MHRA Issues Interim Safety Advice for Duvyzat® (Givinostat) Following Reports of Deaths in Duchenne Muscular Dystrophy Patients

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued interim monitoring advice and proposed updates to the product information for Duvyzat® (givinostat). This action follows several international reports of deaths in patients with Duchenne muscular dystrophy (DMD) who were being treated with the drug. Healthcare professionals are advised to continue refraining from using Duvyzat® in patients at increased risk for ventricular arrhythmias, such as those with congenital long QT syndrome, coronary artery disease, or electrolyte disturbances. The MHRA also recommends obtaining ECGs before initiating treatment, within 2-4 weeks after starting givinostat, and every 6 months thereafter, in line with Duchenne Care UK clinical guidance. Additionally, 24-hour ambulatory ECG monitoring should be undertaken at baseline and repeated when the patient is on a stable dose, and serum electrolytes should be monitored regularly.