Medicine and device safety updates: 23 October 2026
36 official materials in 35 topic groups from 7 regulatory sources. The review covers medicine and device actions, assessment outcomes and pharmacovigilance procedures. Publication and original document dates are identified separately.
The review may support QPPV, LQPPV, LCPPV and other pharmacovigilance professionals. Applicability depends on local rules and the responsibilities of each role.
Health Canada
Medium importance
Nitrofurantoin — DRESS / cutaneous vasculitis
Health Canada found insufficient evidence to establish a link between nitrofurantoin and DRESS or cutaneous vasculitis. Monitoring continues; no new mandatory labelling action was announced.
Roszdravnadzor
High importance
Zolgensma (onasemnogene abeparvovec): educational materials
Educational materials for healthcare professionals and caregivers address hepatotoxicity including acute liver failure, thrombocytopenia and thrombotic microangiopathy, with baseline and follow-up monitoring. This is risk minimisation for known risks, rather than a newly announced signal.
High importance
Ibuprofen Welfarm 200 mg: two-batch recall
The manufacturer recalls 200 mg tablet batches 0530225 (10×5) and 2690825 (10×2) for dissolution non-compliance. The letter explicitly requests measures to remove a threat to life and health. The cited 25 September letter No. 02И-1108/26 is background.
High importance
Tanacehol 50 mg: recall of 14 batches
A recall covers 14 batches of 50 mg tablets for dissolution non-compliance; five batches also failed the assay specification. The letter is dated 21 October and the card appeared on 22 October. The official attachment gives the complete batch list.
EMA
Medium importance
Vevzuo (denosumab)
An updated RMP version 1.1 and procedural history were published. Post-authorisation data refine risk characterisation in line with the reference medicine Xgeva; this does not establish a new risk.
High importance
Vydura (rimegepant)
Documents published on 22 October reflect the daily preventive regimen, a medication-overuse headache warning and RMP updates. The earlier anaphylaxis warning is not presented as a new change in this release.
High importance
Amyvid (florbetapir (18F))
Adverse-reaction frequencies and injection-site terminology were updated using pooled data from 48 trials; hypersensitivity is described as very rare. The newly published documents report an earlier procedure.
High importance
Filgrastim — Zarzio and Filgrastim Hexal
The aortitis warning is broadened to arteritis of large and medium-sized vessels, with associated signs, symptoms and adverse-reaction table changes.
Official source — Zarzio (filgrastim)
High importance
Taxotere (docetaxel)
The documents add psoriasis, including recurrence or worsening of pre-existing disease, with unknown frequency, and provide polysorbate 80-related updates. Previously established skin reactions are not all new changes.
Medium importance
Byfavo (remimazolam)
The juvenile-rat neurotoxicity assessment was published. It found no additional safety findings changing the approved nonclinical profile; the obligation is fulfilled and no new clinical restriction is imposed.
Low importance
CHMP PROM — residual-solvent guidance process
The newly published April PROM minutes record an April decision to consult on revised Annex I of ICH Q3C residual-solvent guidance. This discloses an earlier safety-policy process, not a new October requirement.
Low importance
Tevimbra (tislelizumab) — proposed extension
The procedure list records a proposed 150 mg every 2 weeks or 300 mg every 4 weeks regimen and submitted RMP version 10. This is an application under evaluation, not an approved regimen or a new signal.
ANSM
High importance
OptiCross IVUS — Boston Scientific
Air-management instructions specify that a catheter with suspected air must be removed before additional flushing; it must not be flushed inside the patient. The action addresses air embolism risk and is not a recall.
High importance
Tukit 30618/30628 — Infomed
Batches 66033826 (TU30618) and 66043826 (TU30628) have swapped MEDOPEN 10/30 labels, potentially reducing DFPP effectiveness. Inspection and correction are required; no injury was reported in the described case and no blanket recall was announced.
Medium importance
Widex Allure ARRD2 — WS Audiology
Some deliveries lacked the instructions for use and/or safety manual. Recipients must be contacted and supplied with the missing documents containing warnings and contraindications.
High importance
FreeStyle Libre 3 / Libre apps — Abbott
Replacement letters supersede the earlier immediate-update advice. Users of Libre 3 version 3.6.7 or earlier and Libre version 1.4.0 or earlier should wait for a corrected version and confirm glucose with a meter before treatment decisions. Users of 3.6.8/1.4.1 may continue normal use, enable the signal-loss alarm, and use a meter during prolonged signal loss or when readings do not match symptoms, following the latest official letter.
High importance
LUISA LM150TD ventilator — Löwenstein
A battery-communication fault in firmware 1.15.0018 may cause shutdown and interruption of ventilation. The manufacturer requires updating to 1.15.0020 or later and specifies interim measures; no known field injuries were reported.
High importance
Abre venous stent — Medtronic
Updated manual-deployment instructions address partial deployment. There were 31 reports (0.015%), including additional interventions; no deaths or life-threatening events were reported. The action covers all models and lots and is not a recall.
Medium importance
JAK inhibitors — prescribing conditions
For five JAK inhibitors, mandatory hospital initiation is removed and relevant community specialists may initiate and renew treatment. Existing high-risk population restrictions and risk-minimisation measures remain; no new class signal is announced.
Medium importance
Verkazia / Ikervis (ciclosporin 1 mg/mL)
When Verkazia is unavailable, exceptional temporary substitution with Ikervis is permitted without a new prescription for children aged 4 and older and adolescents, retaining the prescribed Verkazia dosage. Inform the prescriber and patient, document substitution and supply the required information. Supply is limited to 15 days; do not substitute the adult Ikervis regimen.
TGA
High importance
Eagle / MediHerb Andrographis products
A Class I consumer recall covers the listed Andrographis medicines and all their unexpired batches following continuing anaphylaxis reports. These are new operational details of an established ingredient-related action.
Medium importance
Olympus EVIS EXERA III GIF-XP190N
A Class II correction concerns serial 2135405 and a potentially loose bending component after repair. Pre-use inspection and repair arrangements are required; four complaints and no adverse events were reported.
Medium importance
Cyclotek FDG injection batch 4210-4146
A Class III product alert concerns activity/volume above the labelled amount in batch 4210-4146. The batch expired on 13 October; customers were notified and an investigation is ongoing. A confirmed medicine-quality defect is not asserted.
High importance
Grappler R3FLEX P82-001-1237-SK
A Class II recall/product alert addresses a missing pre-tied knot and risk of inadequate fixation in the two listed lots. Quarantine/return and monitoring of implanted patients are required. One complaint and no adverse events were reported.
High importance
Hologic Horizon-WI DXA
A Class II correction addresses an unvalidated VGA cable and possible electromagnetic interference, including with active implants. Affected patients/operators are instructed to refrain from use until remediation. There were 24 complaints and no injuries.
High importance
BD Safe-T-Centesis PIG1260K/PIG1280K
A Class II recall covers all unexpired lots of the listed kits for foreign material with irritation/inflammation risk. Stop use and dispose of affected devices; no Australian adverse events were reported.
High importance
Schiffa SCP100/SCP111, MED20260922
A Class II recall covers lot MED20260922 for possible non-sterility and infection risk. Quarantine affected kits and contact the supplier; no adverse events were reported.
High importance
VITROS A1c slides 6844520
A Class II recall concerns positive HbA1c bias confirmed for GENs 05, 38, 42, 45, 46, 48 and 49. The card includes a broader lot table also containing 43 and 44. Determine the action scope from the complete official table and instructions rather than conflating the two lists.
ANVISA
High importance
Fauldleuco (calcium folinate 10 mg/mL), lot 25D0808
ANVISA imposed a precautionary interdiction on lot 25D0808 over suspected particles while safety is investigated. This is a temporary measure for one lot, rather than a recall of the manufacturer’s entire portfolio.
High importance
Counterfeit Accu-Chek Active strips
Sale, distribution, import and use of identified counterfeit strips offered without outer packaging and marked ONLY FOR GOVERNMENT TENDER are prohibited. The action does not imply a defect in genuine Accu-Chek products.
High importance
Counterfeit Lauton NAC supplement, lot 11-2025
The same article separately identifies counterfeit Lauton NAC supplement lot 11-2025, expiry 11/2026. Precautionary interdiction and sale, distribution and use restrictions apply; distinguish the counterfeit from genuine products.
Medium importance
Polilaminina — official clarification
ANVISA clarified polilaminina’s experimental status and, in the regulator’s assessment, the absence of reliable safety data. The authorised phase I trial had not begun; compassionate-use monitoring concerns do not establish causality for individual outcomes.
China: CDR/CDE
Low importance
Pharmacovigilance Express 10/2026 (total 282)
The newly appearing Chinese bulletin republishes September FDA information on ADZYNMA neutralising antibodies and MHRA information on falsely elevated digoxin results with certain immunoassays during apalutamide/enzalutamide treatment. These are regulatory republications, not new Chinese signals.
Low importance
IVD clinical-use risk monitoring — training
A training communication concerns clinical-use IVD risk monitoring, risk assessment and post-market vigilance. It describes surveillance-system development and contains no new product-specific warning.
Low importance
Nonclinical vaccine evaluation — draft consultation
CDE opened a one-month consultation on draft nonclinical vaccine evaluation guidance addressing toxicology, ADE/VED and issues specific to new platforms. It is a draft, not an adopted guideline.