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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. 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 19.
Overall participation was 67.4% for cases and 64.8% for controls.
A previous NBDPS analysis of the association between SSRI use during pregnancy and birth defects, included in table 1 as Alwan and colleagues, included data from 1997 to 2002.8 To avoid double counting, these NBDPS data were excluded from the meta-analyses used to calculate prior odds ratios in the current study, but we used significant findings from the previous analysis along with those of the other studies listed in table 1 to determine which birth defect-SSRI combinations to assess. For this analysis, we considered women exposed if they reported taking citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil), or sertraline (Zoloft) at least once in the period from one month before conception through the third month of pregnancy.
After ascertainment in population based surveillance systems, the diagnostic information was reviewed by clinical geneticists at each site to establish eligibility.
Designated individual clinical geneticists reviewed all cases with a particular defect to ensure consistency across sites.16 Because the primary intent of this analysis was to assess previously reported associations with SSRIs and to determine if those associations were supported by NBDPS data, we included only outcomes with at least one previous report in the peer reviewed literature suggesting a possible association with SSRIs: neural tube defects (international classification of diseases, ninth revision (ICD-9): 740-742.0), anencephaly (ICD-9: 740), all septal defects (ICD-9: 745), ventricular septal defects (ICD-9: 745.4), right ventricular outflow tract obstructions (ICD-9: 746.0-746.1), cleft palate (ICD-9: 749.0), cleft lip with or without cleft palate (ICD-9: 749.2-749.4), esophageal atresia (ICD-9: 750.3), anal atresia (ICD-9: 751.23-751.24), hypospadias (ICD-9: 752.6), any limb reduction defect (ICD-9: 755.2), craniosynostosis (ICD-9: 756.0), gastroschisis (ICD-9: 756.71), and omphalocele (ICD-9: 756.70).
Prior distributions were developed based on literature review.We chose the bayesian approach for two primary reasons.Firstly, we viewed the collection of information summarized by the meta-analysis as the state of current knowledge concerning potential association between SSRIs and risk of birth defects and the NBDPS data as new information available to update that knowledge.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.