In the United Kingdom and Ireland, it is also licensed as … A new report from the U.K. and Ireland Epilepsy and Pregnancy Registers suggests that the risk of malformations associated with levetiracetam (LVT, Keppra) use during pregnancy is low. The primary outcome was prevalence of MCMs, defined according to a modified version of the Metropolitan Atlanta Congenital Defects Program criteria. [Published online ahead of print January 9, 2013.] Benefit should outweigh risk AU TGA pregnancy category: B3 US FDA pregnancy category: C

It is recommended that the fetal growth should be monitored.

RESULTS: Of 491 women enrolled, 465 (94.7%) had a documented outcome. These prospective, observational registries were established to determine the risk of congenital malformations associated with AED use in pregnancy. …

Category 3. Dose adjustments. Levetiracetam is a pregnancy category C drug. Levetiracetam in Pregnancy: Results From the UK and Ireland Epilepsy and Pregnancy Registers.

Appropriate clinical management of pregnant women treated with levetiracetam should be ensured.

Plasma concentrations of levetiracetam have been shown to decline as pregnancy progresses and regular clinical review of women taking levetiracetam is therefore recommended.

In 6 infants, levetiracetam was undetectable (<1.7 mg/L), although one of them had a serum level of 13 … All pregnant women with epilepsy, whether taking medication or not, should be encouraged to notify the UK Epilepsy and Pregnancy Register (Tel: 0800 389 1248). Studies in female pregnant rats have shown minor fetal skeletal abnormalities when given maximum recommended human doses of levetiracetam orally throughout pregnancy and lactation.
In such case, the lowest effective dose is recommended. The dose should be monitored carefully during pregnancy and after birth, and adjustments made on a clinical basis.

This decrease is more pronounced during the third trimester (up to 60 % of baseline concentration before pregnancy). Seven breastfed infants whose mothers were taking an average dosage of 2430 mg daily (range 1500 to 3500 mg daily) of levetiracetam plus various other anticonvulsants during pregnancy and lactation had serum levetiracetam measured before the mother's morning dose at 3 to 5 days of age. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Decrease in levetiracetam plasma concentrations has been observed during pregnancy.

Women exposed to levetiracetam at any time during pregnancy enrolled, directly, or via their healthcare provider. Neurology 2013; 80 (4):400–405.


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