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Maternal quetiapine exposure may not contribute to malformations in infants

Study results published in the American Journal of Psychiatry indicated that quetiapine exposure during first-trimester pregnancy was not strongly associated with major malformation in infants.

However, the authors cautioned that these results can only rule out an approximate fivefold increased risk for malformation due to the uncertainty over the exact risk estimate.

“The ability to delineate risk of malformations associated with particular second-generation antipsychotics has been limited,” Lee S. Cohen, MD, department of psychiatry and the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital, and colleagues wrote. “The existing data on malformations associated with quetiapine exposure is derived mainly from a small number of studies with differing methodologies and outcome measures.”

Researchers examined the risk for major malformations among infants exposed to quetiapine during the first trimester of pregnancy compared with infants born to mothers with a history of psychiatric morbidity who did not use a second-generation antipsychotic during pregnancy using data from National Pregnancy Registry for Atypical Antipsychotics interviews. They screened obstetric, labor and delivery records, and pediatric medical records from the first 6 months of life for evidence of major malformations, then sent the records to a dysmorphologist for final blind adjudication.

Of 357 participants eligible for analysis, 152 women with first-trimester quetiapine exposure were compared with 205 control subjects without second-generation antipsychotic exposure. In the exposed group, 126 women used quetiapine during the entire gestational period and 152 used quetiapine during the first trimester.

The prevalence of major malformations among 155 infants with first-trimester exposure to quetiapine was 1.29% (95% CI, 0.16-4.58). The prevalence was 1.43% among 210 infants unexposed to second-generation antipsychotics (95% CI, 0.3-4.12). Researchers confirmed two major malformations in the exposed group (1.3%) compared with three in the unexposed group (1.4%). For babies with first-trimester exposure, the unadjusted OR was 0.9 (95% CI, 0.15-5.46) compared with babies without exposure.

“The data from this analysis are consistent with the existing literature, which does not suggest a strong association between fetal exposure to second-generation antipsychotics and an increase in the rates of major malformations,” 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.” – by Savannah Demko

Disclosure s : Cohen reports National Pregnancy Registry for Atypical Antipsychotics research support from Alkermes, Forest/Actavis, Otsuka, Sunovion, and Teva. He also reports support from the Brain and Behavior Research Foundation, JayMac Pharmaceuticals, the National Institute on Aging, NIH, NIMH, SAGE Therapeutics and Takeda/Lundbeck Pharmaceuticals; and serving as a consultant or adviser for Alkermes and JDS Therapeutics. Please see the study for all other authors’ relevant financial disclosures.