessed the relation between specific SSRIs and one or more of the specific birth defects that are also included in the US National Birth Defects Prevention Study (NBDPS).2 8 9 10 11 12 13 To provide a more robust estimate of the association between individual SSRIs and birth defects, information that is necessary for decision making by patients who are being treated with these drugs and their physicians, we used bayesian methods both to summarize independent findings identified in the literature and to update those findings using the entire set of data from the NBDPS.14 For this analysis we used data from the NBDPS, a population based case-control study of birth defects.The study’s methods have been described previously.15 16 17 Briefly, cases of birth defects were identified through birth defects surveillance systems in the US states of Arkansas, California, Georgia, Iowa, Massachusetts, New Jersey, New York, North Carolina, Texas, and Utah.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.The association between maternal use of antidepressants, especially selective serotonin reuptake inhibitors (SSRIs), during pregnancy and birth defects in the infants has been the topic of much discussion in recent years.An alternative approach to this analysis would be to develop estimates of the association between SSRI consumption and risk of birth defects using frequentist methods only focused on the 1997-2009 NBDPS data.These results could be summarized and then included as an additional point in a larger meta-analysis of available information.Some defects reported in other studies (for example, cystic kidney) could not be evaluated in this analysis because they were not included in NBDPS.13 A bayesian approach requires specification of prior distributions for each of the variables in the model used to estimate the potential association between risk of birth defect and use of SSRIs.
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).
The goal of the meta-analysis was to produce an estimate of the log odds ratio relating the specific birth defect and SSRI across studies, taking into account the study specific estimates and their associated sampling errors.
The assumed meta-analysis model included a term corresponding to the true underlying log odds ratio relating SSRI use and risk of birth defects and a collection of random study level effects.20 All available information was included in developing the meta-analysis based prior estimates, including results indicating no association between risk of birth defects and SSRI use from other published studies.