Topiramate use in pregnancy: MHRA safety guidelines tightened

Topiramate should not be prescribed to women of childbearing potential without a pregnancy prevention plan, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced.

The MHRA updated its safety guidelines for the use of the medicine topiramate (brand names Topamax and Topiragen) on 20 June 2024. Topiramate is used to treat epilepsy and migraines.

Previous MHRA guidelines from May 2022 said that before being prescribed topiramate, women should be fully informed of the risks during pregnancy, and in epilepsy, alternative options should be considered first.

The new guidelines state that topiramate should not be given to “women of childbearing potential unless the conditions of a Pregnancy Prevention Programme are fulfilled”.

They continue to stress that women must be made aware of the risks of topiramate and now need to sign the Risk Awareness Form.

The update follows a review conducted by the MHRA, which found that “the use of topiramate during pregnancy is associated with significant harm to the unborn child”.

The MHRA said the medicine could lead to birth defects and low birth weight. It said that it could also increase the risk of intellectual disability, autistic spectrum disorder (ASD) and attention deficit hyperactivity disorder (ADHD) in children.

Advice from the MHRA says that women should always use effective birth control while taking topiramate and four weeks after stopping the medicine. Topiramate can change how effective some hormonal types of birth control are, so the MHRA advises women to speak to their GPs or specialists about effective contraception.

The MHRA said women with epilepsy taking topiramate, who are thinking about having a baby or think they might be pregnant should continue to take their epilepsy medicine and make an urgent appointment with their GP or epilepsy team.

Stopping an epilepsy medicine could lead to seizures restarting or becoming more frequent or more severe.

Reduced medication options for women

The latest NHS England statistics show that in September 2023, the number of females aged under 55 years old who were prescribed topiramate was just over 30,000.

Alison Fuller, director of health improvement and influencing at Epilepsy Action, said: “Information is always key.

“From some of our previous research, we know not enough women were being fully informed about the risks some anti-seizure medications pose to pregnancy. The inclusion of topiramate in the Pregnancy Prevention Programme should at least ensure that these conversations are happening.

“Clinicians need the right support to make sure that the change in rules is effectively communicated to affected patients, and that they can make informed decisions about their care.

“While these new rules coming into effect may be concerning for some people, it’s important no one stops taking medication without speaking to their specialist.

“We understand that these new measures could potentially reduce medication options for women of child-bearing age. Also, we know that neurology staffing levels are extremely low in the UK, and new referrals could increase the already critical waiting times.

“We will monitor the roll-out closely and keep sharing any new information with our supporters as any developments occur.”

“No information and no idea”

Epilepsy Action, Young Epilepsy and Epilepsy Society surveyed more than 1,200 women and girls with epilepsy in 2022 about epilepsy medicines in pregnancy. The survey showed that more than a quarter of respondents taking topiramate (28%) didn’t know about the risks of the medicine in pregnancy.

One responder taking topiramate said: “I had no idea any of these medications could be harmful.”

Another commented: “When I was first diagnosed, I was 20. I had no information and no idea about epilepsy and pregnancy. I think part of the reason I haven’t had children is because I was afraid of the effects of my tablets on a baby.”

Some responders had already been through pregnancy. One said: “It was mentioned when I was first diagnosed that some medications wouldn’t be suitable if I wanted a child, but my neurologist didn’t tell me which ones would put my baby at risk. I was on topiramate and carbamazepine when my child was born seven years ago (I didn’t know I was pregnant until I was in labour) and I had to be checked over. Luckily my child is okay, however, he’s on the waiting list to be screened for autism and ADHD.”

Another responder shared her experience, saying: “I’ve successfully had two safe pregnancies and healthy children with advice from my neurologist and epilepsy nurse.”

The MHRA is urging anyone taking topiramate to use the Yellow Card Scheme to report any side effects of their treatment.