Medicine and device safety updates: 29–30 October 2026

This review brings together 30 official materials from nine regulators: product-information updates, risk-minimisation measures, recalls and medical-device communications. The review period is 29–30 October 2026; source decisions may have earlier dates.

The review may be useful to QPPV, LQPPV and LCPPV professionals. The applicability of communications and professional responsibilities should be assessed in the relevant jurisdiction.

EMA

Carvykti: post-infusion monitoring

EMA clarifies post-infusion monitoring arrangements for ciltacabtagene autoleucel: the treating physician determines the setting. Required monitoring periods and proximity to a qualified centre remain applicable. The risk management plan was updated to version 8.3.

Official source: EMA

Qarziba: clinical data and risk management update

Results from APN311-304, APN311-202 and APN311-201 are reflected in updated information for dinutuximab beta. Sections 4.8, 5.1 and 5.2 of the summary of product characteristics were revised, and the risk management plan was updated to version 11.0.

Official source: EMA

Jubereq: injection-site reactions

Following a cumulative safety review and reference-product assessment, injection-site reactions were added to the adverse-reaction information for denosumab. Additional clinical-study information was also incorporated.

Official source: EMA

Dimethyl fumarate Mylan: risk management plan classification

The risk management plan was aligned with Tecfidera version 17, including changes to selected important-risk and missing-information categories. A change in risk-plan classification does not by itself establish that the underlying hazards have disappeared.

Official source: EMA

Ayvakyt: paediatric ROVER study data

The EMA assessment addresses the ROVER avapritinib study in 29 children with central nervous system tumours. The objective response rate was 0%; short exposure prevented establishment of safety, and pharmacokinetic data were insufficient. These findings concern the population studied.

Official source: EMA

Sogroya: lipoatrophy and lipohypertrophy in children

In the published somapacitan assessment, EMA requests a type II variation to include lipoatrophy and lipohypertrophy in the adverse-reaction information for children. The assessment date precedes its publication in this review period.

Official source: EMA

ANSM

Afiveg/Mynzepli in France: pre-filled syringe recall

ANSM reports a patient-level recall of aflibercept batches 2461572 and 2393229. The syringe finger-grip problem may lead to needle movement, eye injury or incomplete dose delivery. Three ocular adverse events were reported in two other EU countries; no French cases are stated in the communication.

Official source: ANSM

Aerstent TBY: delivery system

A material-tolerance issue in the delivery system may increase deployment force, prevent deployment or interrupt a procedure. Affected references and lots should be isolated and returned as specified by the manufacturer. The stent itself and already implanted stents are not affected.

Official source: ANSM

i-STAT hs-TnI: falsely elevated results

Abbott describes reduced resistance to analytical interference in certain lots, including macrotroponin and heterophile antibodies. The letter reports 79 potentially associated complaints, including six unnecessary catheterisations. There is no evidence of falsely low results. Continued use is permitted under the letter’s conditions; suspected interference should be investigated using an updated A26 lot or another validated laboratory method.

Official source: ANSM

CyFlow CD3 Pacific Blue: replacement instructions

Some units were supplied with revision 2 instructions instead of the current revision 3. The manufacturer reports that the product remains compliant and the risk is low, with no related serious incidents or interpretation errors reported. Users should obtain and use the current instructions.

Official source: ANSM

Engage: skipped mandatory questions on iOS

Rapid repeated taps on iOS may skip mandatory questions, producing incomplete scores or missed alerts. The notice provides for a software correction and concerns versions from 7.19 onward. ANSM published the card on 29 October; the letter is dated 22 September.

Official source: ANSM

MHRA

Lercanidipine 10 mg: incorrect strength in a carton

MHRA announces a pharmacy and wholesaler recall of batch M2510877 after a 20 mg blister from batch M2510831 was found in a 10 mg carton. Hypotension and related symptoms are possible, although the overall risk is assessed as low. The official advice is to check the blisters and contact a pharmacy rather than take an incorrect 20 mg blister.

Official source: MHRA

Mynzepli in the United Kingdom: two-batch recall

MHRA reports a pharmacy and wholesaler recall of aflibercept 40 mg/mL batches 2325742 and 2325726 because the pre-filled syringe finger-grip geometry may affect administration. No additional patient action is required. The UK action has a different scope from the French recall.

Official source: MHRA

BfArM/PEI

Gamunex 10%: batch recall following hypersensitivity reports

The precautionary recall concerns batch G04L046403, 400 mL vials, expiring on 31 March 2029. Increased reports include pruritus, erythema, urticaria and dyspnoea. Manufacturing tests have not identified abnormalities explaining the cause, and investigation continues. The affected batch should be quarantined and returned, and must not be dispensed or administered.

