Review initiated into topiramate over dangers to unborn children


A review into the safety of topiramate has been launched by the Medicines and Healthcare products Regulatory Agency (MHRA) after study results had shown a more significant risk of developmental disorders, learning difficulties and autism among babies exposed to topiramate during their mother’s pregnancy.

The review will determine whether additional measures are needed to reduce the danger of harm from topiramate, which is used for treating epilepsy and migraines during pregnancy. In addition, according to study results, topiramate has already been linked to effects on prenatal growth and congenital malformations.

“The new review was triggered by an observational study which showed an increased risk of developmental difficulties among children exposed to topiramate.“

The new review was triggered by an observational study published in May 2022, which showed a two to four-fold increased risk of learning difficulties or developmental disorders among children exposed to topiramate before birth.

The records of four-and-a-half million children in Sweden, Finland, Norway, Iceland and Denmark were studied by researchers who concluded: “Our results do not suggest that topiramate is a safe alternative to valproate.”

In January 2021, as part of a review of all antiepileptic drugs, the safety of topiramate was assessed by the Commission on Human Medicines.

Despite the MHRA already advising against the use of valproate for women of childbearing age, NHS Digital data has revealed that, between October 2020 and September 2021, nearly fifty pregnant women were prescribed the drug in England.

In addition, the MHRA has recently asked the Commission on Human Medicines to examine whether the genetic changes caused by the antiepileptic drug can be passed down through generations.

Encouraging the evaluation into topiramate, a spokesperson for Epilepsy Action, a charity, stated, “It is crucial that women do not stop taking their epilepsy medicines without talking to their doctor first. Anyone taking topiramate who is pregnant or planning a pregnancy should contact their epilepsy specialist nurse or doctor for urgent advice about the safest medicine for them and their baby.”

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