Medicine and device safety updates: 22 October 2026
- 22-10-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review brings together 32 verified materials from nine regulators: warnings, batch actions, risk-management updates and safety-assessment methods. The number of materials is not the number of new clinical safety signals.
For QPPV, LQPPV, LCPPV and PV specialists. Professional role names and responsibilities vary by jurisdiction.
EMA — European Medicines Agency
Alendronate — atypical fractures of other bones
Following the PRAC assessment, CMDh considers a causal relationship with atypical fractures of bones other than the femur at least a reasonable possibility. Product information is to add a warning about fractures such as those of the ulna and tibia during long-term treatment and an adverse reaction of unknown frequency. Suspected atypical fractures require an individual benefit–risk evaluation, including consideration of treatment discontinuation. Translations are due on 1 November and submission of variations on 31 December 2026. Benefit–risk remains unchanged subject to the information updates.
Rayvow — published paediatric assessment
EMA publishes the Article 46 assessment of PIONEER-PEDS1/2 in patients aged 6 to under 18. According to the marketing authorisation holder, as reported in the EMA assessment, the programmes ended for business reasons unrelated to quality or safety concerns. The final assessment concludes that no further regulatory action is necessary and the issue is fulfilled. This publication does not establish a newly approved paediatric indication or a new safety signal.
Anzupgo — adolescent use and RMP follow-up
The variation covers moderate to severe chronic hand eczema in patients aged 12 years and older when topical corticosteroids are inadequate or inappropriate, with updates to relevant SmPC sections. RMP version 2.0 includes PASS NIS-DELGO-2406 addressing non-melanoma skin cancer during long-term use on the hands and wrists. CHMP opinion was adopted on 17 September and the European Commission decision on 16 October. A planned safety study does not by itself establish a newly confirmed risk.
Libmeldy — updated risk-management plan
RMP version 5.0 updates the development-study programme following completion of study 201222 and programmes CUP 207394, CUP 206258 and HE 205029. The RMP data lock point is 16 December 2024 and sign-off is 6 July 2026. Long-term follow-up continues. Completion and removal of studies from the plan do not imply that long-term monitoring requirements have ended.
Cavoley — initial EPAR, product information and RMP
EMA publishes the initial assessment, product information and risk-management plan for this pegfilgrastim biosimilar. The assessment is dated 23 July and authorisation was issued on 25 September 2026. Additional monitoring and the approved risk-minimisation arrangements apply. The RMP is version 1.1, signed on 10 April 2026, with a 30 March data lock point. First publication of these documents is not evidence of a newly emerging adverse reaction.
MSSG — supply and patient-safety coordination
Newly published minutes of the 23 September meeting discuss influenza-vaccine delivery delays: the overall expected supply was sufficient but would arrive later. They also describe stabilised ifosfamide and cyclophosphamide supply in 2026 and planning for 2027. These are the recorded September discussions, not newly occurring shortages on the publication date.
CHMP January PROM — cardiovascular safety and impurities
The newly published minutes cover safety qualification of non-mutagenic impurities and adoption of the draft reflection paper on cardiovascular safety of anticancer medicines for a six-month public consultation. The meeting took place on 19 January and the document is dated 29 January 2026. The minutes do not open a new October consultation.
CHMP February PROM — nitrosamines and development methods
The February minutes address the revised active-substance chemistry guideline, including the cohort of concern and nitrosamines, together with topics in paediatric oncology development and the microbiome. They document the February work programme; they should not be treated as a new product-specific October safety action.
Network Data Steering Group — ADR data quality
The July minutes discuss data assets for medicines regulation, including adverse-drug-reaction data quality. They are relevant to pharmacovigilance data governance. The document is dated 21 July for the 17 July meeting; the consultation timing mentioned in the minutes relates to the earlier work programme, not a new invitation in October.
Network Data Steering Group — regulatory data quality
The September minutes cover the Product Management Service data roadmap and real-world-data priorities. They provide process context for consistent regulatory and pharmacovigilance data, rather than a product-specific safety signal. The meeting took place on 10 September and the cover is dated 29 September 2026.
CEVIRA — evidence limitations and follow-up recommendations
The expert panel states that further clarification of the intended population and additional data are necessary before a positive benefit–risk conclusion can be supported. It recommends precise indications and warnings, diagnostic exclusion of higher-risk or invasive disease, and stronger prospective monitoring of oncological and reproductive outcomes. The opinion concerns a restricted, non-excisional treatment context and is not a recall or a marketing-authorisation decision.