Official source: BfArM/PEI

TGA

TGA: warning about unapproved nicotine gum

TGA warns about unlawfully supplied, unapproved nicotine gum. Authenticity, ingredients and actual nicotine content cannot be confirmed, and some products advertise high strengths. The regulator highlights nicotine toxicity, dependence and particular risks to children.

Official source: TGA

PMDA/MHLW

PMDA: proper use of GLP-1 and GIP/GLP-1 receptor agonists

PMDA reiterates use within approved indications. Safety and efficacy for off-label cosmetic weight loss have not been established. Reported events include severe vomiting, ketosis/ketoacidosis, hypoglycaemia and pancreatitis; the reports do not provide incidence estimates. For vomiting or inability to eat or drink, the official alert recommends immediate discontinuation and medical attention. The English material was posted on 30 October; the Japanese original prevails.

Official source: PMDA/MHLW

Health Canada

Health Product InfoWatch: October issue

The bulletin published on 29 October includes a recap of September communications and new information sections on MedSafetyWeek, 2–8 November, and the conditional authorisation of Hernexeos (zongertinib). Recapped September communications should be read with their original dates.

Official source: Health Canada

RotaFlow Console: battery charging

A software issue may stop battery charging after the console has operated on battery power. The official card considers all marketed devices affected. Users are directed to the manufacturer for further information.

Official source: Health Canada

OptiCross: flushing and air management

Boston Scientific’s advisory updates flushing, device preparation and air-management instructions for OptiCross intravascular ultrasound catheters. It applies only to the products listed in attachment 1 of the customer letter.

Official source: Health Canada

Philips Azurion: imaging unavailable at start-up

Voltage surges at start-up or restart may cause power supplies in certain Azurion systems to fail. The system may then fail to complete start-up, making imaging unavailable for clinical use.

Official source: Health Canada

VITROS A1c: positively biased results

Certain generations of slides may generate positively biased results. As of 15 October, QuidelOrtho had received 58 complaints with no adverse events reported. The Canadian card lists seven affected lots.

Official source: Health Canada

TGA

[18F]MK-6240: residual acetonitrile

Residual acetonitrile in batch MK6240-261027a was out of specification. A class II hospital-level recall was initiated. According to the communication, the affected product was not administered to patients.

Official source: TGA

Caelyx: crimp closure defect

The correction concerns batch 5I021D, 50 mg/25 mL, expiring on 30 April 2027. A crimp defect may allow the closure to detach, creating occupational exposure and risks if used, including infection. Overall risk is assessed as low, with no adverse events reported. The card specifies a product correction.

Official source: TGA

Invega: needle blister damage

Affected Invega Sustenna, Trinza and Hafyera products expiring through September 2027 may have damaged needle blisters, potentially compromising sterility. The correction calls for inspection and avoidance of damaged needles. No Australian complaints have been reported.

Official source: TGA

Nature’s Sunshine Andrographis: consumer recall

The class I consumer recall concerns batch 2212, expiring in October 2028, following ongoing reports of andrographis-associated anaphylaxis. This is a product-specific action addressing an already recognised risk.

Official source: TGA

Philips Allura Xper: frozen or blank imaging

R8.1.x and R8.2.x systems with FlexVision may display frozen or blank images, risking procedural complications or inadequate treatment. One death is reported as potentially associated; causation has not been established. The action includes a software correction and the manufacturer’s interim measures.

Official source: TGA

Brilliance MRSA 2: incorrect culture medium

Lot 4567009 may contain the wrong medium, potentially producing false-positive or false-negative results. The action provides for destruction or return and review of affected results.

Official source: TGA

Southern Implants: incorrect item in a TSH1 lot

TSH1 lot 113W13D7 actually contains TSUZ3 items. Procedural delays and replacement may be required; no patient harm is reported. Affected items should be quarantined and returned.

Official source: TGA

Roszdravnadzor

Granogen: inconsistent strengths on carton and vial

Roszdravnadzor reports that batch 090626, manufactured by R-Pharm with PHARMAPARK as marketing authorisation holder, bears 300 micrograms on the carton and 480 micrograms on the vial. The letter requires measures to address the threat to life and health and notification of territorial authorities. Information on measures taken must be entered in the information system within 30 days of publication.

Official source: Roszdravnadzor

AEMPS

AEMPS: August–September bulletin

Published on 29 October, this bulletin summarises August–September information. Topics include atypical fractures with alendronate, belzutifan safety, liver injury with ivacaftor regimens, haemophagocytic lymphohistiocytosis and progressive multifocal leukoencephalopathy with lenalidomide, breastfeeding information for relugolix and anaphylaxis with mycophenolate. It also covers risk-minimisation material updates. This is a retrospective bulletin for the stated months.

Official source: AEMPS