OBJECTIVE: 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.
OBJECTIVE: 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.