Pregnancy outcome following maternal use of the new selective serotonin reuptake inhibitors: a prospective controlled multicenter study.
BACKGROUND
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.


METHODS
A prospective, multicenter, controlled cohort study.


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


METHODS
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.


METHODS
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).


CONCLUSIONS
The new SSRIs, fluvoxamine, paroxetine, and sertraline, do not appear to increase the teratogenic risk when used in their recommended doses.
Kulin
N A
NA
The Motherisk Program, The Hospital for Sick Children, and the University of Toronto, Ontario, Canada.
Pastuszak
A
A
Sage
S R
SR
Schick-Boschetto
B
B
Spivey
G
G
Feldkamp
M
M
Ormond
K
K
Matsui
D
D
Stein-Schechman
A K
AK
Cook
L
L
Brochu
J
J
Rieder
M
M
Koren
G
G
D015057:1-Naphthylamine / Q000009:adverse effects / Q000031:analogs & derivatives; D000014:Abnormalities, Drug-Induced / Q000209:etiology*; D000328:Adult; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D015331:Cohort Studies; D005260:Female; D016666:Fluvoxamine / Q000009:adverse effects; D006801:Humans; D007231:Infant, Newborn; D017374:Paroxetine / Q000009:adverse effects; D011247:Pregnancy; D011256:Pregnancy Outcome; D011261:Pregnancy Trimester, First; D011446:Prospective Studies; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects* / Q000627:therapeutic use; D020280:Sertraline
D015057:1-Naphthylamine; D000928:Antidepressive Agents; D016666:Fluvoxamine; D017374:Paroxetine; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline