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Duvyzat®▼ (givinostat): interim advice on risk mitigation measures following reports of deaths in patients while taking givinostat

There have been several reports internationally of deaths in patients with Duchenne muscular dystrophy (DMD) while being treated with Duvyzat® (givinostat). Following a review of these cases and associated evidence, the MHRA has proposed updates to the product information.

From:
Medicines and Healthcare products Regulatory Agency
Published:
5 November 2026
Therapeutic area:
Cardiovascular disease and lipidology, Neurology, Paediatrics and neonatology and Pharmacy
Published:
5 November 2026

Summary

There have been several reports internationally of deaths in patients with Duchenne muscular dystrophy (DMD) while being treated with Duvyzat® (givinostat). Following a review of these cases and associated evidence, the MHRA has proposed updates to the product information. Interim monitoring advice is being provided by the MHRA based on these proposals, pending independent review and finalisation of the MHRA’s position.

  Advice for Healthcare Professionals:

  • continue to refrain from using Duvyzat® in patients at increased risk for ventricular arrhythmias, such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or those taking other medicines known to cause QT prolongation
  • continue to follow the Duchenne Care UK (North Star) clinical guidance, which provides information on cardiac monitoring and clinical monitoring
  • obtain ECGs before initiating treatment, within 2-4 weeks after starting givinostat, and then every 6 months thereafter, in line with Duchenne Care UK (North Star) clinical guidance. The guidance also provides advice on thresholds for cardiology input. Additionally, the MHRA advises that 24-hour ambulatory ECG monitoring should also be undertaken at baseline, and repeated when the patient is on a stable dose of medication
  • the MHRA also advises that 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 thereafter
  • Duvyzat®▼ (givinostat) is a black triangle medicine and is subject to additional monitoring. Report ALL suspected adverse drug reactions associated with Duvyzat® on a Yellow Card

Advice for Healthcare Professionals to Provide to Patients:

  • a small number of deaths have been reported outside the UK in people with Duchenne muscular dystrophy while taking Duvyzat® (givinostat). No deaths have been reported in the UK. The MHRA has reviewed the available information and is providing interim advice on the frequency of monitoring (such as ECGs or blood tests), pending finalisation of an independent review
  • the proposed changes to monitoring aim to ensure that Duvyzat® remains as safe as possible for all Duchenne muscular dystrophy patients
  • continue taking Duvyzat® as prescribed and attend all appointments. Tell your doctor about any additional medications you are taking or if they change
  • speak to your specialist Duchenne’s team if you have any concerns about your treatment
  • Duvyzat®▼ (givinostat) is a black triangle medicine and is subject to additional monitoring. Report ALL suspected adverse drug reactions associated with Duvyzat® on a Yellow Card

Background

In November 2025, the Marketing Authorisation holder of Duvyzat® (givinostat) issued a Direct Healthcare Professional Communication (DHPC) informing healthcare professionals that a number of deaths have been reported internationally in patients with Duchenne muscular dystrophy (DMD) who were being treated with Duvyzat. No deaths have been reported in the UK.

The MHRA has reviewed these cases and based on this, the licensing authority has reached a decision on its review of Duvyzat® (givinostat). This includes updates to the monitoring requirements contained within the product information, including more frequent ECG and electrolyte measurements. Implementation of this decision is subject to an ongoing independent review. The MHRA will consider the independent review report before any amendments to the product information are made. A further DSU will be issued to communicate any finalised product information changes.

In the meantime, healthcare professionals are reminded to follow the current monitoring requirements and warnings in the product information. Duvyzat® can cause prolongation of QTc, so its use should be avoided in patients at increased risk for ventricular arrhythmias, such as those with congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or those taking other medicines known to cause QT prolongation.

In addition, healthcare professionals are reminded that they should continue to follow the Duchenne Care UK (North Star) clinical guidance on cardiac and clinical monitoring. The guidance advises that in all patients, ECGs should be obtained prior to initiating treatment, within 2-4 weeks after starting Duvyzat®, and then every 6 months. ECGs can also be requested as clinically indicated and at dose changes. The guidance also provides advice for QTc thresholds for not initiating Duvyzat®, cardiology input and treatment cessation. In addition to the existing clinical guidance, the MHRA advises that 24-hour ambulatory ECG monitoring should also be undertaken at baseline, and repeated when the patient is on a stable dose of medication.

The MHRA also advises that serum electrolytes (including potassium, magnesium and calcium) should be monitored at the same frequency as haematological bloods, when initiating and during treatment with Duvyzat®, every 2 weeks for the first 2 months of treatment, at month 3, and then every 3 months thereafter.

Reporting advice

Duvyzat®▼ (givinostat) is subject to additional monitoring. Healthcare professionals, patients, and caregivers are asked to submit reports using the Yellow Card scheme electronically using: 

When reporting suspected adverse drug reactions, please provide as much information as possible, including information about medical history, any concomitant medication, onset timing, and treatment dates.

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Duvyzat®▼ (givinostat): interim advice on risk mitigation measures following reports of deaths in patients while taking givinostat

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Stakeholder engagement

  • NHS England National Patient Safety Team
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Article citation: MHRA Drug Safety Update volume 20, issue 4: November 2026: 1

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