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Safety review of epilepsy medicines in pregnancy published

On Friday, the Medicines and Healthcare products Regulatory Agency (MHRA) published a review of the risks associated with commonly prescribed antiepileptic medication during pregnancy.

Why was the review published?

The safety of epilepsy medicines in pregnancy came into question when the antiepileptic drug sodium valproate was found to have harmful effects on foetal development. Research funded by Epilepsy Research UK was one of several important initial studies that led to the understanding that taking sodium valproate during pregnancy carries a 4 in 10 risk of developmental disorders and roughly a 1 in 10 risk of birth defects for the baby.

The MHRA review was carried out following these earlier reviews of Valproate to investigate if other key antiepileptic drugs carry similar risks in pregnancy. The review has been published alongside a patient leaflet to aid discussions with clinicians and patients on potential risks associated with antiepileptic medication and to help inform and review patient treatments.

What were the findings?

The review urges women who are receiving treatment for epilepsy to discuss the right treatment for them with a healthcare professional if they anticipate becoming pregnant, even sometime in the future.

The review found that lamaotrigine (Lamictal) and levetiracetam (Keppra) did not carry an increased risk in pregnancy. Four medicines were found to increase the risk of a baby being born with a physical birth defect if taken during pregnancy: carbamazepine (Tegretol), phenobarbital, phenytoin (Epanutin) and topiramate (Topamax). A further 14 medicines were included in the review, but more data is needed to form a conclusion about their safety when used during pregnancy.

The importance of the review and research into understanding antiepileptic drugs in pregnancy

Epilepsy Research UK SAC Member Dr Rebecca Bromley is an expert in this field of research, having contributed to guidance on prescription medicine for women with epilepsy, after receiving early career support from Epilepsy Research UK.

Dr Bromley said: “The experience with valproate led to changes beyond medications used to treat epilepsy. The ‘First Do No Harm’ Review, published in July 2020, responded to patient concerns about side effects from NHS treatments including sodium valproate. The review concluded that wider change is required to optimise maternal and foetal health in pregnancy, including research into other antiepileptic drugs.”

Epilepsy Research UK supporter and blogger Faye Waddams said:

“Women welcome the fact that antiepileptic drugs are being reviewed. Pregnancy is already such an anxious time for women with epilepsy and knowing that lamotrigine (Lamictal) and levetiracetam (Keppra) pose no increased risk will reassure women that there are options available. I wish this kind of review had been available when I was looking to have a family. The most important things are that women are given a choice, that those choices are discussed with their neurology teams and that women never just stop taking medication without medical advice.”

Despite the findings of this review, it is important that women do not stop taking antiepileptic medication without seeking advice from a clinician. The MHRA advises women to discuss their epilepsy treatment with a healthcare professional.

Find out more about Epilepsy Research UK’s funded research in this area here.

Read Dr Rebecca Bromley’s Research Blog on the First Do No Harm Review here.

Read more about the release of the Cumberlege (First Do No Harm) Review here.

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