Paroxetine and congenital malformations: meta-analysis and consideration of potential confounding factors Bar-Oz B, Einarson T, Einarson A, Boskovic R, O'Brien L, Malm H, Berard A, Koren G CRD summary This review investigated whether first-trimester exposure to paroxetine is associated with an increased risk of congenital malformations. The authors concluded that first trimester exposure to paroxetine appears to be associated with a significant increase in the risk of cardiac malformation. However, the reliability of these conclusions is unclear as insufficient details of the included studies were provided. Authors' objectives To investigate whether first-trimester exposure to paroxetine is associated with an increased risk of congenital malformations. Searching MEDLINE, EMBASE, REPROTOX, Scopus and Biological Abstracts were searched from 1985 to 2006; the search terms were reported. Reference lists of retrieved studies, proceedings from meetings of professional societies, textbooks and Internet websites were also checked for additional articles. No language restrictions were applied. Study selection Study designs of evaluations included in the review Case-control and cohort studies (prospective and retrospective) were eligible for inclusion as long as both groups were drawn from the same population. Experimental studies and case reports were excluded. The included studies were of the following designs: nested case-control, prospective controlled, population-based cohort, retrospective cohort and prospective recording-registry. Specific interventions included in the review Studies that examined the effects of exposure to paroxetine were eligible for inclusion. The control groups consisted of women using antidepressants other than paroxetine, or other non-teratogenic medications. Participants included in the review Studies of women in the first trimester of pregnancy (0 to 14 weeks' gestation) were eligible for inclusion. Outcomes assessed in the review Studies that reported on the number of major congenital malformations and/or the number of cardiac congenital malformations were eligible for inclusion. Outcomes were only considered for live births. How were decisions on the relevance of primary studies made? Two reviewers independently selected studies for inclusion. Any discrepancies were resolved using a third reviewer. Assessment of study quality The quality of the included studies was assessed using a 27-item scale based on a published checklist, with a summary quality score based on the percentage of items fulfilled. The authors did not state how many reviewers performed the quality assessment. Data extraction Two reviewers independently extracted data on the number of infants born with and without malformations in the Database of Abstracts of Reviews of Effects (DARE) Produced by the Centre for Reviews and Dissemination Copyright © 2017 University of York Page: 1 / 3