Women of childbearing age are often affected with psychotic disorders, requiring the use of antipsychotic medication during pregnancy. In the present study, we prospectively followed the pregnancies of 561 women exposed to second-generation antipsychotic agents (SGAs; study cohort) and compared these to 284 pregnant women exposed to first-generation antipsychotic agents (FGAs; comparison cohort I) and to 1122 pregnant women using drugs known as not harmful to the unborn (comparison cohort II). Subjects were enrolled through the Institute’s consultation service. Major malformation rates of SGA exposed were higher compared to comparison cohort II (adjusted odds ratio, 2.17; 95% confidence interval, 1.20–3.91), possibly reflecting a detection bias concerning atrial and ventricular septal defects. Postnatal disorders occurred significantly more often in infants prenatally exposed to SGAs (15.6%) and FGAs (21.6%) compared to 4.2% of comparison cohort II. Cumulative incidences of elective terminations of pregnancy were significantly higher in both the study cohort (17%) and comparison cohort I (21%) compared to comparison cohort II (3%), whereas the rates of spontaneous abortions did not differ. The numbers of stillbirths and neonatal deaths were within the reference range. Preterm birth and low birth weight were more common in infants exposed to FGAs. To conclude, our findings did not reveal a major teratogenic risk for SGAs, making the better studied drugs of this group a treatment option during pregnancy. Because neonates exposed to SGAs or FGAs in the last gestational week are at higher risk of postnatal disorders, delivery should be planned in clinics with neonatal intensive care units.
From the *Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité Universitätsmedizin Berlin; †Beuth Hochschule für Technik – University of Applied Sciences, Berlin; ‡Freiburg Center for Data Analysis and Modeling, University of Freiburg; and §Institute for Medical Biometry and Medical Informatics, University Medical Center, Freiburg, Germany.
Received June 4, 2012; accepted after revision December 5, 2012.
Reprints: Christof Schaefer, MD, PhD, Institute for Clinical Pharmacology and Toxicology, Charité Universitätsmedizin Berlin, Spandauer Damm 130, Haus 10, D-14050 Berlin, Germany (e-mail: email@example.com).
The authors received funding from the German Federal Ministry of Health (F.H., J.F., E.W., C.W.-S., and C.S.).