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Original Research

Pregnancy Outcomes With Exposure to Second-Generation Antipsychotics During the First Trimester

Naho Yakuwa, BPharma,b,*; Kunihiko Takahashi, PhDc; Tatsuhiko Anzai, PhDc; Naoki Ito, MD, PhDa,d; Mikako Goto, MD, PhDa; Sachi Koinuma, MDa; Chiaki Uno, BPharma,e; Tomo Suzuki, MDa,f; Omi Watanabe, MDa; Akimasa Yamatani, PhDa,e; and Atsuko Murashima, MD, PhDa,f

Published: June 8, 2022


Objective: To investigate the risk of major congenital malformations associated with exposure to second-generation antipsychotics (SGAs) in the first trimester.

Methods: Pregnant women who received consultation on drug exposure from the Japan Drug Information Institute in Pregnancy from October 2005 to December 2016 were asked to complete a questionnaire at 1 month after the expected delivery date. The questionnaire included items on pregnancy outcome, date of delivery, gestational age at delivery, malformations in the infant that were confirmed by the pediatrician’s report, and the following parameters at birth: height, weight, head circumference, and chest circumference. Odds ratios (ORs) for major congenital malformations among live-born children of pregnant women with SGA exposure during the first trimester (SGA group) relative to children of women not exposed to SGAs and medications known to be teratogenic (comparison group) were estimated using an inverse probability of treatment weighting approach.

Results: Of 404 women with SGA exposure during the first trimester, there were 351 live births, 3 stillbirths, 34 spontaneous abortions, and 16 elective abortions. The rate of major congenital malformations among live-born children was 0.9% (3/351) in the SGA group and 1.8% (70/3,899) in the comparison group. No statistically significant differences were observed in the adjusted OR for major congenital malformations (adjusted OR = 0.44; 95% CI, 0.12–1.48; P = .179).

Conclusions: SGA exposure during the first trimester is not associated with an increased risk of major congenital malformations. These findings might be reassuring for pregnant women who require SGAs.

Volume: 83

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