On 5 November 2026, the Medicines and Healthcare products Regulatory Agency (MHRA) published interim advice for healthcare professionals and families regarding monitoring for people taking Duvyzat® (givinostat). This includes recommendations for additional heart monitoring and blood tests while an independent review is completed.
The advice follows the MHRA’s review of reports and available evidence relating to a small number of serious incidents reported outside the UK. Importantly, no such incidents have been reported in the UK.
The MHRA has emphasised that these additional measures are precautionary and are intended to help ensure that givinostat continues to be used safely as possible for people living with Duchenne muscular dystrophy.
If you/your child are taking givinostat,
- Continue taking it as prescribed
- Attend scheduled monitoring appointments
- Keep your clinical care team informed about all medicines you/your child are taking and let them know about any changes to these medications.
- Follow the advice of the specialist clinical teams.
Givinostat received conditional approved from MHRA for the treatment of Duchenne muscular dystrophy in December 2024. Givinostat was subsequently accepted for restricted use within NHS Scotland by the Scottish Medicines Consortium in December 2025 and was recommended by National Institute for Health Care Excellence (NICE) for use within NHS England in May 2026.
You can read the full MHRA update here.
Any additional information or comments received from healthcare professionals will be added to this update as they become available.
If you have any questions or concerns about your treatment, please speak with your specialist Duchenne care team. If you would like a wider conversation following this news, please give us a call on 07535 498 506 or email us at support@actionduchenne.org. If you have any questions about the science, research, or the information shared in this update, please feel free to contact our Science Team at science@actionduchenne.org, who will be happy to support you.
We recognise that treatment updates can sometimes feel worrying. If you have concerns, your specialist clinical team remains the best source of advice for your individual circumstances.
