The MHRA's October round-up shows where children's medicines are most exposed
A missing QT warning, particles in a medicine that protects children on cisplatin from hearing loss, an under-strength unlicensed liquid and a ketone strip shortage all touched paediatric care this month. None was a new pharmacological signal, and most were about product quality and information.
In brief
The MHRA's October 2026 safety round-up covers guanfacine labelling, a Pedmarqsi recall, under-strength clopidogrel liquids and ketone strip supply.
- Neuraxpharm wrote to prescribers because QT prolongation information was missing from its guanfacine product information.
- Two batches of Pedmarqsi were recalled in the UK over a risk of particulate matter.
- Unlicensed Xeal clopidogrel oral liquids contained 76% of the required dose after a formulation error.
The Medicines and Healthcare products Regulatory Agency published its monthly Safety Roundup on 27 October 2026, in the run-up to #MedSafetyWeek, which runs from 2 to 8 November. Among the routine notices were several that bear directly on paediatric practice.
None of them describes a newly discovered drug risk. Taken together, they point to the weaker links in the supply of children's medicines: copies of product information, specialist hospital products, unlicensed liquids and the near-patient tests that sit alongside treatment.
A gap in guanfacine labelling
Neuraxpharm UK wrote to healthcare professionals on 9 October, in agreement with the MHRA, because important safety information on QT/QTc interval prolongation was missing from the Summary of Product Characteristics for its guanfacine prolonged-release tablets. The tablets are used for attention deficit hyperactivity disorder in children and adolescents aged six to 17 for whom stimulants are unsuitable, not tolerated or ineffective.
The letter says QT prolongation is an uncommon adverse reaction, and that dose reduction or discontinuation should be considered, on clinical judgement, in patients who develop it. Takeda's Intuniv already carries similar wording in its product information.
Particles in Pedmarqsi
On 12 October the MHRA issued a Class 2 recall, at pharmacy and wholesaler level, for two batches of Norgine's Pedmarqsi 80 mg/mL solution for infusion. Routine stability investigations had identified a risk of particulate matter. No related adverse reactions were reported, and other batches remain available, with staff told to inspect vials.
Spain's AEMPS said on 20 October that particles had been confirmed in three lots, different from the UK batches, supplied there through early access. It put their size at about 81 to 604 µm. The medicine, used to prevent hearing loss, is given to patients aged one month to 18 years receiving cisplatin for localised solid tumours.
An under-strength liquid
The most striking notice came on 26 October. Xeal Pharma recalled all strengths of its unlicensed clopidogrel oral suspension and solution, at patient level, after a formulation error left affected batches with 76% of the required amount of clopidogrel. The MHRA noted that no licensed clopidogrel oral liquids are available, and tagged the notice for paediatrics and neonatology among other specialties.
Pharmacists were told to contact patients, or everyone dispensed the product from 20 July 2026 where batch traceability is lacking. Patients should not stop treatment suddenly, because of the risk of serious thrombotic events. The MHRA said harm was not anticipated in long-term preventive use, although patients would not receive their full prescribed dose.
Where no licensed liquid exists, a formulation error reaches patients with little to catch it.
Ketone testing under pressure
A device safety notice on Nova Biomedical's StatStrip ketone test strips, first published on 9 October and updated on 16 October, warned of quality-control failures and said replacement stock was not expected in the UK for about four weeks. Where supply is constrained, the MHRA told services to prioritise testing for those at greatest risk, naming paediatric patients. NICE recommends near-patient blood ketone measurement when diabetic ketoacidosis is suspected in children and young people.
For manufacturers, the common thread is that paediatric exposure often arises in small, specialised products where a single failure has few substitutes.
