Medicine and device safety updates: 20 October 2026
- 20-10-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Official publications are organized into 44 groups covering 58 communications and documents on medicines, devices and safety methodology. Some update known risks or measures; these are not 44 new signals. Preliminary signals, draft guidance and regulatory actions have different status.
The review may support QPPV, LQPPV, LCPPV and PV specialists in assessing which official communications apply to their products and processes. Role names and responsibilities differ between jurisdictions.
EMA — European Medicines Agency
1. mNexspike: thawed-syringe handling and P301 assessment
Transport and storage information for thawed pre-filled syringes was updated, with an editorial amendment to SmPC section 4.8. Separately, the P301 Japan/Part 3 assessment published on 19 October found no new safety signals in adolescents or adults, required no SmPC changes or further regulatory action and confirmed a positive benefit–risk balance.
2. Orphacol — safety information/documentation
Package leaflet aligned with approved contraindications, interactions, overdose and lifelong treatment information. Risk-communication update, not a new signal.
3. Delstrigo and Pifeltro: DRESS safety-information update
DRESS was added to sections 4.4 and 4.8 following study MK-8591A-053 involving a two-drug doravirine-containing regimen. Counsel and monitor for severe skin reactions; withdraw treatment when suspected and do not restart after SJS/TEN/DRESS as specified in the SmPC. Both products share one procedure; EMA published the update on 19 October 2026.
4. Aflibercept: product-information updates for 12 medicines
EMA published product-level documentation implementing the known PSUSA/00010020/202511 assessment on retinal vasculitis with or without occlusion and corresponding information changes for ophthalmic aflibercept formulations. Updates for 12 products implement one risk assessment; they are not 12 new signals. Products: Opuviz, Yesafili, Vgenfli, Pavblu, Mynzepli, Eyluxvi, Eylea, Eiyzey, Afiveg, Baiama, Eydenzelt, Ahzantive.
Official source 1 Official source 2 Official source 3 Official source 4 Official source 5 Official source 6 Official source 7 Official source 8 Official source 9 Official source 10 Official source 11 Official source 12
5. Siklos — safety information/documentation
The package leaflet adds adult and paediatric posology and missing adverse reactions in line with the already approved SmPC. This is an update to patient information.
6. Febuxostat Viatris (previously Febuxostat Mylan) — safety information/documentation
Risk management plan version 4.1 was aligned with Adenuric: prior safety concerns were removed from its summary, while routine pharmacovigilance and risk minimisation remain. This does not mean risk-free use or removal of approved SmPC warnings.
7. CTIS bitesize talk
Training on CTIS Safety user roles and training-environment access is announced for 18 November 2026, 15:30–17:00 CET. The announcement does not establish new legal duties.
8. Data Quality Framework — ADR draft
The draft ADR data-quality framework describes 5 quality dimensions and 7 improvement areas for human and veterinary reports. Consultation runs from 19 October to 14 December 2026. The framework is descriptive; it does not supersede guidance or create additional requirements.
9. 21st industry PV platform agenda
The agenda for the 21st industry pharmacovigilance platform was updated on 19 October; the meeting is scheduled for 20 October, 13:00–17:30. The agenda is not a regulatory decision and does not establish new GVP obligations.
10. Platform trials — draft reflection paper
Draft platform-trial methodology covers independent data and safety monitoring and benefit–risk evaluation before changing controls. Consultation runs from 19 October 2026 to 31 January 2027. The document does not report a product safety signal.
11. Hypertension guideline revision concept
The concept for revising hypertension-trial guidance includes measurement approaches and safety evaluation. Public consultation runs from 19 October 2026 to 31 January 2027. The document is a draft.
12. Day80 clinical assessment template
Updated template includes clinical safety, RMP and the PV system. An assessment tool, not a new product-risk communication.
13. SmPC section 5.1: methodological assessment principles
Principles for presenting clinically relevant, reliable data and balanced interpretation in SmPC section 5.1 take effect on 1 January 2027. The publication concerns the presentation of information rather than a new clinical risk.
SFDA — Saudi Arabia
14. Apremilast — penile squamous cell carcinoma
Potential association with penile squamous cell carcinoma: 3 global reports, 1 possible and 2 unassessable; IC2.4. Preliminary signal, causality not established.
15. Apremilast — positive Mycobacterium tuberculosis complex test
Positive M. tuberculosis complex test:46 global reports, all unassessable; IC2.7. This does not establish causality or active tuberculosis.
16. Leflunomide — rheumatoid lung
Rheumatoid lung:42 global reports; among 30 reviewed,2 probable,6 possible,2 unlikely,20 unassessable; IC5.4. Preliminary signal alongside known pulmonary toxicity.
17. Prucalopride — suicidal ideation
Suicidal ideation:47 global reports; among 30 reviewed,3 probable,6 possible,2 unlikely,19 unassessable; IC2.8. Preliminary signal, not a new mandatory label change.
