Public Release: 

Antipsychotic medication poses little risk to developing fetus

New research from Brigham and Women's Hospital finds use of antipsychotic medication during early pregnancy does not meaningfully increase the risk of congenital malformations

Brigham and Women's Hospital

BOSTON, MA - Exposure to antipsychotic medications (APMs) during pregnancy is increasingly common. Widespread use of newer "atypical" drugs which are less likely to affect fertility than the older "typical" antipsychotics, combined with the deinstitutionalization of psychiatric patients, is attributed to doubling the use of antipsychotics during pregnancy in the past decade, yet, clinicians have little information regarding the safety of these drugs for the developing fetus and concerns have been raised about a potential association with congenital malformations.

In a new study at Brigham and Women's Hospital published in JAMA Psychiatry on August 17, 2016, researchers examined the risk of congenital malformations overall, and cardiac malformations in particular, in association with first trimester exposure to different APMs in a large population-based cohort study. Researchers found that the use of APMs in pregnancy does not meaningfully increase the risk of congenital malformations or cardiac malformations, with the possible exception of risperidone.

"Our findings help inform psychiatrists and their patients about the risk of using APMs during early pregnancy," stated Krista F.G. Huybrechts, MS, PhD, associate epidemiologist in the Division of Pharmacoepidemiology and Pharmacoeconomics at BWH. "In general, the use of any medication should be avoided during pregnancy. However, for women suffering from schizophrenia, bipolar disorder, or major depressive disorder, avoiding medication use is often impossible, given that there are very few alternative treatment options."

Huybrechts and her colleagues analyzed data from a nationwide sample of 1,341,715 pregnant women enrolled in Medicaid from three months before their last menstrual period through at least one month after delivery. Exposure to APMs was determined based on documentation which indicated that at least one prescription for APMs was filled during the first 90 days of pregnancy. Typical and atypical APMs were evaluated as two separate classes, as well as the most frequently used individual medications: aripiprazole, olanzapine, quetiapine, risperidone and ziprasidone.

Among the women studied, 9, 258 women (0.69 percent) filled a prescription for an atypical APM, and 733 women (0.05 percent) filed a prescription for a typical APM. Researchers found that 4.45 percent of births exposed to atypical APMs and 3.82 percent of births exposed to typical APMs were associated with congenital malformations. Among women who did not fill a prescription for an APM, 3.27 percent of births were diagnosed with congenital malformations. The findings for cardiac malformations were similar.

After controlling for other possible contributing mental and physical conditions and their associated behaviors, researchers found no significant increased risk for either congenital malformations or cardiac malformations among women who took either typical or atypical APMs in the first 90 days of pregnancy, with the possible exception of risperidone which continued to show a slightly increased risk.

"Further research is needed to assess whether the increased risk for risperidone reflects a true casual association or a chance finding," Huybrechts said.


This study was supported by grants R01MH100216 and K01MH099141 from the National Institute of Mental Health, grant K08HD075831 from the National Institute of Child health and Human Development and a Swiss National Science Foundation grant P3SMP3-158808/1.

Brigham and Women's Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. BWH has more than 4.2 million annual patient visits and nearly 46,000 inpatient stays, is the largest birthing center in Massachusetts and employs nearly 16,000 people. The Brigham's medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in patient care, quality improvement and patient safety initiatives, and its dedication to research, innovation, community engagement and educating and training the next generation of health care professionals. Through investigation and discovery conducted at its Brigham Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 3,000 researchers, including physician-investigators and renowned biomedical scientists and faculty supported by nearly $666 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals. BWH is also home to major landmark epidemiologic population studies, including the Nurses' and Physicians' Health Studies and the Women's Health Initiative as well as the TIMI Study Group, one of the premier cardiovascular clinical trials groups. For more information, resources and to follow us on social media, please visit BWH's online newsroom.

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