MHRA tightens safety measures for topiramate by introducing a new pregnancy prevention programme
Healthcare professionals in the UK are being advised to avoid prescribing the migraine and antiseizure medication topiramate, commonly known by the brand name Topamax, to women and girls unless they fulfil the requirements of a Pregnancy Prevention Programme.
This guidance follows new safety measures introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) following a major safety review, which highlighted a potential increased risk of neurodevelopmental disabilities in children exposed to topiramate during pregnancy.
The Commission on Human Medicines (CHM) evaluated studies that examined the risks associated with using topiramate during pregnancy. These studies indicated that children born to mothers who took topiramate during pregnancy had an approximately 2 to 3 times higher risk of intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder.
Based on CHM's recommendations, the MHRA now advises that topiramate should not be prescribed for treating epilepsy during pregnancy unless there is no suitable alternative.
To meet the criteria of the Pregnancy Prevention Programme, women of childbearing age must use effective birth control throughout their treatment and take a pregnancy test before starting topiramate. Healthcare professionals should inform patients about the risks of using this medication during pregnancy, and completing a risk awareness form is a mandatory part of the programme.
Patients are also warned that some birth control methods may be less effective when used alongside topiramate. They are advised to consult with their GP or sexual healthcare practitioner to determine the most suitable birth control method for them. Additionally, the MHRA recommends conducting regular medication reviews, at least once annually.
The agency has introduced new safety and educational materials to assist both patients and healthcare professionals in implementing these measures effectively.
Topiramate, which is used for migraine prevention and epilepsy management, is available in various forms, including tablets, a liquid oral solution, and capsules that can be swallowed whole or sprinkled on soft food.
Recent data from NHS England indicate that just over 30,000 female patients under 55 in England were prescribed topiramate in one month.
Even before the CHM review, the use of topiramate during pregnancy was linked to an increased risk of birth defects and low birth weight. Therefore, patients were advised against its use during pregnancy and encouraged to use highly effective contraception while on the medication.
With the introduction of the Pregnancy Prevention Programme, the MHRA aims to further strengthen these safety measures and reduce the number of topiramate-exposed pregnancies.
However, the MHRA has cautioned that pregnant women or those planning to become pregnant who are currently taking topiramate for epilepsy should not discontinue the medication without consulting a specialist, as “doing so may cause their seizures to start again, happen more often or last longer.”
Women taking topiramate who are planning to conceive are advised to discuss alternative treatment options with their doctor.
