Deaths reported abroad, none in the UK: the new monitoring advice for a Duchenne medicine
What happened
On 5 November 2026 the Medicines and Healthcare products Regulatory Agency (MHRA) published new safety advice about a medicine called Duvyzat. Its other name is givinostat, and it is used to treat Duchenne muscular dystrophy, usually shortened to DMD. The notice appeared in Drug Safety Update, the bulletin the regulator uses to tell doctors, nurses and pharmacists about new risks. The reason is serious. Several deaths have been reported internationally in people with DMD who were being treated with Duvyzat. The MHRA is clear about one thing: no deaths have been reported in the UK. The MHRA has reviewed these cases and proposed changes to the medicine's product information, the official leaflet and prescribing document. Those changes are not final. An independent review is still going on, and the MHRA will read it before making any changes. Another Drug Safety Update will follow. In the meantime the MHRA has issued interim monitoring advice. In plain terms: while we finish checking, here is how closely people on this medicine should be watched. Two things are now asked for more often: - A 24-hour ECG. An ECG records the heart's electrical activity. Patients already have standard ECGs before starting, two to four weeks after starting, then every six months. The MHRA now advises an extra kind as well, a 24-hour ambulatory ECG worn during a normal day. It should be done at the start, and again once the patient is on a steady dose. - More blood tests for salts. Doctors should check potassium, magnesium and calcium, known as electrolytes, every two weeks for the first two months, again at month three, then every three months. One message is repeated for families, and it is worth reading twice. Patients should keep taking Duvyzat as prescribed and attend all appointments. This is not a recall, and the medicine has not been withdrawn.
Why this matters
DMD is rare. The MHRA says around 100 boys are born with it each year in the UK, and about 2,500 people are living with it at any one time. It almost always affects boys and those assigned male at birth. It is a muscle wasting condition. A protein called dystrophin does not work properly, so muscle fibres break down and are replaced by fibrous or fatty tissue. Muscles weaken over time. For a long time there was very little to offer. Duvyzat was conditionally approved in the UK in December 2024 for patients aged six and over, with all genetic variants of DMD. For many families that was a big moment, so a safety notice about it lands heavily. A headline putting "deaths" next to the name of a medicine your child takes is frightening, and the detail is more measured than that. What is changing is the level of watchfulness, not the availability of the treatment. The MHRA says the proposed changes "aim to ensure that Duvyzat remains as safe as possible for all Duchenne muscular dystrophy patients". The word "remains" is doing real work in that sentence. There is a heart reason behind the extra checks. Duvyzat can cause QTc prolongation. The QTc, measured from an ECG, shows how long the heart takes to reset electrically between beats. If that gap stretches too far, it can raise the risk of a dangerous heart rhythm. Low potassium, magnesium or calcium can stretch it too, which is why blood salts are being checked more often.
What the evidence actually says
It is worth being precise here, including about what is not known. The MHRA's update does not publish a figure for how many deaths were reported. It describes "several reports internationally" and, in its patient advice, "a small number of deaths" outside the UK. No count is given, so anyone quoting a specific number is not taking it from this notice. More importantly, cause has not been established. The MHRA refers to deaths "in patients with Duchenne muscular dystrophy while being treated with Duvyzat". "While being treated with" is not the same as "caused by". DMD itself carries a risk of heart and breathing complications, which is part of why cardiac monitoring is already standard. Separating the effect of a medicine from the effect of the illness is difficult, and that is the job the independent review is doing. This is also not out of the blue. In November 2025 the company holding the licence sent a Direct Healthcare Professional Communication to UK clinicians about these international reports, and the MHRA has been reviewing the cases since then. The 5 November notice is the next step in a process already under way. The original approval was conditional, and still is. It rested on a randomised, double-blind, placebo-controlled study lasting 18 months in 179 patients with DMD who could still walk. Those given givinostat took significantly less time to climb four stairs than those given a placebo, and worsened less on a standard movement measure. More data is still required, including for patients who are no longer walking. Side effects affecting more than one person in ten were already known at approval: tummy pain, a fall in blood platelet count, which can make bleeding more likely, diarrhoea, raised triglycerides, fever, feeling sick and being sick. One standing caution has not changed. Duvyzat should not be used in people at higher risk of a dangerous heart rhythm: those with congenital long QT syndrome or coronary artery disease, those whose blood salts are disturbed, and those taking other medicines known to prolong the QT interval. Clinicians are also asked to keep following Duchenne Care UK (North Star) clinical guidance, which sets out cardiac monitoring and when a cardiologist should be involved.
