BJOG. 2008 Jan;115(2):283-9.
Neonatal outcome following pregnancy exposure to antidepressants: a prospective
controlled cohort study.
Maschi S, Clavenna A, Campi R, Schiavetti B, Bernat M, Bonati M.
Laboratory for Mother and Child Health, "Mario Negri" Pharmacological Research
Institute, Milan, Italy.
Objectives:
To determine the incidence of early adverse effects associated with
antidepressant drug use during pregnancy.
Design:
Prospective, controlled cohort
study.
Setting:
A Drug and Health Information Centre in Milan, Italy.
POPULATION: A total of 200 neonates exposed to antidepressants in utero and 1200
controls.
Methods:
Women who took antidepressants during pregnancy and delivered
liveborn children between 1995 and 2003 were selected. Each case was matched for
maternal age and gravidity to six randomly selected controls (not exposed to
teratogenic drugs or drugs known to cause neonatal side effects). Odds ratio was
estimated for attributable risks.
Main Outcome Measures:
Neonatal adverse events
and Special Care Unit admission rate, assessed through an interview with the
mothers.
Results:
Of the 200 neonates exposed to antidepressants in utero, 14
had adverse events and 3 required Special Care Unit admission. Jaundice (n = 5),
agitation (n = 3) and respiratory distress (n = 2) were the most common
symptoms. In the control group, 50 newborns had side effects and no
statistically significant differences in the prevalence rate compared to the
exposed group were found, even after stratification for drugs and pregnancy
period of exposure. Only the prematurity rate was significantly higher in
exposed compared to non-exposed newborns (OR = 2.31; 95% CI 1.14-4.63).
Conclusions:
These results do not support an association between antidepressant
exposure and unsafe fetal and neonatal outcomes in newborns. However, a
collaborative international multicentre epidemiological monitoring of the use of
psychotropic drugs during pregnancy is needed in order to guarantee pregnant
women and their children safe and effective treatments, both at brief and long
time from exposure.
