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Expert Opin Drug Saf. 2012 May;11(3):425-37. doi: 10.1517/14740338.2012.670419. Epub 2012 Mar 9.

Lithium in pregnancy: the need to treat, the duty to ensure safety.

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Department of Mental Health ASL Salerno, Mental Health Center, Salerno, Italy.



Untreated bipolar disorder during pregnancy leads to detrimental repercussions on the mother-infant pair's health. Despite different drugs having been proposed as mood stabilizers, lithium remains the first-choice agent for preventing mood changes.


Analyzing up-to-date information on the reproductive safety of lithium and providing practice guidelines to optimize its use during pregnancy.


Findings from prospective and case-control studies confirm an increased, specific risk of Ebstein's anomaly (4.45-7.6/1000 live births), although lower than that previously reported. A potential increase in the risk of neural tube defects should also be taken into consideration. Moreover, several perinatal complications may occur, and even in the presence of relatively low infant serum levels, in the case of drug exposure during late pregnancy. Despite such concerns, lithium should still be considered the first-choice agent for treating bipolar disorder in pregnancy. Indeed, the U.S. FDA recently issued a new warning regarding the reproductive safety of antipsychotics. Moreover, the risk of fetal valproate/carbamazepine syndrome (and the confirmed neurodevelopmental teratogenicity of valproate) contraindicates the use of both medications, whereas the use of lamotrigine is limited by efficacy concerns. However, women who need lithium treatment during pregnancy should be carefully monitored: a strict gynecologic and psychiatric surveillance and, probably, preconception folate supplementation is highly advisable. Moreover, delivery should be programmed in Neonatal Intensive Care Units to ensure optimal management of potential iatrogenic perinatal complications.

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