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Largest study to date shows overall use of antipsychotics in pregnancy does not appear to significantly increase the risk of congenital malformations
  1. Sophie Grigoriadis,
  2. Miki Peer
  1. Department of Psychiatry, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
  1. Correspondence to Sophie Grigoriadis, Department of Psychiatry, Sunnybrook Health Sciences Centre, 2075 Bayview Ave, FG29, Toronto, ON, Canada M4N 3M5; sophie.grigoriadis{at}

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ABSTRACT FROM: Huybrechts KF, Hernández-Díaz S, Patorno E, et al. Antipsychotic use in pregnancy and the risk for congenital malformations. JAMA Psychiatry 2016;73:938–46.

What is already known on this topic

Atypical and typical antipsychotics (APs) are used to treat bipolar and psychotic disorders, and atypicals are increasingly used off-label to treat other disorders.1 With the rise of their use during pregnancy, we are increasingly in need of high-quality data to rely on for treatment recommendations as data from randomised controlled trials (RCT) are not available. Previous research on whether APs are associated with an increased risk of congenital malformations (CMs) has not yielded consistent findings and has relied on a small number of exposures.2–4 Given the small baseline risk for CMs in the general population and the large number of potential confounders, very large sample sizes are needed in observational studies assessing the link between APs and CMs.

Methods of the study

Data were collected from the pregnancy cohort nested in the Medicaid Analytic Extract Database, where all pregnancies with live births for women aged 12–55 (1 January 2000 to 31 December 2010) were included, resulting in a cohort of 1.3 million pregnant women. Filling at least one prescription …

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  • Competing interests SG reports personal fees from Pfizer, personal fees from Actavis/Allergan, personal fees from Sage, outside the submitted work. MP has no competing interests to declare.

  • Provenance and peer review Commissioned; internally peer reviewed.