Given the number of younger women using atypical or second-generation antipsychotic medications, there is an urgent need for more accurate data regarding the reproductive safety of these medications. Thus far, studies have not documented an increased risk of malformations among women using newer antipsychotic medications during pregnancy; however, the information on the reproductive safety of this class of medications is limited and we lack data on certain, less commonly used antipsychotic medications, such as lurasidone (Latuda) and cariprazine (Vraylar). 

A new study has examined outcomes in pregnant women who received consultations regarding drug exposure from the Japan Drug Information Institute in Pregnancy between October 2005 and December 2016. These individuals were asked to complete a questionnaire one month after the expected delivery date. This questionnaire included self-reported information on medication use during pregnancy, pregnancy outcomes, date of delivery, and gestational age at delivery.  Reported congenital malformations were confirmed using the pediatrician’s report, and the following parameters were also collected from the medical record: infant height, weight, head circumference, and chest circumference at birth. Odds ratios (ORs) for major congenital malformations among live-born children were calculated, comparing children with exposure to SGAs during the first trimester (SGA group, n=404) to children of women with no exposure to SGAs or to medications known to be teratogenic (comparison group).

In this cohort of 404 women with first trimester exposure to SGAs, 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 out of 351) in the SGA group and 1.8% (70 out of 3,899) in the comparison group. No statistically significant differences were observed in the adjusted odds ratio for major congenital malformations (adjusted OR = 0.44; 95% CI, 0.12-1.48; P = 0.179).

The major strength of this study is that it was conducted prospectively, which decreases the likelihood of reporting and recall biases. In addition, the presence of major malformations was confirmed using pediatric records. While these findings are reassuring and are consistent with previous studies, our information regarding the use of these medications during pregnancy is still limited. In an accompanying commentary, Dr. Adele Viguera notes that women who contact a teratogen information service regarding the use of a particular medication may not be representative of the general population; they may be better educated and higher functioning and may thus have better outcomes.

The National Pregnancy Registry for Atypical Antipsychotic Medications

Because the data available regarding the use of atypical or second generation antipsychotic medications in pregnancy is sparse, there is a great need to study these medications and their use in pregnancy. The National Pregnancy Registry for Atypical Antipsychotics is currently enrolling pregnant patients taking atypical antipsychotic medications to learn more about reproductive safety of these medications. Those interested in the study may call TOLL-FREE: 1-866-961-2388.


Yakuwa N, Takahashi K, Anzai T, Ito N, Goto M, Koinuma S, Uno C, Suzuki T, Watanabe O, Yamatani A, Murashima A. Pregnancy Outcomes With Exposure to Second-Generation Antipsychotics During the First Trimester. J Clin Psychiatry. 2022 Jun 8;83(4):21m14081. 


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