Most Antipsychotics Found To Not Raise Risk of Congenital Malformations Interview with:

Krista F. Huybrechts, M.S., Ph.D. Assistant Professor of Medicine at Harvard Medical School Epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women’s Hospital. Boston, MA 02120

Dr. Krista Huybrechts

Krista F. Huybrechts, M.S., Ph.D.
Assistant Professor of Medicine
Harvard Medical School
Division of Pharmacoepidemiology and Pharmacoeconomics
Brigham and Women’s Hospital
Boston, MA 02120 What is the background for this study?

Response: The use of antipsychotic medications during pregnancy has doubled in the last decade. Yet, information on the safety of antipsychotic medication use during pregnancy for the developing fetus is very limited: existing studies tend to be small (the largest study available to date includes 570 exposed women) and findings have been inconsistent. Concerns have been raised about a potential association with congenital malformations.

The objective of our study was to examine the risk of congenital malformations overall, as well as cardiac malformations given findings from earlier studies, in a large cohort of pregnant women. We used a nationwide sample of 1.3 mln pregnant women insured through Medicaid between 2000-2010, of which 9,258 used an atypical antipsychotic and 733 used a typical antipsychotic during the first trimester, the etiologically relevant period for organogenesis. We also examined the risks associated with the most commonly used individual medications. What are the main findings?

Response: Although the unadjusted risks were higher among the treated than among the untreated women, after accounting for differences in psychiatric conditions, physical co-morbid conditions and their associated behaviors, no increased risk for congenital malformations was found for atypical (RR=1.05, 95% CI 0.96-1.16) or typical (RR=0.90, 95% CI 0.62-1.31) antipsychotics. Findings were similar for cardiac malformations. For the individual agents examined, a small increased risk in overall malformations (RR=1.26, 95% CI 1.02-1.56) and cardiac malformations (RR=1.26, 95% CI 0.88-1.81) was found for risperidone that was independent of measured confounders. What should readers take away from your report?

Response: Our findings suggest that use of antipsychotics early in pregnancy does not meaningfully increase the risk for congenital malformations overall or cardiac malformations, with the possible exception of risperidone. This is important information for psychiatrists, and for pregnant women and women of reproductive age with schizophrenia, bipolar disorder, or major depressive disorder for whom avoidance of medication use during pregnancy – although desirable – is frequently not possible. What recommendations do you have for future research as a result of this study?

Response: No apparent biological mechanism can readily explain the small increase in risk observed with risperidone, and the possibility of a chance finding cannot be ruled out. It will therefore be important to examine this association in future studies that also carefully attend to the potential role of confounding, and that have adequate statistical power (our study included 1,566 women exposed to risperidone). Until such evidence is available, the findings for risperidone should be interpreted as a potential safety signal that requires further follow-up. Is there anything else you would like to add?
Response: It should be recognized that our findings are re-assuring with respect to the potential risk for congenital malformations. Our study, however, did not address the risk of other potential adverse maternal or infant outcomes, and our conclusions can therefore not be generalized to these other outcomes. Thank you for your contribution to the community.


Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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Last Updated on August 19, 2016 by Marie Benz MD FAAD