RISK OF MAJOR MALFORMATIONS FOLLOWING FIRST TRIMESTER EXPOSURE TO CARIPRAZINE: PRELIMINARY DATA FROM THE MGH NATIONAL PREGNANCY REGISTRY FOR PSYCHIATRIC MEDICATIONS

Objective

Systematically collected pregnancy safety data for cariprazine have been lacking, despite growing use of this medication across psychiatric indications. The goal of this analysis was to determine the risk of major malformations among infants of mothers with psychiatric illness who used cariprazine during the first trimester of pregnancy compared to unexposed controls.

Methods

The National Pregnancy Registry for Psychiatric Medications (NPRPM) is a prospective pharmacovigilance program in which pregnant women with psychiatric diagnoses are enrolled during pregnancy and followed through the postpartum period. Labor and delivery and pediatric medical records are reviewed for evidence of major malformations followed by final adjudication by a dysmorphologist blinded to medication exposure. Infants with first-trimester exposure to cariprazine were compared to controls not exposed to secondgeneration antipsychotic medications.

Results

As of September 9, 2025, N=4125 have enrolled in the study. Of those enrolled, 58 cariprazine-exposed infants and 2098 infants in the comparison group were eligible for inclusion in analyses. There were no major malformations in the cariprazine-exposed group (absolute risk 0.00%; 95% confidence interval, 0.00–6.16%) compared to 32 infants with major malformations in the control group (1.53%; 1.05-2.15%).

Conclusions

This prospective cohort shows that 0/58 infants in the group exposed to cariprazine in the first trimester had major malformations compared to 32/2098 who were not exposed. Although these data are preliminary and cannot rule out modest teratogenic effects, they are nonetheless important to provide to health care providers and the public, as cariprazine use has been rising among women of reproductive age.