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A Prospective Controlled Multicenter Study

Nathalie A. Kulin, MSc; Anne Pastuszak, MSc; Suzanne R. Sage, RN, MS; Betsy Schick-Boschetto, MSN; Glenda Spivey, MS, CT; Marcia Feldkamp; Kelly Ormond, MS; Doreen Matsui, MD; Amy K. Stein-Schechman, MS; Lola Cook, MS; Joanne Brochu; Michael Rieder, MD; Gideon Koren, MD

JAMA. 1998;279:609-610.

Context.— Although a large number of women of reproductive age use new selective serotonin reuptake inhibitors (SSRIs) and half of all pregnancies are unplanned, no data exist on the safety of these agents for the human fetus.

Objective.— To assess fetal safety and risk of fluvoxamine, paroxetine, and sertraline.

Design.— A prospective, multicenter, controlled cohort study.

Setting.— Nine Teratology Information Service centers in the United States and Canada.

Patients.— All women who were counseled during pregnancy following exposure to a new SSRI and followed up by the participating centers. Controls were randomly selected from women counseled after exposure to nonteratogenic agents.

Main Outcome Measures.— Rates of major congenital malformations.

Results.— A total of 267 women exposed to an SSRI and 267 controls were studied. Exposure to SSRIs was not associated with either increased risk for major malformations (9/222 live births [4.1%] vs 9/235 live births [3.8%] in the controls, relative risk, 1.06, 95% confidence interval, 0.43-2.62) or higher rates of miscarriage, stillbirth, or prematurity. Mean (SD) birth weights among SSRI users (3439 [505] g) were similar to the controls (3445 [610] g) as were the gestational ages (39.4 [1.7] weeks vs 39.4 [1.9] weeks).

Conclusion.— The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.

From The Motherisk Program, The Hospital for Sick Children, and the University of Toronto, Toronto, Ontario (Mss Kulin and Pastuszak and Dr Koren); Teratogen Information Service, Tampa, Fla (Ms Sage); Pregnancy Healthline at Pennsylvania Hospital, Philadelphia (Ms Schick-Boschetto); Connecticut Pregnancy Exposure Information Service, Farmington, Conn (Mss Spivey and Brochu); Pregnancy Riskline, Salt Lake City, Utah (Ms Feldkamp); Department of Pediatrics, University of Vermont, College of Medicine, Burlington (Ms Ormond); FRAME Program, London, Ontario (Drs Matsui and Rieder); Illinois Teratogen Information Service, Chicago, Ill (Ms Stein-Schechman); and Indiana Teratogen Information Service, Indianapolis, Ind (Ms Cook).

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