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New safety review into topiramate (Topamax)

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Nicola Swanbrough

New safety review into topiramate (Topamax)

A new safety review is being launched into the epilepsy medication topiramate. The drug (brand name Topamax) is already known to be associated with an increased risk of congenital malformations and effects on fetal growth when taken during pregnancy. 

But a new study has pointed to an increased risk of neurodevelopmental disabilities including autism spectrum disorder and effects on learning and development in children exposed to the drug in the womb. 

Women who are taking topiramate should be advised by their doctor to take an effective form of birth control and to avoid becoming pregnant. Any woman with epilepsy who is planning a pregnancy should talk to her doctor urgently about safer treatment options. 

But it is also important not to stop taking the medication without the supervision of a healthcare professional.

The study is being launched by the regulatory agency responsible for the safety of medicines – the MHRA – which will assess all relevant data.

Low birth weight and size

A previous review in January 2021 by the Commission on Human Medicines into the safety of anti-seizure medicines during pregnancy, showed that topiramate was linked to an increased risk of birth defects and an increased risk of a baby being born with a low birth weight and small for gestational age (fetal growth restriction).

The review found that the two epilepsy medications lamotrigine and levetiracetam, were safer to take during pregnancy, while many other epilepsy drugs also posed a risk.

The MHRA review will examine the risks and benefits of topiramate and assess whether any regulatory action needs to be taken to minimise risk and increase awareness. It will also consider what future research could be undertaken into the long-term impact on children exposed to topiramate during pregnancy.

Safe Mum Safe Baby

Nicola Swanborough, Head of External Affairs at the Epilepsy Society, said: “This is an important review and it is essential to look at the long-term impact of topiramate on children exposed to the drug. But it also highlights the urgent need for vital research into all anti-seizure medications during pregnancy.

“Many women are forced to make unimaginable choices between taking a drug that will control their seizures during pregnancy but that may pose a risk to their baby; or taking a drug that will not give them such good seizure control but that will be safer for their baby.

“Our scientists know that genomic research could help to identify which pregnancies may be vulnerable to which medications. With the right investment in research, they could take the lottery out of pregnancy for women with epilepsy. And the only thing that is holding them back is money.

“The Government has launched its Women’s Health Strategy with an emphasis on reproductive and gynaecological issues. It has promised to listen to women. And women with epilepsy are telling them that pregnancy can be a scary time. It shouldn’t and needn’t be.

“We have already seen the devastating effects that the epilepsy drug, valproate, has had on thousands of families across the UK.  The government must ensure that forward thinking research is allowed to stop history to repeat itself.”

Call our Helpline

If you have any concerns around your epilepsy medication and would like to talk to someone, please call our Epilepsy Helpline on 01494 601400 (Mon-Fri 9am-4pm, Wed 9am-7.30pm).