APTURE — preliminary assessment and long-term evidence
The expert panel considers the notified body’s assessment methodologically appropriate and the preliminary safety and performance evidence supportive. It nevertheless notes that ALT-FLOW II is ongoing and that sustained benefit and long-term safety require confirmation. Planned post-market follow-up includes approximately 150 patients with at least two years of follow-up. This is not a definitive long-term safety conclusion.
HMPC — public assessment-summary template
The newly published final template provides a structure for understandable public summaries of herbal-medicine assessments, including the committee’s conclusions on use and safety. It was adopted on 24 September 2025. A general template does not announce a new safety concern for any individual herbal product.
GMP/GDP Q&A — batch traceability in parallel trade
The October revision of Chapter 5 question 4 explains batch numbering on relabelled or repacked parallel-traded medicines. Traceability between the original batch and any additional trader identifier must be maintained; both numbers must appear in recall information where an additional number is used. The guidance warns that unrelated numbers may cause confusion, particularly for patients, during a recall.
EURD list — PSUR schedules updated
Revision 165 updates PSUR frequency, data lock points and related reporting entries. The change-date column marks 111 rows with 21 October 2026. New entries include metaraminol, ensitrelvir, obicetrapib and a separate topical dexamethasone entry. Marketing-authorisation holders should check the exact substance-specific row and deadlines. Removal of an entry from this list alone does not establish a safety-related market withdrawal.
Roszdravnadzor — Russia
Eylea — patient risk-minimisation materials
Roszdravnadzor published four patient brochures covering diabetic macular oedema, wet age-related macular degeneration, retinal vein occlusion and myopic choroidal neovascularisation. The first three cover the 2 mg and 8 mg presentations; the myopic CNV brochure covers 2 mg. These are risk-minimisation materials, rather than evidence of a newly identified October safety signal.
Ranvek (upadacitinib) — professional and patient materials
The Russian communication provides healthcare-professional and patient materials on established risks, including serious infections and tuberculosis, embryo-fetal toxicity, major cardiovascular events, venous thromboembolism, malignancy and gastrointestinal perforation. The materials have global versions dated February 2025 and local approval in September 2026. Their new publication should not be read as discovery of all these risks in October.
Health Canada — Canada
Femyso — incorrectly packed cartons
Health Canada reports that lot NR02557A-R (DIN 02560569), supplied by Lupin Pharma Canada, may contain two green mifepristone cartons or two pink misoprostol cartons instead of one of each. The product contains mifepristone 200 mg and misoprostol 200 micrograms. Follow the official instructions and consult a healthcare professional about the affected pack and treatment.
Azurion 7 — SSDs installed during service
Philips reports that non-specified solid-state drives installed during repair or service may cause loss of imaging or motorised movement, a black display, or inability to store images. The Canadian Type II recall covers 22 entries in the official affected-product table. Users should check model and serial numbers against that table and contact the manufacturer for further instructions.
i-STAT hs-TnI — falsely elevated troponin results
Abbott identifies reduced mitigation of analytical interference, including macrotroponin and heterophile antibody interference, in lots beginning A24, A25, B25, B26, C26 and D26 (catalogue 09P81-25). The issue may produce falsely elevated cardiac troponin I results. Health Canada explicitly states that there is no evidence of falsely low results caused by this issue. Consult the manufacturer for further information.
TGA — Australia
BioPractica ImmunePro Plus — Andrographis recall details
TGA provides operational details for the Class I consumer recall linked to anaphylaxis reports associated with Andrographis-containing medicines. Affected ImmunePro Plus 60-tablet batches are 41309 (expiry 28 February 2027), 43660 (31 March 2028) and 45266 (30 January 2029), ARTG 393514. Consumers should not use affected products and should follow return/refund instructions. These details supplement the previously announced Andrographis action.
Ethical Nutrients and Metagenics — Andrographis batches
The Class I consumer recall covers all batches not expired as of 20 October 2026 of Ethical Nutrients Immune Defence (30, 60 and 90 capsules), Metagenics Andro NK (40), Gut InflamX (60) and Immune Active NK (40). ARTG entries are 351799, 382592, 447722 and 470385. The action addresses the established Andrographis anaphylaxis concern; do not use affected products and follow the official return instructions.