18. Apremilast — enthesopathy
Enthesopathy:30 global reports;2 possible,1 unlikely,27 unassessable; IC2.7. Preliminary potential association.
MHRA — United Kingdom
19. Beckman Coulter iQ200/DxU Iris lamina-fluid leakage
A compromised rinse-line check valve may leak lamina fluid, creating slip/fall and minor eye-irritation hazards for staff. The notice states that patient results are unaffected. Inspect for leaks during daily cleaning; stop using a leaking analyser and contact support. Operation may continue if no leakage is observed.
20. bioMérieux EMAG heater timeout
EMAG heater error 10003 cancels extraction and invalidates samples, potentially delaying or preventing results. The notice states that there is no risk of false results. Users may continue operating the system, reinitialize and repeat failed runs; service staff will restore firmware SP4 Patch 1.
21. GE Centricity/Enterprise Archive patient-image mismatch
Historical image migration may associate a study with the wrong patient, leading to misdiagnosis or delayed care; no injuries were reported. Suspend new inbound DICOM migrations. Check permanently embedded patient identifiers and acquisition dates, retain legacy sources and do not interpret images if identity cannot be confirmed.
22. Intersurgical spirometry sets/breathing-system recall
Assembly and functional defects may produce abnormal waveforms or inaccurate physiological measurements. Ventilation and oxygenation are not expected to be compromised. The manufacturer estimates failures in 1 in 1,000 products and a medium patient risk. Immediately quarantine affected codes/lots and arrange return or destruction and replacement. The reply deadline is 13 November 2026; corrective action is due by 31 December 2026.
23. Philips Lumify loss/delay of point-of-care scanning
Unexpected transducer re-registration requires connectivity, while an unstable USB connection may interrupt scanning. Since 2015, Philips has received four reports of death and eight reports of serious injury associated with Lumify being unavailable or nonfunctional at the point of care. These reports do not establish causality in every case. Do not use outside areas with readily accessible Wi-Fi or cellular connectivity; keep backup ultrasound equipment or modalities available. A registration software update is being developed and the cable issue remains under assessment.
24. RayStation dose-deformation clipping
Dose deformation beyond the original grid may clip clinically relevant dose and underestimate accumulated dose, potentially increasing a later treatment dose. No patient mistreatment is known. Check grid margins and deformed dose distributions and inform planning staff. The UK notice schedules a correction for December 2026, subject to market clearance.
25. Tandem t:slimX2 Malfunction16 corrective software
The known speaker-wiring fault may stop insulin delivery and interrupt CGM/mobile data, causing hyperglycaemia that may require hospital treatment. Software 7.10.4 improves early fault detection and adds persistent vibration alerts. Basal-IQ users need diabetes-team approval and training to move to Control-IQ before updating. Maintain backup insulin delivery, glucose checks and the specified alerts. No new hazards are identified in this update.
26. Abbott i-STAT hs-TnI analytical interference
Macrotroponin and heterophile-antibody interference may cause falsely elevated cardiac troponin I results. Abbott reports 79 potentially associated complaints, including six unnecessary cardiac-catheterization interventions; falsely low results have not been demonstrated. Cartridges may remain in use under the notice while transitioning to A26 lots. Interpret results with clinical findings and other tests; serial results may not distinguish interference. If interference is suspected, retest with A26 when available or a validated alternative method.
27. American Orthodontics MRUnsafe labeling
Metal orthodontic devices can cause MRI artefacts or heating that delays diagnosis or treatment. One reported RF-heating event delayed treatment. The MR Unsafe symbol was added in 2024, while older stock may remain in use. The notice describes a known characteristic of metal orthodontic devices, with no design or material change. Share the notice; no stock action or acknowledgement is required.
28. Beckman Coulter SW40/SW41 rotor breakage
A nonconforming rotor microstructure may cause breakage and damage samples or the centrifuge. Confirmed failures were contained by the instrument. Arrange a free replacement and use an unaffected compatible rotor if available. If continued use is necessary, the notice permits it until replacement while acknowledging the damage risk. Use personal protective equipment and standard procedures when handling damaged biological samples.
29. Convatec ESENTA Stomahesive Paste foreign matter
Foreign matter in affected ESENTA paste lots may cause inflammation, infection, irritation, rash or allergy. One foreign-matter complaint and no related adverse events were reported. Stop use and distribution, quarantine and destroy affected stock, notify downstream customers and return the response within 30 days. Patients with unexpected symptoms should contact a healthcare professional.
30. FreiStil LISA LE entrapment hand-control update
An unlocked hand control on LISA LE beds without anti-entrapment protection may allow crushing, strangulation or fatal injury. The triggering incident involved another manufacturer’s bed. Lock the control out of reach, keep the platform at its lowest safe position and prevent access underneath it. Replacement controls with automatic shut-off after 10 seconds of inactivity are planned for the first quarter of 2027; affected beds require the specified upgrade or decommissioning.
