Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study

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 thes...

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Published inJournal of clinical psychopharmacology Vol. 33; no. 4; p. 453
Main Authors Habermann, Frank, Fritzsche, Juliane, Fuhlbrück, Frederike, Wacker, Evelin, Allignol, Arthur, Weber-Schoendorfer, Corinna, Meister, Reinhard, Schaefer, Christof
Format Journal Article
LanguageEnglish
Published United States 01.08.2013
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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.
AbstractList 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.
Author Schaefer, Christof
Habermann, Frank
Allignol, Arthur
Weber-Schoendorfer, Corinna
Meister, Reinhard
Fritzsche, Juliane
Fuhlbrück, Frederike
Wacker, Evelin
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  surname: Habermann
  fullname: Habermann, Frank
  organization: Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy, Charité Universitätsmedizin Berlin, Berlin, Germany
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  givenname: Juliane
  surname: Fritzsche
  fullname: Fritzsche, Juliane
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  givenname: Frederike
  surname: Fuhlbrück
  fullname: Fuhlbrück, Frederike
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  givenname: Evelin
  surname: Wacker
  fullname: Wacker, Evelin
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  surname: Allignol
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  givenname: Corinna
  surname: Weber-Schoendorfer
  fullname: Weber-Schoendorfer, Corinna
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  surname: Meister
  fullname: Meister, Reinhard
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  givenname: Christof
  surname: Schaefer
  fullname: Schaefer, Christof
BackLink https://www.ncbi.nlm.nih.gov/pubmed/23764684$$D View this record in MEDLINE/PubMed
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Snippet Women of childbearing age are often affected with psychotic disorders, requiring the use of antipsychotic medication during pregnancy. In the present study, we...
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StartPage 453
SubjectTerms Abnormalities, Drug-Induced - etiology
Abnormalities, Drug-Induced - mortality
Abortion, Induced
Abortion, Spontaneous - chemically induced
Abortion, Spontaneous - mortality
Adult
Antipsychotic Agents - adverse effects
Antipsychotic Agents - classification
Antipsychotic Agents - therapeutic use
Case-Control Studies
Female
Gestational Age
Humans
Infant
Infant Mortality
Infant, Low Birth Weight
Infant, Newborn
Logistic Models
Odds Ratio
Pregnancy
Pregnancy Complications - diagnosis
Pregnancy Complications - drug therapy
Pregnancy Complications - psychology
Premature Birth
Prenatal Exposure Delayed Effects
Prospective Studies
Psychotic Disorders - diagnosis
Psychotic Disorders - drug therapy
Psychotic Disorders - psychology
Risk Assessment
Risk Factors
Stillbirth
Treatment Outcome
Title Atypical antipsychotic drugs and pregnancy outcome: a prospective, cohort study
URI https://www.ncbi.nlm.nih.gov/pubmed/23764684
Volume 33
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