Twenty-five studies were included in the review (n=20,475 participants). Sample sizes ranged from 28 to 3,379. Eleven studies (n=8,859 participants) assessed the teratogenicity of paroxetine (seven prospective studies, three retrospective cohorts and one case-control study). Fourteen studies (n=11,616 participants) assessed the teratogenicity of selective serotonin reuptake inhibitors as a group (five prospective, four retrospective cohort and five case-control studies).
The included studies demonstrated a high degree of methodological variation, so the analyses were reported to be inconsistent and inconclusive. However, where relative risks and odds ratios were presented, several studies showed statistically significant results, with an increased risk of major foetal malformations. Paroxetine was associated with increased risks of foetal malformations as a whole, and (in particular) with risks of cardiac anomalies, ventricular outflow tract obstruction defects, anencephaly, gastroschisis, omphalocele, and eye defects.