Qurexa perspective
We want to be straightforward about this one. Duvyzat is a specialist medicine, started and supervised by a hospital neuromuscular team. It is not something a community pharmacy delivery service like ours dispenses, and nothing here should be read as an offer to supply it. Questions about this medicine belong with your specialist Duchenne team. What we do recognise is the pattern underneath the story. This notice does not ask anyone to change a dose. It asks for more monitoring, and monitoring only works if the blood test actually gets done and the ECG appointment actually gets attended. For a family already managing a lot of appointments, that is a real burden rather than an afterthought. The other part is knowing every medicine a person takes. The risk flagged here involves other medicines that affect heart rhythm, and blood salts that some medicines can shift. That makes an accurate, up-to-date list genuinely safety-relevant, including anything bought over the counter. That is the honest overlap with what we do: helping people keep on top of the medicines they are already prescribed.
Practical advice
If you or your child takes Duvyzat, here is what the advice means in practice. - Keep taking it as prescribed. The MHRA advises continuing treatment and attending all appointments. Do not stop or change the dose on your own. - Expect extra checks. Ask your specialist team about the 24-hour ECG, and about blood tests for potassium, magnesium and calcium. - Say what else you take. Tell your team about any other medicines, including anything bought without a prescription, and tell them when those change. - Take questions to the specialists. If you are worried, speak to your specialist Duchenne team rather than relying on social media. - Report side effects. Duvyzat is a black triangle medicine, meaning it is under extra monitoring, and the MHRA wants to hear about all suspected side effects, not just unusual ones. Patients, carers and healthcare professionals can report through the Yellow Card scheme, on its website or app. Include as much detail as you can: medical history, other medicines, when things started, and treatment dates. One general point, not from the MHRA notice but sensible for anyone on a medicine that can affect heart rhythm. If you faint, feel your heart racing or thumping, or feel suddenly and severely dizzy, get medical advice promptly. In an emergency, call 999.
What to know
The short version: - On 5 November 2026 the MHRA issued interim safety advice on Duvyzat (givinostat), a medicine for Duchenne muscular dystrophy, after several deaths were reported internationally in patients taking it. - No deaths have been reported in the UK. - The medicine has not been recalled or withdrawn. Patients are advised to keep taking it as prescribed and attend all appointments. - The change is more monitoring: a 24-hour ECG at the start and again on a stable dose, plus blood salt checks every two weeks for two months, at month three, then every three months. - Cause has not been established. The MHRA's wording is that the deaths happened while patients were being treated, and an independent review is ongoing. - Final changes to the product information are still to come, and the MHRA will publish another update when they are settled. - Duvyzat is a black triangle medicine. Report all suspected side effects through the Yellow Card scheme. Sources: MHRA, "Duvyzat (givinostat): interim advice on risk mitigation measures following reports of deaths in patients while taking givinostat", Drug Safety Update volume 20, issue 4, published 5 November 2026, https://www.gov.uk/drug-safety-update/duvyzat-r-v-givinostat-interim-advice-on-risk-mitigation-measures-following-reports-of-deaths-in-patients-while-taking-givinostat; MHRA, "Givinostat conditionally approved to treat patients with Duchenne muscular dystrophy (DMD)", published 20 December 2024, https://www.gov.uk/government/news/givinostat-conditionally-approved-to-treat-patients-with-duchenne-muscular-dystrophy-dmd; MHRA Yellow Card scheme, https://yellowcard.mhra.gov.uk/. This article is for general information and does not replace advice from a doctor, pharmacist or other qualified healthcare professional. If you or your child takes Duvyzat, do not change or stop treatment without speaking to your specialist Duchenne team.
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