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Keppra and women with epilepsy

Keppra (all doses) is associated with a lower risk of MCM, compared with older AEDs such as valproate and carbamazepine (>700 mg/day) in infants exposed in utero1,2

Comparative risk of MCM in fetuses exposed to different AEDs in utero: data from EURAP registry 1

A longitudinal, prospective cohort study based on the International Registry of Antiepileptic Drugs and Pregnancy (EURAP) from 42 countries. Data collected from 7,555 prospective pregnancies during June 1999 to May 2016. The risk of major congenital malformations was assessed at 1 year after birth in offspring exposed prenatally.1


The same results were first published in Tomson T, et al. Lancet Neurol 2018;17(6):530–538. The graph has been independently created by GSK from the original data.

Comparative risk of MCM in fetuses exposed to different AEDs in utero: data from North American Pregnancy Registry (NAAPR)2

A telephone survey to evaluate the effects of epilepsy and anti-epileptic drugs used during pregnancy on fetal growth and preterm delivery of singleton liveborn infants born to women enrolled in the North American Antiepileptic Drug Pregnancy Registry between 1997 and 2016.2

The same results were first published in Hernandez-Diaz S, et al. Neurology 2012;78(21): 1692–1699. The graph has been independently created by GSK from the original data.

Safety information: Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy which is more pronounced in the third trimester.3

*Note that 4000 mg/day is above the approved dose for levetiracetam in epilepsy.

Keppra in women with epilepsy

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Safety information: In WWE, specialist advice should be given to those of childbearing potential. Sudden discontinuation of levetiracetam should be avoided, as it can lead to breakthrough seizures. No impact on fertility was detected with levetiracetam in animal studies. No clinical data are available, potential risk for human is unknown. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended.3

*Only limited evidence is currently available on the neurodevelopment of children exposed to Keppra monotherapy in utero.3

Read more about Keppra


AED: anti-epileptic drug; CBZ: carbamazepine; CNP: clonazepam; EURAP: International Registry of Anti-Epileptic Drugs and Pregnancy; LEV: levetiracetam; LTG: lamotrigine; MCM: major congenital malformations; NAAPR: North American AED Pregnancy Registry; OXC: oxcarbazepine; PB: phenobarbital; PHT: phenytoin; SD: study design; TPM: topiramate; VPA: valproate; WWE: women with epilepsy.


  1. Tomson T, et al. Lancet Neurol 2018;17(6):530–538.
  2. Hernandez-Diaz S, et al. Neurology 2012;78(21):1692–1699.
  3. Levetiracetam. Non Central Data Sheet Version Number: 10. Version Date: 6 January, 2020.

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Keppra is a registered trademark of the GlaxoSmithKline group of companies

PM-NG-LVT-WCNT-200004 Date of preparation: November 2020.