Pregnant Women with Epilepsy: New Data Eases Concerns About Autism Risk from Levetiracetam
In a move that could bring relief to many, the product information for the widely-used anti-epileptic medication Keppra (levetiracetam) has been updated to address a critical concern: its potential link to autism in children. But here's where it gets controversial—while the update suggests no increased risk of autism or intellectual disability, the debate over the safety of antiepileptic drugs during pregnancy is far from settled.
The revised summary of product characteristics (SmPC) now includes findings from two large-scale observational studies, published in December 2025, which analyzed data from over 1,000 children born to mothers with epilepsy who took levetiracetam as their sole treatment during pregnancy. These studies found no significant difference in the risk of autism spectrum disorders or intellectual disabilities compared to children whose mothers with epilepsy did not take antiepileptic medications. The SmPC states, 'Levetiracetam can be used during pregnancy if clinically necessary, with the lowest effective dose recommended.'
Keppra, primarily prescribed for partial onset seizures in adults and adolescents aged 16 and older with newly diagnosed epilepsy, has long been a go-to treatment. However, the SmPC also acknowledges, 'Limited evidence is available on the long-term neurodevelopmental outcomes of children exposed to levetiracetam in utero.' This caveat highlights the ongoing need for caution and further research.
And this is the part most people miss—earlier research, such as a 2023 study published in JAMA Neurology, suggested a potential link between prenatal levetiracetam use and an increased risk of attention deficit hyperactivity disorder (ADHD) and anxiety in children. Yet, these findings contradicted previous studies indicating that children exposed to levetiracetam faced similar neurodevelopmental risks as unexposed children. This discrepancy underscores the complexity of the issue and the importance of interpreting new data within the broader context of existing research.
Alison Fuller, director for health improvement and influencing at Epilepsy Action, commented, 'The updated information offers some reassurance for pregnant women with epilepsy or those planning pregnancy. The absence of an increased risk of autism or intellectual disability is encouraging. However, it’s crucial to remember that long-term neurodevelopmental data remains limited. Decisions during pregnancy must carefully weigh the potential risks of medication against the severe risks of uncontrolled seizures for both mother and baby.' She strongly advises women not to alter their epilepsy medication without consulting a healthcare professional.
As the conversation around antiepileptic drugs and pregnancy continues, this update provides a valuable, though not definitive, piece of the puzzle. What do you think? Does this new data ease your concerns, or do you remain cautious about the use of levetiracetam during pregnancy? Share your thoughts in the comments below and let’s keep the discussion going.
