title: Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study.
abstract: 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.
authors.affiliation: Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: Frank
authors.initials: F
authors.lastname: Habermann
authors.forename: Juliane
authors.initials: J
authors.lastname: Fritzsche
authors.forename: Frederike
authors.initials: F
authors.lastname: Fuhlbrück
authors.forename: Evelin
authors.initials: E
authors.lastname: Wacker
authors.forename: Arthur
authors.initials: A
authors.lastname: Allignol
authors.forename: Corinna
authors.initials: C
authors.lastname: Weber-Schoendorfer
authors.forename: Reinhard
authors.initials: R
authors.lastname: Meister
authors.forename: Christof
authors.initials: C
authors.lastname: Schaefer
mesh_terms: D000014:Abnormalities, Drug-Induced / Q000209:etiology / Q000401:mortality; D000028:Abortion, Induced; D000022:Abortion, Spontaneous / Q000139:chemically induced / Q000401:mortality; D000328:Adult; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000145:classification / Q000627:therapeutic use*; D016022:Case-Control Studies; D005260:Female; D005865:Gestational Age; D006801:Humans; D007223:Infant; D007226:Infant Mortality; D007230:Infant, Low Birth Weight; D007231:Infant, Newborn; D016015:Logistic Models; D016017:Odds Ratio; D011247:Pregnancy; D011248:Pregnancy Complications / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D047928:Premature Birth; D011297:Prenatal Exposure Delayed Effects; D011446:Prospective Studies; D011618:Psychotic Disorders / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D018570:Risk Assessment; D012307:Risk Factors; D050497:Stillbirth; D016896:Treatment Outcome
chemical_list: D014150:Antipsychotic Agents