Home Health Introduction of Enhanced Pregnancy Prevention Measures for Topiramate

Introduction of Enhanced Pregnancy Prevention Measures for Topiramate

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Following a comprehensive safety review prompted by a recent European study, the MHRA is implementing enhanced safety protocols for topiramate, marketed as Topamax.

The Commission on Human Medicines (CHM) assessed findings revealing that children born to mothers using topiramate during pregnancy face a heightened risk—approximately 2 to 3 times higher—of intellectual disability, autism spectrum disorders, and attention deficit hyperactivity disorder.

Based on CHM recommendations, the MHRA now advises healthcare providers against prescribing topiramate for epilepsy during pregnancy unless no suitable alternative exists. Additionally, due to established links with birth defects, topiramate was already contraindicated for migraine treatment during pregnancy.

To comply with a Pregnancy Prevention Programme, women of childbearing potential must use effective contraception throughout topiramate treatment and undergo a pregnancy test before starting therapy. Healthcare professionals are required to discuss pregnancy risks with patients and ensure completion of a risk awareness form as part of this programme.

Patients should be informed that certain contraceptives may be less effective while using topiramate, and they are encouraged to consult their GP or sexual healthcare provider for guidance on suitable options. Regular medication reviews, minimally annually, are also recommended. Updated safety and educational materials have been distributed to support healthcare providers and patients in implementing these measures.

Topiramate, used to prevent migraines or manage epilepsy, is prescribed to approximately 30,000 women under 55 years old monthly in England, according to NHS England data.

Before this review, topiramate was known to carry risks of significant harm during pregnancy, including increased birth defect and low birth weight risks, prompting previous advisories against its use during pregnancy and emphasizing effective contraception during treatment. The Pregnancy Prevention Programme aims to further bolster safety measures and reduce instances of topiramate-exposed pregnancies.

Women currently using topiramate for epilepsy who are pregnant or planning pregnancy should not discontinue medication without consulting a specialist, as stopping may exacerbate seizure frequency or intensity. Women planning pregnancy should schedule a GP consultation to discuss treatment options.

In 2021, CHM concluded that lamotrigine and levetiracetam are safer options among reviewed antiepileptic medications during pregnancy, as they were not associated with birth defects.

Additional CHM recommendations include updating topiramate product information leaflets to reflect comprehensive pregnancy risk data and affixing a visual warning symbol—a ‘no’ symbol featuring a pregnant woman within a red circle with a line through it—on all topiramate packaging, accompanied by cautionary text.

Healthcare professionals and patients are urged to continue reporting suspected adverse reactions associated with topiramate to the Yellow Card scheme.