MHRA proposes tighter ECG and electrolyte checks for Duvyzat after reports of deaths abroad

What happened

On 5 November 2026 the MHRA published a Drug Safety Update with interim advice on risk mitigation for Duvyzat (givinostat). The trigger was international reports of deaths in patients with Duchenne muscular dystrophy (DMD) who were taking the medicine. The regulator proposes more frequent ECG and electrolyte checks.

Two qualifiers matter. First, the measures are proposals, and their implementation is subject to an ongoing independent review. Second, the MHRA states that no deaths have been reported in the UK. The advice responds to overseas information, not to a domestic cluster.

What the record does not tell us

The available material does not give the number of deaths, the countries involved, the patients' ages or circumstances, or the timing relative to treatment. It does not state a cause of death or establish that givinostat caused any of them. It does not say who is conducting the independent review or when it will report. Teams should not fill these gaps with assumptions.

The choice of ECG and electrolyte monitoring suggests the regulator is focused on cardiac safety. That is an inference from the measures chosen, not a stated finding, and the mechanism has not been confirmed in the material we have.

Why it matters for pharmacovigilance

The case shows a regulator acting on signals from outside its own jurisdiction. With no UK deaths, the MHRA still chose to publish interim advice rather than wait for the review to conclude. For marketing authorisation holders and PV teams, a safety concern anywhere can quickly become a requirement to explain and mitigate everywhere.

The proposal also tests the link between risk minimisation and clinical practice. More frequent ECG and electrolyte checks add visits, tests and coordination for prescribers, families and clinics. In a rare paediatric-onset disease where patients are often managed in specialist centres, these checks affect clinic capacity. Whether the interim advice is workable will show in how quickly centres can adopt it.

Interim advice that depends on a review's outcome is also a communications problem. Clinicians need to know what to do now while understanding that the position may change. Safety communications that state clearly what is proposed, what is unknown and what is under review serve that need best.

Regulatory context

The contrast with the week's routine EMA outputs is useful. On 5 November the EMA published PSUSA outcomes for diethylamine-salicylate/escin and for ethinylestradiol/gestodene, both with a regulatory outcome of maintenance of authorisations. These are scheduled, periodic single assessments that conclude through a defined process. The Duvyzat advice is different: it is event-driven, provisional and tied to an ongoing review. It is a reminder that periodic reporting cycles do not capture fast-moving signals.

Other items from the same days are not connected to givinostat but show the breadth of vigilance work. The EMA issued a Q&A for MAHs on the CHMP nitrosamine opinion under Article 5(3) (EMEA-H-A5(3)-1490). The Dutch inspectorate IGJ published a Helena Laboratories field safety notice on the V8 UltraCE analyser, and Spain's AEMPS warned about certain Likorall ceiling patient lifts. Separately, the MHRA published its 2026-2030 plan to embed patient and public involvement in regulation, building on the 2021-2025 strategy. The record does not link that plan to Duvyzat, but it is relevant background for how the regulator may engage patients and carers when communicating safety questions.

Who is affected and what to watch

The most directly affected are prescribers and patients in the UK, and any company responsible for givinostat's safety. Clinicians managing DMD patients will need to consider how the proposed monitoring fits their current schedules. Whether other regulators issue similar advice is not yet known.

Watch for four developments: the outcome and timing of the independent review; whether the MHRA confirms, amends or drops the proposed monitoring; any UK reports that change the current picture of no deaths; and any actions by other regulators in response to the same international reports. Until then, the evidence is limited to the MHRA's published interim advice.