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MHRA announcement raises new concerns over epilepsy care


SUDEP Action is reviewing new MHRA safety guidelines which state topiramate (brand names Topamax and Topiragen) should not be prescribed to women of childbearing age unless the conditions of a Pregnancy Prevention Programme are fulfilled.

Topiramate is used to treat epilepsy and migraines. It now follows sodium valproate as an anti-seizure medicine in restrictive measures because of concerns over reproductive harms. The update follows a MHRA review which found the use of topiramate during pregnancy to be associated with harm to the unborn child.

SUDEP Action has previously instigated three official requests for a national review – or national scrutiny of the Prevent Programme – because there is no additional resource available for safe implementation. Levels of awareness about SUDEP and epilepsy risk are dangerously low; there are currently long waits for treatment and shortages of medicines supplies.

The UK is also uniquely impacted by the MHRA’s requirement for two clinical signatures.

Following this week’s MHRA announcement, SUDEP Action is reviewing the new Topiramate regulations and materials, along with speaking to women – who are not planning pregnancies – who are frightened by the MHRA announcement and the impact it may have on their epilepsy care and their ability to control their seizures.

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