Epilepsy Home > Keppra XR and Pregnancy

In animal studies on Keppra XR (levetiracetam XR) and pregnancy, the drug increased the risk of miscarriage, low fetal weight, and birth defects when it was given to pregnant rabbits. It also increased the risk of minor behavioral problems and death in newborn rats. Due to these potential complications, notify your healthcare provider if you are taking Keppra XR and pregnancy occurs.

Is Keppra XR Safe During Pregnancy?

Keppra XR™ (levetiracetam XR) may not be safe for use during pregnancy, although the full risks are not currently known. In animal studies that evaluated the effects of Keppra XR use during pregnancy, the drug caused various problems.

Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medications that have not been studied in pregnant humans but that appear to cause harm to the fetus in animal studies. Also, medications that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Keppra XR was assigned a pregnancy Category C rating due to problems seen in animal studies. When given to pregnant rabbits, it increased the risk of miscarriage, low fetal weight, and birth defects. When given to pregnant rats, levetiracetam (the active ingredient in Keppra XR) increased the risk of minor skeletal problems and slow growth (both before birth and after). At very high doses, levetiracetam also increased the risk of behavior problems and death in the newborn rats.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the pregnant woman outweigh any possible risks to the unborn child. Keppra XR may not be the best choice for pregnant women with epilepsy, as it is intended to be used only in combination with other seizure medications. It is generally accepted that taking a single seizure medication (rather than two or more) is best for pregnant women.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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