The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing stringent new safety measures for topiramate, also known by its brand name Topamax, following a comprehensive safety review prompted by recent European studies.
The Commission on Human Medicines (CHM) reviewed data from studies highlighting increased risks associated with topiramate use during pregnancy. Findings indicated that children born to mothers who used topiramate during pregnancy face a significantly elevated risk—approximately 2 to 3 times higher—of intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder.
As a result of these findings, the MHRA is advising healthcare professionals against prescribing topiramate for the treatment of epilepsy during pregnancy unless there are no suitable alternative treatments available. Additionally, topiramate is already contraindicated for migraine treatment during pregnancy due to its known association with an increased risk of birth defects.
Pregnancy Prevention Programme Requirements
To mitigate these risks, the MHRA has established a Pregnancy Prevention Programme for topiramate. Key requirements include:
Women of childbearing potential must use effective contraception throughout topiramate treatment.
A pregnancy test is mandatory before initiating topiramate therapy.
Healthcare professionals are required to discuss the risks of topiramate use during pregnancy with patients and have them complete a risk awareness form.
Patients should be informed that certain birth control methods may be less effective while taking topiramate, and they should consult their GP or sexual healthcare practitioner to determine the most suitable contraceptive method.
Regular medication reviews, at least annually, are recommended to monitor treatment efficacy and potential risks.
New safety and educational materials have been introduced for both patients and healthcare professionals to ensure the effective implementation of these measures.
Usage and Impact
Topiramate is commonly prescribed to prevent migraines or manage epilepsy, with recent data from NHS England indicating it is prescribed to over 30,000 female patients under 55 years old per month.
Prior Knowledge and Enhancements
Before this review, topiramate was already known to carry significant risks during pregnancy, including an increased likelihood of birth defects and low birth weight. Patients were previously advised against using topiramate during pregnancy and encouraged to use highly effective contraception during treatment. The Pregnancy Prevention Programme aims to further strengthen safety measures and reduce the incidence of topiramate-exposed pregnancies.
Important Considerations
Pregnant women currently taking topiramate for epilepsy should not discontinue the medication without consulting a specialist, as abruptly stopping treatment may lead to increased seizure activity. For women planning pregnancy, it is crucial to discuss treatment options with their GP to ensure optimal management.
Safer Alternatives
The CHM identified lamotrigine and levetiracetam as safer alternatives among antiepileptic medications reviewed for use during pregnancy in 2021. Unlike topiramate, these medications were not associated with birth defects when used during pregnancy.
Additional Recommendations
Other recommendations from the CHM include updates to the topiramate product information leaflet to reflect comprehensive data on pregnancy risks. A visual warning symbol—a red circle with a pregnant woman inside and a line through it—will also be added to all topiramate medicine packaging to underscore these risks.
Reporting Adverse Reactions
Healthcare professionals and patients are encouraged to report any suspected adverse drug reactions associated with topiramate to the Yellow Card scheme to facilitate ongoing monitoring and safety enhancement.
These measures underscore the MHRA’s commitment to ensuring the safe use of topiramate and minimizing risks associated with its use during pregnancy. For further information and updates, healthcare professionals and patients are advised to consult updated product information and seek guidance from healthcare providers.
