16/07/2024

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No Increase in Major Malformations in Children with Prenatal Exposure to Olanzapine

No Increase in Major Malformations in Children with Prenatal Exposure to Olanzapine

Despite the increasing use of the newer atypical or second-generation antipsychotic agents to treat a spectrum of psychiatric disorders, including psychotic disorders, bipolar disorder, major depression, PTSD and anxiety disorders, we have relatively little data on the reproductive safety of these newer atypical agents. In response to this deficit, the National Pregnancy Registry for Atypical Antipsychotics was created to evaluate the safety of atypical antipsychotic medications taken by women during pregnancy. In the most recent findings from the Registry, Dr. Adele Viguera and colleagues provide reassuring data on the use of olanzapine (Zyprexa) during pregnancy.

The National Pregnancy Registry for Atypical Antipsychotics is a prospective pharmacovigilance program in which pregnant women between the ages of 18 and 45 are enrolled during the first trimester of pregnancy and are interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm the presence or absence of major malformations. 

As of April 18, 2022, 2619 women have enrolled in the registry. At the time of data extraction, 49 olanzapine-exposed infants and 1156 unexposed infants in the comparison group were eligible for analysis in the current study. There were no major malformations associated with olanzapine exposure in the first trimester. The absolute risk for major malformations in the exposure group was 0.00% (95% confidence interval, 0.00-7.25) for olanzapine compared with 1.64% (95% confidence interval, 0.99-2.55) in the control group.

Preliminary Data is Reassuring 

In this prospective cohort study, no major malformations were associated with olanzapine exposure during the first trimester of pregnancy. Because this study included a relatively small number of exposures, these findings are preliminary and we cannot rule out more modest effects. However, this study adds to a growing body of literature supporting the reproductive safety of olanzapine. The registry will continue to collect data on pregnancies with exposure to olanzapine, as well as other atypical antipsychotic medications, in an effort to better characterize the effects of prenatal exposure to antipsychotic medications.

Those interested in finding out more or participating in the National Pregnancy Registry for Atypical Antipsychotics may contact the Registry  TOLL-FREE at 1-866-961-2388. In addition, those interested in participating may fill out this Patient Interest Form to be contacted by our research coordinator. All information is kept strictly confidential. Participation consists of three phone interviews.

Ruta Nonacs, MD PhD

Viguera AC, Freeman MP, Kobylski LA, Rossa ET, Gaccione P, Chitayat D, Hernández-Díaz S, Cohen LS. Risk of Major Malformations Following First-Trimester Exposure to Olanzapine: Preliminary Data From the Massachusetts General Hospital National Pregnancy Registry for Psychiatric Medications. J Clin Psychopharmacol. 2023 Feb 27.

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