(New York - June 18, 2018) -- Researchers from the Icahn School of Medicine at Mount Sinai found an elevated risk of major congenital malformations in fetuses after first-trimester exposure to lithium, in the largest study ever to examine the risk of birth defects in lithium-exposed babies.

Nearly one and one-half times as many babies exposed to lithium during the first trimester experienced major malformations compared to the unexposed group (7.4 percent compared with 4.3 percent). In addition, risk for neonatal hospital readmission was nearly doubled in lithium-exposed babies compared to the unexposed group (27.5 percent versus 14.3 percent). However, lithium exposure was not associated with pregnancy complications or other delivery outcomes, such as pre-eclampsia, preterm birth, gestational diabetes, or low birth weight. In addition, the researchers found that the risk of birth defects in lithium-exposed infants was lower than previously thought, because previous studies did not look at large enough populations.

The study will be published online on Monday, June 18, at 6:30 pm EDT, in The Lancet Psychiatry.

The study examined the risk of congenital malformations such as heart defects and pregnancy complications in a meta-analysis of primary data from 727 lithium-exposed pregnancies compared to a control group of 21,397 pregnancies in mothers with a mood disorder who were not taking lithium. The data was taken from six study sites in Denmark, Canada, the Netherlands, Sweden, the United Kingdom, and the United States. The researchers also measured delivery outcomes and neonatal hospital readmissions within 28 days of birth.

Lithium therapy is widely recommended as a first-line treatment for bipolar disorder, which affects approximately 2 percent of the world's population. Lithium helps to prevent severe depression and mania. In the United States, bipolar disorder is more commonly treated with anti-psychotic drugs instead of lithium. "Women should be informed on malformation risk in first-trimester exposed infants, but also about very high relapse risks for mental illness both during pregnancy and during the postpartum period," said the study's senior author, Veerle Bergink, MD, PhD, Professor of Psychiatry and of Obstetrics, Gynecology, and Reproductive Science, Icahn School of Medicine at Mount Sinai. "Given the well-documented effectiveness of lithium in reducing relapse in the perinatal period, some important clinical considerations are either to continue lithium in a lower dose during the first trimester or to restart lithium after the first trimester or immediately postpartum."

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Other institutions involved in this study include Aarhus University in Denmark; Lundbeck Foundation Initiative for Integrative Psychiatric Research, in Denmark; Karolinska Institutet, in Sweden; University of Toronto, Scarborough, in Canada; Women's College Hospital in Toronto, Canada; University of Toronto in Canada; Institute for Clinical Evaluative Sciences in Toronto, Canada; Cardiff University in the United Kingdom; University of North Carolina at Chapel Hill School of Medicine; Indiana University; King's College London in the United Kingdom; Leiden University Medical Center in the Netherlands; and Erasmus Medical Centre in The Netherlands.

This study was supported by grants from the National Institutes of Mental Health.

About the Mount Sinai Health System

The Mount Sinai Health System is New York City's largest integrated delivery system encompassing seven hospital campuses, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region. Mount Sinai's vision is to produce the safest care, the highest quality, the highest satisfaction, the best access and the best value of any health system in the nation. The System includes approximately 7,100 primary and specialty care physicians; 10 joint-venture ambulatory surgery centers; more than 140 ambulatory practices throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and 31 affiliated community health centers. The Icahn School of Medicine is one of three medical schools that have earned distinction by multiple indicators: ranked in the top 20 by U.S. News & World Report's "Best Medical Schools", aligned with a U.S. News & World Report's "Honor Roll" Hospital, No. 13 in the nation for National Institutes of Health funding, and among the top 10 most innovative research institutions as ranked by the journal Nature in its Nature Innovation Index. This reflects a special level of excellence in education, clinical practice, and research. The Mount Sinai Hospital is ranked No. 18 on U.S. News & World Report's "Honor Roll" of top U.S. hospitals; it is one of the nation's top 20 hospitals in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Geriatrics, Nephrology, and Neurology/Neurosurgery, and in the top 50 in four other specialties in the 2017-2018 "Best Hospitals" issue. Mount Sinai's Kravis Children's Hospital also is ranked in six out of ten pediatric specialties by U.S. News & World Report. The New York Eye and Ear Infirmary of Mount Sinai is ranked 12th nationally for Ophthalmology and 50th for Ear, Nose, and Throat, while Mount Sinai Beth Israel, Mount Sinai St. Luke's and Mount Sinai West are ranked regionally. For more information, visit http://www. mountsinai. org/ , or find Mount Sinai on Facebook, Twitter and YouTube.