The Medicines and Healthcare products Regulatory Agency has issued interim advice on risk mitigation for Duvyzat (givinostat) following several reports internationally of deaths in patients with Duchenne muscular dystrophy while being treated with the drug. No deaths have been reported in the United Kingdom. The marketing authorisation holder first informed healthcare professionals of the international deaths in a Direct Healthcare Professional Communication in November 2025.
The MHRA said it has reviewed the cases and reached a decision on its review, including updates to monitoring requirements in the product information, with more frequent ECG and electrolyte measurements. Implementation is subject to an ongoing independent review, and the agency will consider that report before any amendments to the product information are made. A further Drug Safety Update will communicate any finalised changes.
In the meantime, the interim advice adds to existing Duchenne Care UK (North Star) guidance. ECGs should be obtained before starting treatment, within 2 to 4 weeks after starting, and then every 6 months. The MHRA additionally advises 24 hour ambulatory ECG monitoring at baseline and again when the patient is on a stable dose. Serum electrolytes, including potassium, magnesium and calcium, should be monitored at the same frequency as haematological bloods: every 2 weeks for the first 2 months of treatment, at month 3, and then every 3 months.
Prescribers are reminded to continue to refrain from using Duvyzat in patients at increased risk of ventricular arrhythmias, including those with congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or those taking other medicines known to cause QT prolongation, because givinostat can prolong the QTc interval. Patients are advised to continue taking the drug as prescribed and to attend all appointments.
Duvyzat is a black triangle medicine subject to additional monitoring, and the agency asked that all suspected adverse reactions be reported through the Yellow Card scheme. The open item for the market is the independent review: until it reports, the size of the label change, and any effect on the eligible patient population, remains undecided.