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, 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.

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