The MHRA has recently made several important updates to the UK Product Information for Diacomit (stiripentol):
- Long-term use and adult inclusion: The Product Information now explicitly acknowledges long-term use and includes adults in the posology section, supporting continued treatment for adults with Dravet syndrome.
- Lifted dietary restriction: The previous restriction on use with milk and dairy products has been removed.
- Updated mechanism and interactions: The description of the mechanism of action and drug interactions has been revised for clarity.
- Removal of acidic degradation statement: The warning regarding degradation in acidic conditions has been removed from the official documentation.
While these MHRA updates are significant, in the BNF and NICE guidelines, stiripentol is not yet formally licensed for new initiations in adults. Whilst prescription for adults may still be considered “off-label”, the updated MHRA information supports continued and new use in adults under specialist supervision. Specialists are encouraged to review current prescribing practices in light of these updates. DSUK hopes that the updates will provide clearer, more accurate information and support better access and care for people living with Dravet syndrome.