Data on Second-Generation Antipsychotics During Pregnancy ‘May be Reassuring’

A new study gauges the absolute risk of major birth defects among infants exposed to second-generation antipsychotics during the first trimester of pregnancy to be 1.4%, compared with 1.1% for infants unexposed to the drugs. Researchers reported their findings in the online American Journal of Psychiatry. 

“The results suggest that it would be unlikely for second-generation antipsychotics to raise the risk of major malformations more than 10-fold beyond that observed in the general population or among control groups using other psychotropic medications,” the researchers concluded. 

The results are based on data from the National Pregnancy Registry for Atypical Antipsychotics, based at the Center for Women’s Mental Health at Massachusetts General Hospital, Boston. For the study, researchers looked at pregnancy and postpartum medical records for 214 live births with first-trimester exposure to second-generation antipsychotics and compared them with 89 live births of unexposed infants of mothers with histories of psychiatric conditions. 

Among infants exposed to the antipsychotics, researchers found three major malformations. One major malformation was confirmed among infants unexposed to antipsychotics. Researchers calculated the odds ratio for major malformations of exposed infants compared to unexposed infants was 1.25. 

“If the estimate stabilizes around the null with ongoing data collection,” they wrote, “findings may be reassuring for both clinicians and women trying to make risk-benefit treatment decisions about using atypical antipsychotics during pregnancy.” 

—Jolynn Tumolo 

Reference 

1. Cohen LS, Viguera AC, McInerney KA, et al. Reproductive safety of second-generation antipsychotics: current data from the Massachusetts General Hospital National Pregnancy Registry for Atypical Antipsychotics. The American Journal of Psychiatry. 2015 Oct. 6. [Epub ahead of print].