New pregnancy prevention measures introduced for topiramate
Migraine and antiseizure medication topiramate must no longer be prescribed to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme.
Following a major safety review triggered by a new study conducted in Europe, the MHRA is introducing new safety measures for topiramate, also known by the brand name Topamax.
The Commission on Human Medicines (CHM) looked at findings from studies examining the risks associated with the use of topiramate during pregnancy, which showed that children born to mothers who take topiramate during pregnancy face a risk level approximately 2 to 3 times higher of intellectual disability, autism spectrum disorders and attention deficit hyperactivity disorder.
Following recommendations made by the CHM, the MHRA is now advising healthcare professionals that topiramate should not be prescribed to treat epilepsy during pregnancy unless there is no suitable alternative treatment. Topiramate should already not be used during pregnancy for migraine because of the known link with an increased risk of birth defects.
In order to fulfil the conditions of a Pregnancy Prevention Programme, women of childbearing potential must use effective birth control throughout treatment and take a pregnancy test prior to starting topiramate. Healthcare professionals should make patients aware of the risks of the use of this medication during pregnancy and therefore the completion of a risk awareness form is another requirement of this programme.
Patients are also advised that some birth control methods are less effective than others when using topiramate, and their GP or sexual healthcare practitioner will be able to help advise which birth control is right for them. Regular medication reviews, at least once annually, are also recommended. New safety and educational materials have been introduced for patients and healthcare professionals to support the implementation of these measures.
Topiramate is taken to prevent migraines or for the management of epilepsy and is thought to be prescribed to just over 30,000 female patients under the age of 55 in England in one month, according to the latest data from NHS England.
Prior to the start of the review, topiramate was already known to have risks associated with significant harm during pregnancy, including a higher risk of birth defects and low birth weight. For this reason, patients were previously advised against using it during pregnancy and to use highly effective contraception during treatment. The introduction of the Pregnancy Prevention Programme will further strengthen the safety measures and aim to reduce the number of topiramate-exposed pregnancies.
Pregnant women or those planning to become pregnant, who currently take topiramate for epilepsy, should not stop taking the medication prior to seeking advice from a specialist, as doing so may cause their seizures to start again, happen more often or last longer. If planning to conceive, women should make an appointment with their GP to discuss their treatment options.
In 2021 CHM concluded that, of the antiepileptic medicines reviewed for use in pregnancy, lamotrigine and levetiracetam are considered safer, since they were not associated with birth defects if used in pregnancy.
Other recommendations made by the CHM include updates to the topiramate product information leaflet, to fully reflect the available data on the risks of use during pregnancy.
A visual warning symbol will be added to the box of all topiramate medicines. This ‘no’ symbol will show a pregnant woman in a red circle with a line through it. This will be accompanied by warning text about the risks.
Suspected adverse drug reactions associated with topiramate, should continue to be reported to the Yellow Card scheme.
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Notes to editors
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Further information is available in the Drug Safety Update
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Medicines and Pregnancy Registry – updated figures to September 2023. Antiepileptic use in females aged 0 to 54 in England: April 2018 to September 2023
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Topiramate is indicated in the prophylaxis of migraine and in the treatment of epilepsy. It is available as tablets, a liquid oral solution and as capsules that can be swallowed whole or sprinkled on soft food. The brand name of topiramate is Topamax, and so this may also appear on the box.
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Following a comprehensive review of the safety of antiseizure medications in pregnancy, including topiramate, new safety advice was published in January 2021. Since then, new study data has become available suggesting a potential increased risk of autism spectrum disorder and effects on learning development in children exposed to topiramate during pregnancy. Data from around 4.5 million mother-child pairs were examined and this included 24,825 children (0.6%) who were prenatally exposed to antiepileptic drugs. Of these, 16,170 were born to mothers who had epilepsy. These new data, along with data suggesting increasing use of topiramate in women of childbearing age, triggered a new safety review. This review examined the available data on the risk of congenital malformations, effects on growth and development of the baby, and the risk of neurodevelopmental disorders when topiramate is used during pregnancy.
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The review concluded that the use of topiramate during pregnancy is associated with significant harm to the unborn child (both from the confirmed risks of congenital malformations and low birth weight and an approximately 2 to 3 times increased risk of intellectual disability, autistic spectrum disorders and attention deficit hyperactivity disorder).
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Prior to the new safety review, due to the serious known harms associated with the use of topiramate during pregnancy (the higher risk of congenital malformations and low birth weight) , it was already recommended that topiramate must not be used to prevent migraine in patients who are pregnant.
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A previous Drug Safety Update for topiramate was issued in July 2022 announcing the new safety review.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating a medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
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For media enquiries, please contact newscentre@mhra.gov.uk or 020 3080 7651.