31. Baxter/Liko Likorall lift double-fault correction
Motor-shaft breakage combined with reduced Single Fault Safety braking may cause a patient to fall. Since 2016, Baxter has received 252 complaints, five confirmed double faults and one report of serious injury. Arrange an authorised inspection/correction and prefer a mobile lift until inspection. If use continues, apply the additional handling precautions. A separate letter instructs users to discontinue units beyond their labelled ten-year life.
32. Maquet/Getinge nonconforming sevoflurane vaporizers
Nonconforming sevoflurane vaporizers may produce HFIP or hydrogen fluoride, potentially causing respiratory irritation and, in the worst case, pulmonary oedema or systemic effects. Harm may be delayed by 24–48 hours; no injuries were reported. Use may continue under the specified precautions until replacement. Do not retain liquid for more than 30 days or during external transport; empty and dry-run as instructed. The corrective-action target is 5 October 2027.
33. Medtronic Abre partial-deployment workaround
Medtronic reports 31 partial stent deployments (0.015%) through 14 September 2026: 27 with no or negligible harm, one requiring a second endovascular procedure, two surgical conversions and one involving prolonged treatment/chronic pain. No deaths or life-threatening events were reported. The validated manual workaround applies only to partial deployment; do not disassemble if deployment has not started. Updated instructions are pending regulatory approval. No retrieval, disposal or action for previous recipients is requested.
34. NOxBOXi oxygen-sensor irregular readings
The oxygen sensor may show irregular readings or fail zero calibration; one serious injury was reported as potentially associated. The sensor does not control oxygen or nitric-oxide delivery. Follow Attachment D, maintain alternative oxygen monitoring and arrange replacement of affected sensors. If a sensor malfunctions and no alternative monitoring is available, remove the device from service until the sensor is replaced and verification passes.
35. Philips Azurion non-specified SSD correction
Non-specified SSDs installed during repairs may cause loss of imaging, motorised movement or data, delaying intervention or contributing to procedural complications. No harm was reported; serious outcomes are considered improbable. Use may continue under the instructions and manual-movement precautions. Inspections and SSD replacements are expected to start in December 2026; return the response within 30 days.
Health Canada — Canada
36. Dantrium Intravenous — particulate matter
Type I recall for particulate matter in lots 80681, 82413 and 91579 (Knight Therapeutics), distributed nationally. Contact the recalling firm for recall questions and a healthcare professional for health concerns.
37. IQecg Digital ECG — updated recall
Updated Type II recall: incorrect ECG waveforms/heart rate may occur. Manually assess heart rate before therapeutic intervention and follow the specified workaround pending software correction. Originally published28 July, recall date 15 Oct, updated 19 Oct.
TGA — Australia
38. Andrographis: two Australian consumer recalls
Consumer recall of all unexpired lots following continuing anaphylaxis reports with andrographis. Stop use/return; distributors quarantine stock. Follow-up to a known risk, not a new signal. Products: Wagner Professional Immunity Force; Swisse Nutra+ Andro Max and Ultiboost Immune Action.
ANSM — France
39. FreeStyle Libre3 / Libre apps — safety notice
A potential app vulnerability could alter glucose readings/alarms and affect treatment. Update Libre3 versions 3.4.0–3.6.7 to 3.6.8+ and Libre1.4.0 to 1.4.1+. No known exploitation/adverse events as of 9 Oct.
40. HemosIL AcuStar HIT-IgG(PF4-H), lot B38063 — safety notice
Recall expanded to lotB38063: negative bias can yield false-negative HIT-IgG results, delay HIT diagnosis and prolong heparin exposure. Stop use/destroy remaining stock, identify an alternative assay and assess prior results according to clinical risk.
41. Atellica CH Apolipoprotein B, lot252670 — safety notice
Increased imprecision at ApoB≤75mg/dL; maximum study CV15.1% at30–75mg/dL. Stop use/destroy lot252670 and assess the need to review prior patient results with clinical leadership.
Anvisa — Brazil
42. Keytruda (pembrolizumab100mg/4mL) — identified falsified lots
Anvisa reported falsified lots Z005197; Z012354, identified by discrepancies from the original packaging/product. Seizure and restrictions apply to the identified falsified lots; no portfolio-wide inference is made.
43. Dysport (botulinum toxin) — identified falsified lots
Anvisa reported falsified lots 025155, identified by discrepancies from the original packaging/product. Seizure and restrictions apply to the identified falsified lots; no portfolio-wide inference is made.
NMPA / CDR — China
44. Draft AE reporting guideline for implantable brain–computer interface hand-function systems
Draft AE-reporting guidance covers serious harm, hazardous failures, essential-performance loss, recurrent faults, misuse/compatibility/MRI, and all AEs of innovative devices during the first registration cycle. Existing reporting timelines apply. Consultation until 16 Nov2026; not final new obligations.