EchoTip Ultra — incorrect needle in a labelled pack
All five ECHO-HD-19-A units from lot C2415199 (order G52012; ARTG 163822) are recalled because one contains an EchoTip ClearCore ECHO-BX-22 from lot C2416756 and cannot be identified from the labelling. TGA describes possible irritation, minor mucosal trauma or perforation with a minor self-limited bleed requiring intervention during the procedure. Cook Medical reports no complaints of related patient harm. Quarantine and return affected devices.
PD-L1 IHC 22C3 pharmDx — electronic IFU formatting error
For GE006 lots 11992577B, 12001736B and 12010368B (ARTG 397615), eIFU revision 02 omitted hyphens: tissue-section thickness appeared as 45 µm instead of 4–5 µm and slide-storage temperature as 28°C instead of 2–8°C. Use revision 03. Laboratories should review whether their sectioning or storage practices were changed because of revision 02 and, if so, review previously generated data under their internal procedures.
Vaper Empire VE Nicotine — prohibited ingredient
TGA testing detected cinnamaldehyde, prohibited under TGO 110, in Spearmint e-liquid 6 mg/mL, 30 mL, batch 2507-33-13 (expiry July 2027; VG-2024-NTF-01734). The Class II consumer recall directs users to stop using affected stock and contact MyDuke for return or safe disposal and credit. The product is ARTG-exempt as a notified good.
Medsafe — New Zealand
Tenofovir disoproxil Viatris — temporary UK supply
The New Zealand letter covers UK-sourced 300 mg tablets, batch 8222253, relabelled with New Zealand-compliant labels. Formulation is unchanged; the tablet debossing is TN245 instead of TM300. Both supplies may circulate concurrently for approximately two months. This communication helps prevent confusion during the temporary supply change.
Comirnaty XFG — Canadian-labelled vials for ages 5–11
The temporary supply is the 10 microgram/0.3 mL single-dose vial for children aged 5–11 years. Formulation, dose and indication are unchanged. Canadian QR codes and contact information differ; the Canadian expiry notation 2027-SE means September 2027. The letter specifies frozen storage at −90 to −60°C and, after thawing, storage at 2–8°C for no more than 10 weeks. Use the New Zealand data sheet.
HSA — Singapore
Dantrium 20 mg injection — visible foreign particles
Singapore HSA announces a Class 1 retail-level recall of Dantrium 20 mg powder for solution for injection (dantrolene), batch 80681, supplied by Alliance Pharm. The reason is visible foreign particulate matter. Stop supply and return affected stock as directed. The recall classification describes potential seriousness; it does not establish that patient injury has occurred.
MHRA — United Kingdom
CE-marked devices — consultation outcome and surveillance
The UK government intends legislative changes for indefinite recognition of devices certified under EU MDR/IVDR and alignment of relevant EU MDD transitional arrangements through 31 December 2028. UK responsible-person, registration and post-market surveillance obligations remain. MHRA describes Yellow Card reporting, safety-signal exchange and publication of device-safety information. Legislative changes remain subject to parliamentary approval; this response does not itself put the planned changes into force.
Ukraine State Expert Center
Ibrutinib — implementation of the PRAC assessment
Ukraine SEC publishes safety-information changes following the PRAC meeting of 6–9 July 2026. The material concerns progressive multifocal leukoencephalopathy (rare), cough (very common) and associated product-information and risk-management changes. PML monitoring continues; the next PSUR is to include cumulative reviews of haemophagocytic lymphohistiocytosis and pancreatitis. The Ukrainian attachment identifies Imbruvica 140 mg, UA/14220/01/01. This is publication of an earlier European assessment.
Depression trials — Ukrainian safety-assessment guidance
Ukraine adopts guidance aligned with EMA/CHMP/185423/2010 Rev.3 of 20 January 2025. Section 3.6 covers adverse events, psychiatric and cognitive effects, overdose, suicidality, metabolic and cardiovascular risks, withdrawal, long-term safety and special populations. Suicidal thoughts and behaviour should be actively assessed using validated methods across age groups. The guidance is recommendatory and permits scientifically justified alternative approaches.
Anvisa — Brazil
Ashwagandha — Brazilian regulatory clarification
Anvisa states that the promoted supplement is not registered in Brazil and that ashwagandha is not an authorised ingredient for food supplements. Manufacturing, marketing, distribution and use of unauthorised products are prohibited. The information article does not cite a new product-specific enforcement resolution. Reports of harm discussed in media are not presented here as proof of causality.