Risk of Major Malformations Following First-Trimester Exposure to Cariprazine: Preliminary Data From the MGH National Pregnancy Registry for Psychiatric Medications

IF 3.9 2区医学 Q1 CLINICAL NEUROLOGY

Bipolar Disorders Pub Date : 2026-07-03 DOI:10.1111/bdi.70138

Adele C. Viguera, Marlene P. Freeman, Ella K. Slaby, Ana M. Manuelian, Peter Gaccione, David Chitayat, Sonia Hernández-Díaz, Lee S. Cohen

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引用次数: 0

Abstract

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 second-generation antipsychotic medications.

Results

As of September 9, 2025, N = 4,125 have enrolled in the study. Of those enrolled, 58 cariprazine-exposed infants and 2,098 infants in the comparison group were eligible for inclusion in this analysis. 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

In this prospective cohort, 0 of 58 infants exposed to cariprazine during the first trimester had major malformations, compared with 32 of 2,098 (1.53%) unexposed infants. 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.

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妊娠早期暴露于卡吡嗪后的主要畸形风险：来自MGH国家妊娠登记精神病药物的初步数据。

目的：尽管卡吡嗪在精神病适应症中的应用越来越广泛，但缺乏系统收集的卡吡嗪妊娠安全性数据。该分析的目的是确定患有精神疾病的母亲在怀孕前三个月使用卡吡嗪的婴儿与未使用卡吡嗪的对照组相比发生重大畸形的风险。方法：国家精神药物妊娠登记（NPRPM）是一项前瞻性药物警戒计划，在该计划中，诊断为精神疾病的孕妇在怀孕期间登记并随访至产后。劳动和分娩和儿科医疗记录审查的证据，主要畸形随后由畸形学家对药物暴露的最终裁决。孕早期暴露于卡吡嗪的婴儿与未暴露于第二代抗精神病药物的对照组进行比较。结果：截至2025年9月9日，N = 4125人入组研究。在纳入的研究中，58名卡吡嗪暴露婴儿和2098名对照组婴儿符合纳入本分析的条件。卡吡嗪暴露组未发生重大畸形（绝对风险0.00%，95%可信区间0.00% ~ 6.16%），对照组32例发生重大畸形（绝对风险1.53%，95%可信区间1.05% ~ 2.15%）。结论：在这一前瞻性队列研究中，在妊娠早期暴露于卡吡嗪的58名婴儿中有0名患有严重畸形，而未暴露于卡吡嗪的2098名婴儿中有32名（1.53%）患有严重畸形。虽然这些数据是初步的，不能排除适度的致畸作用，但它们对向卫生保健提供者和公众提供仍然很重要，因为在育龄妇女中使用卡吡嗪的人数一直在上升。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bipolar Disorders 医学-精神病学

CiteScore

8.20

自引率

7.40%

发文量

审稿时长

6-12 weeks

期刊介绍： Bipolar Disorders is an international journal that publishes all research of relevance for the basic mechanisms, clinical aspects, or treatment of bipolar disorders and related illnesses. It intends to provide a single international outlet for new research in this area and covers research in the following areas: biochemistry physiology neuropsychopharmacology neuroanatomy neuropathology genetics brain imaging epidemiology phenomenology clinical aspects and therapeutics of bipolar disorders Bipolar Disorders also contains papers that form the development of new therapeutic strategies for these disorders as well as papers on the topics of schizoaffective disorders, and depressive disorders as these can be cyclic disorders with areas of overlap with bipolar disorders. The journal will consider for publication submissions within the domain of: Perspectives, Research Articles, Correspondence, Clinical Corner, and Reflections. Within these there are a number of types of articles: invited editorials, debates, review articles, original articles, commentaries, letters to the editors, clinical conundrums, clinical curiosities, clinical care, and musings.