Does Paroxetine Cause Cardiac Malformations?

Background: Debate has recently arisen about the safety of paroxetine use in pregnancy, prompted by reports of increased risks for cardiac defects following first trimester exposure. Methods: We conducted a meta-analysis of nine studies. Results: Three case-control studies (N = 30 247) found no increased risk of congenital malformations associated with paroxetine (OR = 1.18; 95% CI 0.88-1.59). Cardiac malformation rates were similar (1.1% each) and within population norms (0.7-1.2%). Six cohort studies (N = 66 409) found a non-significant weighted average difference of 0.3% (95% CI -0.1-0.7%; P = 0.19). Conclusion: First-trimester exposure to paroxetine does not appear to be associated with increased rates of cardiac malformations. This information should be reassuring to prescribing physicians and women who require treatment with paroxetine in pregnancy.