Press Release - Jun 19, 2014New Research Does Not Find a Direct Link between Antidepressant Use in Pregnancy and Heart Malformations in Infants
Clinical depression is diagnosed in 10-15 percent of pregnant women in the United States and increasingly those women are being prescribed antidepressant medications. In 2005, the FDA issued a warning indicating that based on early research results, exposure to commonly prescribed antidepressants may increase the risk of malformations of the heart in the developing fetus. In new research from Brigham and Women's Hospital (BWH) and Harvard School of Public Health (HSPH), researchers report no substantial increase in the risk of heart malformations attributable to the most commonly prescribed antidepressants in pregnancy.
This research is published in the June 19, 2014 issue of the New England Journal of Medicine.
"While several studies have evaluated the impact of prenatal exposure to selective serotonin reuptake inhibitors (SSRIs), the most commonly prescribed antidepressants during pregnancy, there remained significant confusion and controversy about whether these medications increased the risk of congenital cardiac malformations," said Krista F. Huybrechts, Ph.D, lead author of the study and a researcher in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women's Hospital. "Clinicians should be reassured that if women need SSRIs during pregnancy, we have not observed a substantially increased risk of having a child with cardiac malformations."
In this large observational study, researchers analyzed data from 949,504 pregnant women across the United States who were enrolled in Medicaid from three months before conception through one month post delivery, and their live-born infants. Researchers found that 6.8 percent of women used antidepressants during the first trimester, and report that 72.3 per 10,000 infants not exposed to antidepressants were born with a cardiac defect, compared with 90.1 per 10,000 infants who were exposed to the medications. After controlling for depression severity and other potential risk factors, there was no association between use of the most common types of antidepressants and heart malformations in the infants. Moreover, there was no association between paroxetine and right ventricular outflow tract obstruction, and between sertraline and ventricular septal defects; two potential associations that had been of particular concern based on previous research findings.
"It is important to recognize that this is only one piece of the complex puzzle about the safety of antidepressants during pregnancy," said senior author Sonia Hernández-Díaz, MD DrPH, from the Harvard School of Public Health. "More research is necessary to evaluate the risks and benefits of using these medications during pregnancy for both women and their newborns."
This study was supported by AHRQ Award R01 HSO18533. Krista Huybrechts was supported by a career development grant K01MH099141 from the National Institute of Mental Health. Kristin Palmsten was supported by Training Grant T32HD060454 in Reproductive, Perinatal and Pediatric Epidemiology from the National Institute of Child Health and Human Development, National Institutes of Health.
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