A systematic review of maternal and infant outcomes after clozapine continuation in pregnancy

Int J Psychiatry Clin Pract. 2022 Jun;26(2):178-182. doi: 10.1080/13651501.2021.1936070. Epub 2021 Jun 10.


Objective: While there is a general lack of evidence of the safety of antipsychotic medications in pregnancy, there is a specific reluctance to continue clozapine in treatment resistant patients who become pregnant. Our aim is to systematically review adverse maternal and infant outcomes following clozapine use during pregnancy.

Method: A systematic review of all observational and intervention studies which highlighted adverse maternal and infant outcomes following clozapine continuation in pregnancy was undertaken. Article selection and quality were independently assessed and PRISMA guidelines adhered to.

Results: Of 481 studies identified only two studies met the inclusion criteria. Both were rated as poor quality. The first found no significant increase in any adverse maternal or infant outcomes associated with antipsychotic exposure, except an increased rate of low birth weight in antipsychotic exposed babies. The number of patients exposed to clozapine was too small for separate statistical analysis. The second study found higher APGAR scoring at one minute for the clozapine group, but the scores were not statistically different at five-minutes.

Conclusion: Limited evidence was found to show significant adverse maternal and infant outcomes in pregnancy following clozapine continuation.Key messagesLimited evidence to show that clozapine has adverse effects on mother and infant when used during pregnancy.Risk/benefit analysis should be done thoroughly for each individual patient regarding clozapine continuation when pregnancy is confirmed.Close monitoring of mother and infant during perinatal period when clozapine is continued.Further research is needed to more clearly define the effects of clozapine on mother and infant during pregnancy and into the postnatal period.

Keywords: clozapine in pregnancy treatment resistant schizophrenia perinatal psychiatry; psychopharmacology foetal outcomes systematic review.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Antipsychotic Agents*
  • Clozapine*
  • Female
  • Humans
  • Infant
  • Pregnancy


  • Antipsychotic Agents
  • Clozapine