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The summary of product characteristics (SmPC) for the antiepileptic medicine Keppra (levetiracetam; UCB Pharma) has been updated to include clinical trials that did not suggest an increased risk of autism or intellectual disability in children whose mothers had used the medicine during pregnancy.
The update to the SmPC for Keppra, added on 4 December 2025 and published on 15 December 2025, refers to two observational studies, which analysed data from more than 1,000 children born to women with epilepsy who were exposed to levetiracetam monotherapy during the mother’s pregnancy.
“The two studies do not suggest an increased risk of autism spectrum disorders or intellectual disability compared to children born to women with epilepsy not exposed to an antiepileptic drug in utero,” the updated SmPC says.
“Levetiracetam can be used during pregnancy, if after careful assessment it is considered clinically needed — in such case, the lowest effective dose is recommended.”
Keppra is an anticonvulsant monotherapy for partial onset seizures in adults and adolescents aged 16 years and over with newly diagnosed epilepsy.
The SmPC adds: “Limited evidence is available on the neurodevelopment of children exposed to levetiracetam monotherapy in utero.”
The results of an earlier study, published in JAMA Neurology in April 2023, demonstrated a link between prenatal use of levetiracetam development of attention deficit hyperactivity disorder and anxiety in childhood. However, these findings were in contrast to previous research, which suggested that children exposed to levetiracetam had similar risks for neurodevelopmental disorders as unexposed children.
Alison Fuller, director for health improvement and influencing at Epilepsy Action, said: “The updated information on levetiracetam offers some reassurance for women with epilepsy who are pregnant or planning a pregnancy.
“The studies referenced do not suggest an increased risk of autism spectrum disorders or intellectual disability compared with children born to women with epilepsy who were not taking the medicine, which is encouraging.
“However, it is important to be clear that the available evidence on longer-term neurodevelopmental outcomes is still limited and decisions during pregnancy need to carefully balance any potential risks against the significant risks of uncontrolled seizures for both mother and baby.”
“We would strongly advise women not to stop or change their epilepsy medication without medical advice,” she added.
