This is the first part of a two part series on the use of antipsychotic medications during pregnancy.

Atypical antipsychotic medications are commonly used for the treatment of schizophrenia and bipolar disorder. Despite the increasing use of these medications in women of child-bearing age, there is still relatively little data regarding the reproductive safety and long-term neurodevelopmental effects of these medications.

The Australian National Register of Antipsychotic Medication in Pregnancy (NRAMP) was established in 2005 as an ongoing prospective observational cohort study (Clinical trials number NCT00686946). Pregnant women taking antipsychotic medications (mostly newer atypical agents) were recruited during pregnancy or in the first 12 months after birth. Information on exposures and pregnancy outcomes was collected from the mother and, when possible, from the treating clinicians and medical records.

The first report from the registry reported on a total of 147 pregnancies. The most commonly used agents were quetiapine (n=74), olanzapine (n=24), aripiprazole (n=19), and risperidone (n=15). There were 142 live births, and data were available for 100 children at one year of age.

  • The reported rate of gestational diabetes was high at 22%.
  • 18% of babies were born prematurely, with higher doses of antipsychotic medication correlating with an increased likelihood of premature delivery.
  • 43% of babies required special care nursery or intensive care after birth; many of these infants were also exposed to other psychotropic medications, including mood stabilizers.
  • Congenital anomalies were seen in 8 out of 142 infants (5.6%).

This study did not have an unexposed control group. For comparison, the researchers compared their data with expected rates of the various outcomes in Australia. One of the problems with using this comparison group is that women with schizophrenia and bipolar disorders have higher rates of adverse events (including preterm birth, low birth weight, and admission to the special care nursery) even in the absence of medication exposure.

As we advise our patients regarding the use of this class of medications, we cannot simply say that atypical antipsychotics are “safe”; instead, we must inform our patients of the limitations of the data we do have. Based on the existing data, we cannot definitively rule out the possibility that there is some increase in risk for malformation. Nor can we say much about some of the newer atypicals, such as lurasidone and ziprasidone, which were underrepresented in this study. Furthermore, we must take into consideration the indication for the usage of the antipsychotic medication. For example, we would be more likely to maintain the use of an atypical antipsychotic in a patient with schizophrenia than in a patient who is using a low dose of an atypical agent to manage insomnia.

The National Pregnancy Registry for Atypical Antipsychotics is dedicated to evaluating the safety of atypical antipsychotic medications that may be taken by women during pregnancy. The goal of this Registry is to gather information on the safety of these medications during pregnancy, as current data is inconclusive. CALL TOLL-FREE to learn more: 1-866-961-2388 or email at

We are recruiting pregnant women aged 18-45 years who are treated with one or more atypical antipsychotics, and prospectively following them for a spectrum of outcomes, including organ malformations and maternal or newborn complications. These drugs include aripiprazole (Abilify), clozapine (Clozaril), ziprasidone (Geodon), paliperidone (Invega), risperidone (Risperdal), quetiapine (Seroquel), olanzapine (Zyprexa), asenapine (Saphris), lurasidone (Latuda), and Iloperidone (Fanapt).

In Part 2 of this series, we will present preliminary data from the MGH Pregnancy Registry which was presented at this year’s Annual Meeting of the American Society of Clinical Psychopharmacology.

Ruta Nonacs, MD PhD

Kulkarni J, Worsley R, Gilbert H, Gavrilidis E, Van Rheenen TE, Wang W, McCauley K, Fitzgerald P. A Prospective Cohort Study of Antipsychotic Medications in Pregnancy: The First 147 Pregnancies and 100 One Year Old Babies. PLoS One. 2014 May 2; 9(5): e94788.


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