Risk of Major Congenital Malformations Associated With the First-Trimester Exposure to Antipsychotics: A Large Claims...

Area of Science:

• Pharmacovigilance
• Reproductive Toxicology
• Maternal-Fetal Medicine

Background:

• Antipsychotic medications are frequently prescribed for psychiatric disorders during pregnancy.
• Understanding the potential risks of these medications, particularly for major congenital malformations (MCMs), is crucial for informed clinical decision-making.

Purpose of the Study:

• To evaluate the association between first-trimester antipsychotic exposure and the risk of major congenital malformations (MCMs) in infants.
• To assess this risk in a large cohort of pregnant women using a Japanese claims database.

Main Methods:

• A retrospective cohort study utilizing a Japanese claims database (2010-2019).
• Pregnancy onset and delivery dates were estimated algorithmically.
• Major congenital malformations (MCMs) were identified using ICD-10 codes.
• Propensity-score overlap weights were used to adjust for confounding by indication in women with psychiatric disorders.

Main Results:

• The study included 91,390 deliveries; 6,291 women had psychiatric diagnoses before the end of the first trimester.
• Among these, 317 were exposed to antipsychotics in the first trimester.
• The prevalence of MCMs was 6.9% in unexposed and 7.6% in exposed infants.
• First-trimester antipsychotic exposure was not significantly associated with overall MCMs (wOR 1.144, 95% CI 0.727-1.799).

Conclusions:

• First-trimester exposure to antipsychotics was not associated with an increased risk of overall major congenital malformations.
• These findings contribute to the safety profile of antipsychotic use during early pregnancy.