Does Paroxetine Cause Cardiac Malformations?

• Published in: Journal of obstetrics and gynaecology Canada Vol. 30; no. 8; pp. 696 - 701
• Main Authors: O’Brien, Lisa, MSc, Einarson, Thomas R., PhD, Sarkar, Moumita, MSc, Einarson, Adrienne, RN, Koren, Gideon, MD
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Inc 01.08.2008
• Subjects: cardiac malformation; Case-Control Studies; Cohort Studies; Drug-Related Side Effects and Adverse Reactions; Female; Heart Defects, Congenital - chemically induced; Heart Defects, Congenital - epidemiology; Humans; Obstetrics and Gynecology; Paroxetine; Paroxetine - adverse effects; Pregnancy; Pregnancy Trimester, First; Serotonin Uptake Inhibitors - adverse effects; Paroxetine; cardiac malformation; pregnancy
• ISSN: 1701-2163
• DOI: 10.1016/S1701-2163(16)32918-8

Abstract 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.