PharmacovigilanceOfficial

MHRA issues interim monitoring advice for Duvyzat after international reports of deaths in DMD patients

🇬🇧 MHRA Drug Safety Update · Thu 05 Nov 2026

The UK regulator proposes more frequent ECG and electrolyte checks for givinostat, with implementation subject to an ongoing independent review; no deaths have been reported in the UK.

The MHRA has published interim advice on risk mitigation for Duvyzat (givinostat), the Duchenne muscular dystrophy (DMD) treatment, following several international reports of deaths in patients taking it. The advice appears in Drug Safety Update volume 20, issue 4, dated 5 November 2026. The agency stresses that no deaths have been reported in the UK.

According to the MHRA, the marketing authorisation holder sent a Direct Healthcare Professional Communication in November 2025 about the deaths reported abroad. The agency has since reviewed the cases and the associated evidence, and the licensing authority has reached a decision that includes changes to the monitoring requirements in the product information, including more frequent ECG and electrolyte measurements. Implementation remains subject to an independent review, and the MHRA will consider that report before amending the product information. A further Drug Safety Update will announce any finalised changes.

In the interim, the MHRA advises 24-hour ambulatory ECG monitoring at baseline, repeated once the patient is on a stable dose. It also advises monitoring serum electrolytes, including potassium, magnesium and calcium, at the same frequency as haematological bloods: every two weeks for the first two months, at month three, and every three months thereafter. This sits alongside the Duchenne Care UK (North Star) guidance, which recommends ECGs before starting treatment, two to four weeks after initiation and then every six months, and sets out thresholds for cardiology input.

Clinicians are reminded that Duvyzat can prolong the QTc interval and should be avoided in patients at increased risk of ventricular arrhythmias. Examples given are congenital long QT syndrome, coronary artery disease, electrolyte disturbances, or use of other medicines known to prolong the QT interval. For patients and carers, the MHRA says to keep taking Duvyzat as prescribed, attend all appointments, report any change in other medicines to their doctor and raise concerns with the specialist Duchenne team.

Duvyzat carries a black triangle and is under additional monitoring. The MHRA asks healthcare professionals, patients and carers to report all suspected adverse reactions through the Yellow Card scheme, including as much detail as possible on medical history, concomitant medicines, onset timing and treatment dates.

What it means for your team

  • PV teams should check that Yellow Card and other case-handling processes capture the detail the MHRA requests: history, concomitant medicines, onset timing and treatment dates.
  • Regulatory affairs staff should track the independent review and the further Drug Safety Update, since final product information changes are not yet confirmed.
  • Teams responsible for risk communication should review how the November 2025 DHPC and the new interim advice reach UK prescribers and Duchenne care teams.
  • Medical and quality functions should note that the MHRA's ambulatory ECG and electrolyte advice goes beyond the current North Star guidance.

Official source: MHRA Drug Safety Update ↗

Article written by VigiEye from the official source (MHRA Drug Safety Update). AI-assisted; check the source before acting.

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