Pregnancy outcome of women using atypical antipsychotic drugs: a prospective comparative study

J Clin Psychiatry. 2005 Apr;66(4):444-9; quiz 546. doi: 10.4088/jcp.v66n0406.


Background: A substantial number of women of childbearing age suffer from schizophrenia and other mental illnesses that require the use of antipsychotic drugs. Atypical antipsychotics have been on the market since the mid-1990s, and to date there are no prospective comparative studies regarding use during pregnancy.

Objectives: (1) To determine whether atypical antipsychotics increase the rate of major malformations above the 1% to 3% baseline risk seen in the general population. (2) To examine rates of spontaneous and therapeutic abortions, rates of stillbirths, birth weight, and gestational age at birth.

Method: The cohort was composed of pregnant women who contacted the Motherisk Program in Canada or the Israeli Teratogen Information Service in Israel and women who were recruited from the Drug Safety Research Unit database in England. Women who had been exposed to atypical antipsychotics were matched to a comparison group of pregnant women who had not been exposed to these agents.

Results: Data were obtained on 151 pregnancy outcomes that included exposure to olanzapine (N= 60), risperidone (N = 49), quetiapine (N = 36), and clozapine (N = 6). Among women exposed to an atypical antipsychotic, there were 110 live births (72.8%), 22 spontaneous abortions (14.5%), 15 therapeutic abortions (9.9%), and 4 stillbirths (2.6%). Among babies of women in this group, there was 1 major malformation (0.9%), and the mean +/-SD birth weight was 3341 +/-685 g. There were no statistically significant differences in any of the pregnancy outcomes of interest between the exposed and comparison groups, with the exceptions of the rate of low birth weight, which was 10% in exposed babies compared with 2% in the comparison group (p = .05), and the rate of therapeutic abortions (p = .003).

Conclusion: These results suggest that atypical antipsychotics do not appear to be associated with an increased risk for major malformations.

Publication types

  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology
  • Abnormalities, Drug-Induced / etiology
  • Abortion, Induced / statistics & numerical data
  • Abortion, Spontaneous / chemically induced
  • Abortion, Spontaneous / epidemiology
  • Antipsychotic Agents / adverse effects*
  • Antipsychotic Agents / therapeutic use
  • Birth Weight / drug effects
  • Canada / epidemiology
  • England / epidemiology
  • Female
  • Gestational Age
  • Humans
  • Israel / epidemiology
  • Maternal Exposure / statistics & numerical data
  • Mental Disorders / drug therapy*
  • Mental Disorders / psychology
  • Pregnancy
  • Pregnancy Complications / drug therapy*
  • Pregnancy Outcome / epidemiology*
  • Pregnancy Trimester, First / drug effects
  • Prospective Studies
  • Risk Assessment
  • Schizophrenia / drug therapy


  • Antipsychotic Agents