"Quetiapine Use During First Trimester Does Not Increase Risk of Major Birth Defects, Study Suggests"

August 21, 2018

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Use of the antipsychotic quetiapine during the first trimester of pregnancy does not appear to increase the risk for major malformations in offspring, according to a report published yesterday in AJP in Advance.

“Given the considerable use of quetiapine among women of reproductive age across multiple indications, it is critical to have better information regarding the potential risks of fetal exposure to this medication so that women can make informed treatment decisions consistent with their personal wishes and the severity of their underlying psychiatric disorder,” wrote Lee Cohen, M.D., of Harvard Medical School and colleagues. “The study results suggest that quetiapine is not a major teratogen.”

To quantify the relative risk of major malformations associated with first-trimester exposure to quetiapine compared with women with psychiatric disorders not taking second-generation antipsychotics, Cohen and colleagues analyzed data from the National Pregnancy Registry for Atypical Antipsychotics. As part of participation in the registry, pregnant women aged 18 to 45 with a history of psychiatric illness were interviewed across pregnancy and the early postpartum period by telephone. Obstetric, labor, and delivery medical records and pediatric medical records from the first six months of life were screened for evidence of major malformations.

For the analysis, 155 infants (including three sets of twins) exposed to quetiapine during the first trimester were compared with 210 infants born in the unexposed group (including five sets of twins). Two major malformations (1.2%) were confirmed among infants exposed to quetiapine compared with three (1.4%) major malformations among infants who were not exposed to second-generation antipsychotics. 

“These findings represent preliminary yet important data with profound clinical implications for pregnant women and women of reproductive potential,” Cohen and colleagues wrote. “It is imperative that research efforts continue to focus on the reproductive safety of psychiatric medications that are commonly used by women during their childbearing years.”

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