New Research from the CWMH: No Increase in Major Malformations in Children Prenatally Exposed to Aripiprazole

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 other 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. The most recent findings on aripiprazole (Abilify) from the Registry were published earlier this month.

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 and interviewed during pregnancy and the postpartum period. Medical records are assessed to confirm the presence or absence of major malformations. As of April 2020, 848 women had delivered infants and were eligible for analysis. 

In this cohort, a total of 158 women reported  first trimester exposure to aripiprazole.  Among the 163 infants born to women with aripiprazole exposure, seven major malformations were identified (4.29%).  In a comparison group of 690 infants born to women psychiatric diagnoses but no exposure to atypical antipsychotic during pregnancy, 14 major malformations were identified (1.99%).  

The unadjusted odds ratio for major malformations in aripiprazole-exposed versus unexposed infants was 2.21 (95% confidence interval [CI] = (0.88 – 5.57); however, after controlling for potential confounders, the adjusted odds ratio for major malformations was 1.35 (95% confidence interval [CI] = (0.43 – 4.20). Thus, after adjusting for confounding variables, there was not a significant association between first trimester exposure to aripiprazole and increased risk for major malformations.  

While the preliminary data from this study is reassuring, larger numbers of participants are needed to provide more complete data regarding the reproductive safety of aripiprazole in particular, and for atypical antipsychotics as a class of medications.  These findings, taken together with other studies, suggest that prenatal exposure to atypical antipsychotics does not appear to significantly increase the risk for congenital malformation, although we have very few documented exposures to some of the newest atypicals, such as lurasidone (Latuda), iloperidone (Fanapt), brexpiprazole (Rexulti), and cariprazine (Vraylar).

The National Pregnancy Registry for Atypical Antipsychotics continues to recruit pregnant women taking atypical antipsychotic medications.   CALL TOLL-FREE to learn more 1-866-961-2388 or 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

Freeman MP, Viguera AC, Góez-Mogollón L, Young AV, Caplin PS, McElheny SA, Church TR, Chitayat D, Hernández-Díaz S, Cohen LS.  Reproductive safety of aripiprazole: data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics.  Arch Womens Ment Health. 2021 Mar 12. 

Leave a Reply

Your email address will not be published. Required fields are marked *