UK regulator to consider EMA recommendation to avoid topiramate in pregnancy

Exclusive: The UK medicines regulator said it would carefully consider recommendations made by the European Medicines Agency, which were published following a review of data showing an increased risk of developmental disorders among children exposed to topiramate before birth.
Pregnant woman taking tablet

The Medicines and Healthcare products Regulatory Agency (MHRA) has said it will consider recommendations made by the European Medicines Agency (EMA) as part of its ongoing safety review into the use of topiramate during pregnancy.

In September 2023, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended new measures to avoid children’s exposure to topiramate-containing medicines in the womb.

In the announcement, PRAC said that its recommendations followed a review of available data, including an observational study published in JAMA Neurology in May 2022. Results of the study showed there was a two- to four-fold increased risk of developmental disorders, such as autism spectrum disorder or learning difficulties, among children exposed to topiramate before birth.

The researchers, who studied records of 4.5 million children in Denmark, Finland, Iceland, Norway and Sweden, concluded: “Our results do not suggest that topiramate is a safe alternative to valproate.” They also found that sodium valproate was linked to a similar level of risk as topiramate.

As a result, PRAC advised that topiramate-containing medicines “must not be used to prevent migraine or manage bodyweight during pregnancy” and recommended that they should only be used during pregnancy if there is “no other suitable treatment for epilepsy available”.

The EU regulator also recommended additional measures such as a ‘pregnancy prevention programme’ to inform any women of child-bearing age on the risks of taking topiramate during pregnancy and the need to avoid becoming pregnant while taking the medication.

The observational study published in May 2022 also prompted the MHRA to launch a safety review of topiramate in July 2022, alongside a drug safety update notice.

According to the latest data published by NHS England on 28 September 2023, some 394 women were prescribed topiramate during pregnancy between April 2022 and March 2023 — a slight decrease on the 430 pregnant women who were prescribed topiramate between April 2021 and March 2022.

Responding to the EMA recommendations, the MHRA said in a statement that it is aware of the recommendations made by PRAC and is considering them carefully.

Alison Cave, chief safety officer at the MHRA, said: “Healthcare professionals who prescribe topiramate should follow the advice in the product information.

“This already states that topiramate should not be used during pregnancy for migraine prophylaxis, and that anyone who is able to get pregnant should have a pregnancy test before starting topiramate and should use an effective method of contraception while taking it.

“Individuals should not stop taking topiramate without advice from their doctor,” she added.

The MHRA is yet to announce when its safety review will conclude.

Last updated
The Pharmaceutical Journal, PJ, October 2023, Vol 311, No 7978;311(7978)::DOI:10.1211/PJ.2023.1.199178

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