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Lithium and Pregnancy

In studies involving lithium and pregnancy, the drug increased the risk of birth defects, especially heart defects. As a result, the FDA has classified it as a pregnancy Category D medication, meaning it is generally considered unsafe for use during pregnancy. However, if you are taking lithium and pregnancy occurs, your healthcare provider may have you continue taking it if the benefits outweigh the risks.

Is Lithium Safe During Pregnancy?

Lithium (Eskalith®, Eskalith CR®, Lithobid®) is a prescription medication approved for treating bipolar disorder. It is generally considered unsafe for pregnant women to take the drug. In human and animal studies, lithium increased the chance of problems for the fetus, including birth defects.

Lithium and Pregnancy Category D

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category D is a classification given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but may still offer benefits that outweigh the risks the drug presents. Therefore, a pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the risks to the unborn child.
Lithium was given a pregnancy Category D classification because of the problems that occurred during human and animal studies. Lithium appears to increase the risk of birth defects, especially heart defects. The risk is higher if lithium is taken during the first trimester of pregnancy.

Suggestions for Lithium and Pregnancy

If you are taking lithium and pregnancy occurs (or if you are thinking of becoming pregnant while taking the drug), let your healthcare provider know. He or she will consider both the benefits and risks of using lithium during pregnancy before making a recommendation in your particular situation.
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