1. MHRA: interim monitoring for Duvyzat after international death reports
The MHRA published interim advice on 5 November for Duvyzat (givinostat), a black-triangle histone deacetylase inhibitor used in Duchenne muscular dystrophy, after several deaths were reported internationally in patients taking the medicine; no UK deaths have been reported. A November 2025 DHPC had already flagged the cases. The agency has decided on product-information updates that would tighten ECG and electrolyte monitoring, but an independent review is still under way before those label changes are finalised. In the meantime, clinicians should continue to avoid use in patients at higher ventricular-arrhythmia risk, follow Duchenne Care UK (North Star) ECG timing (baseline, within 2–4 weeks, then every 6 months), add 24-hour ambulatory ECG at baseline and once on a stable dose, and check serum potassium, magnesium and calcium on the same schedule as haematology (every 2 weeks for the first 2 months, at month 3, then every 3 months). All suspected adverse reactions should be reported on a Yellow Card. For PV teams, the update is a live example of interim risk minimisation while a formal label change is pending independent review. MHRA Drug Safety Update, 5 Nov 2026
2. Novartis reports nine tumours after Zolgensma; two show vector integration
Novartis confirmed on 5 November that, since Zolgensma (onasemnogene abeparvovec) was first approved in 2019, it has received nine reports of tumours in patients previously treated with the AAV9 gene therapy for spinal muscular atrophy; more than 6,000 patients have been treated across trials, managed access and commercial use. In two of the cases there was evidence of vector DNA integration into the patient's DNA; both patients were treated for the tumour and continue to be monitored. The company states that the potential risk of tumours from vector integration is already described in the prescribing information, that health authorities were notified in each case, and that it continues to work with regulators on next steps. SMA Europe said regulators are assessing the evidence and urged timely public communication; UK multidisciplinary guidance cited by SMA UK currently recommends no change to routine follow-up. Safety teams supporting AAV programmes should expect heightened scrutiny of long-term malignancy follow-up, integration analyses and community communication. SMA Europe / Novartis statement, 5 Nov 2026
3. TGA lab testing: Synedica peptide products do not match their labels
Australia's TGA published laboratory results on 5 November for Synedica-branded unapproved peptide products seized with NSW Police. Tested BPC 157 & TB 500 10 mg, KLOW 80 mg and BARBIE KLOW 100 mg showed no detectable TB-500 despite label claims; Synedica Retatrutide 10 mg contained less retatrutide than labelled, with marked sample-to-sample variation. Retatrutide remains investigational and is not approved by the TGA or any comparable regulator. Consumers are told to stop using Synedica peptides, return remaining product to a pharmacy for disposal, and report suspected adverse events; the agency has elevated unapproved peptides as a priority enforcement area. The findings add analytical confirmation to the grey-market peptide risk already flagged by Medsafe, and reinforce that spontaneous reports for "retatrutide" or other peptides may not reflect a verified product. TGA safety alert, 5 Nov 2026
4. FDA: septic reactions still occur after pathogen-reduced or tested platelets
On 5 November FDA reminded blood establishments, transfusion services and device manufacturers that septic transfusion reactions can still follow apheresis platelet transfusion despite pathogen reduction or bacterial testing. Since May 2025 the agency has received reports of septic reactions, including two fatalities after pathogen-reduced platelets and two fatalities after platelets prepared with other bacteria-mitigation strategies. Suspected reactions should be reported immediately to the blood supplier; confirmed fatal complications must be notified to FDA, and voluntary MedWatch reporting of nonfatal septic reactions is encouraged. Device manufacturers remain under 21 CFR Part 803 reporting duties. Investigations should be case-specific and may include retaining the isolate and contacting CBER. For haemovigilance and PV interfaces, the notice underlines residual sepsis risk and the need for thorough root-cause work rather than assuming a previously reported mechanism. FDA CBER safety communication, 5 Nov 2026
5. Anvisa: e-Notivisa will take medicine quality complaints from 9 November
Brazil's Anvisa announced on 4 November that from 9 November its e-Notivisa system will accept technical complaints about medicines, not only devices, cosmetics, hygiene products, sanitisers and foods. Anyone with a CPF and an active GOV.BR account can report suspected quality, presentation or storage problems even when no harm has occurred (for example broken tablets, leaking bottles, unusual appearance, particles, label mismatches or device-associated dosing issues). Personal data stay protected from the company; if use of the medicine caused harm, users are directed to Vigimed instead. Marketing authorisation holders with Brazil exposure should expect more structured quality-complaint inflow alongside adverse event reporting and align complaint and PV triage accordingly. Anvisa notice, 4 Nov 2026
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