New Safety Measures introduced for Topiramate prescribing
Following a review by the Medicines and Healthcare products Regulatory Agency (MHRA) the use of Topiramate is now contraindicated in the following situations:
- in women of childbearing potential unless the conditions of the Pregnancy Prevention Programme are fulfilled (for all indications)
- in pregnancy for prophylaxis of migraine
- in pregnancy for epilepsy unless there is no other suitable treatment
The aim is to ensure that all women of childbearing potential use highly effective contraception and exclude pregnancy before starting Topiramate.
Healthcare professionals will receive materials by post in the coming weeks to support discussions with patients and the implementation of the Pregnancy Prevention Programme. These materials are also available online and consist of:
- Patient Guide for Migraine and Epilepsy - to be provided to all girls and women of childbearing potential who are started on, or continue to use, topiramate-containing medicines
- Guide for Healthcare Professionals for Migraine and Epilepsy
- Risk Awareness Form for Migraine and Epilepsy - for the healthcare professional and the patient (or responsible person) to sign at initiation of treatment with topiramate and at annual treatment reviews.
- Patient Card - to be given by pharmacists to all female patients who are dispensed topiramate to inform them of the risks
A visual warning symbol will be added to packs of Topiramate. This symbol will show a pregnant woman in a red circle with a line through it, with warning text about the risks and information about the new measures.