• Press Release

Mount Sinai Researchers Find Increased Risk of Birth Defects in Babies After First-Trimester Exposure to Lithium

However, absolute risk is less than previously thought

  • New York, NY
  • (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 was published online 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.”

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

Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 43,000 employees working across eight hospitals, over 400 outpatient practices, nearly 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time — discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it.

Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment. The Health System includes approximately 7,300 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News & World Report’s “Best Children’s Hospitals” ranks Mount Sinai Kravis Children's Hospital among the country’s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is one of three medical schools that have earned distinction by multiple indicators: It is consistently ranked in the top 20 by U.S. News & World Report's "Best Medical Schools," aligned with a U.S. News & World Report "Honor Roll" Hospital, and top 20 in the nation for National Institutes of Health funding and top 5 in the nation for numerous basic and clinical research areas. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

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