Medicine and device safety updates: 27–28 October 2026
- 28-10-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
This review for 27–28 October 2026 brings together official medicine and device safety materials: product-information changes, risk-minimisation measures, recalls, assessment outcomes and professional materials. Source-document dates are shown separately; the review also includes additional official materials with 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.
Roszdravnadzor
Xelticin: updated risk-minimisation materials
The patient card and 17-page prescriber guide for 5 mg and 10 mg tablets address infections, malignancy, cardiovascular and thrombotic risks. The card should be retained for at least two months after the last dose. This is an update to additional risk-minimisation materials.
Eculeris: prescriber and patient safety materials
The letter provides prescriber and patient brochures and a patient card. Measures include meningococcal vaccination at least two weeks before treatment and antibiotic prophylaxis in the situations specified in the materials. Vaccination does not remove the need to monitor for infection.
Citramon P: affected consignment withdrawn
Roszdravnadzor stopped circulation of the identified consignment of batch 320725 because it failed requirements for description and related impurities (salicylic acid). The letter requires withdrawal and destruction of that consignment and measures to address the threat to life and health. The action is limited to the identified consignment.
ASK-cardio100 mg,100 tablets: affected consignment withdrawn
Roszdravnadzor stopped circulation of the identified consignment of batch 050060225 because it failed requirements for labelling. The letter requires withdrawal and destruction of that consignment and measures to address the threat to life and health. The action is limited to the identified consignment.
Ukraine SEC
Diacerein: Ukrainian product-information update
Ukraine SEC calls for nausea and vomiting, frequency not known, to be added to diacerein product information following PRAC/CMDh assessment of spontaneous reports and literature. The benefit-risk balance remains unchanged subject to these amendments.
EMA
PRAC
For encorafenib with binimetinib, PRAC recommends adding neutropenia as a common adverse reaction, with a variation due within two months of publication. Although the signal heading also mentions febrile neutropenia, the added wording is neutropenia. Further assessments are requested for cisplatin, elranatamab, liraglutide, semaglutide and tarlatamab; dapagliflozin and ixekizumab remain subject to pharmacovigilance follow-up. These assessment requests do not establish new causal relationships.
PRAC agenda
EMA published the 55-page draft agenda for the 26–29 October meeting, covering ongoing safety procedures, signals and risk-management plans. A draft agenda is not a final committee decision.
Idacio: final RABBIT safety-registry report
The procedure history records submission of the final observational RABBIT registry report, a category 3 study in the risk-management plan, and RMP version 8.2. This is post-authorisation safety-assessment documentation.
Vocabria: pregnancy information update
Sections 4.6 and 5.2 were updated using interim HPTN084/084-01 results. Use during pregnancy is permitted when the expected benefit justifies the potential fetal risk, without dose adjustment. As Vocabria is used with rilpivirine to treat HIV-1, rilpivirine pregnancy information must also be considered.
Glivec: DFSP starting dose
For dermatofibrosarcoma protuberans, the starting dose changed from 800 to 400 mg/day following evidence of similar efficacy and improved tolerability. An increase to 800 mg/day may be considered for insufficient response in the absence of adverse reactions. The opinion is dated 17 September and Commission decision 19 October.
Semglee: pre-filled pen illustrations
The leaflet adds pre-filled pen images and knob-colour descriptions as part of a device change. This is a use-information update rather than a newly identified adverse reaction.
Pyzchiva: product-information and RMP alignment
Product information was aligned with the reference medicine for ulcerative colitis; paediatric information was also aligned except for the indication section. The RMP was updated. Approved age limits and formulation-specific information remain applicable.
Lynavoy: initial risk-management plan
The initial linerixibat document package concerns cholestatic pruritus in adults with primary biliary cholangitis. The medicine is subject to additional monitoring. Its RMP includes the LLSAT212358 long-term safety study, with the final report due in March 2027.
Wegovy: hepatic-impairment information
Sections 4.2, 4.4, 5.1 and 5.2 address hepatic impairment and MASH. The product information states that no dose adjustment is required in mild or moderate impairment and experience in severe impairment is limited. Use is not recommended in moderate or severe hepatic impairment with MASH; caution is required with any hepatic impairment. The pharmacokinetic rationale does not override these restrictions.
Hemlibra: published assessment report
The HAVEN5 assessment confirms consistency with the established emicizumab safety profile and no change in its benefit-risk balance. Publication of the report does not represent a new signal.
Bavencio: published assessment report
The paediatric avelumab–lenvatinib study did not show a clear antitumour-activity signal and did not proceed to expansion. No new safety concerns were identified; no regulatory action or product-information update was required.
MHRA
Xeal Pharma liquid clopidogrel: Class 2 recall
A formulation error left affected solutions and suspensions with 76% of the labelled clopidogrel content. This patient-, pharmacy- and wholesaler-level recall covers all previously produced affected batches listed in the annex. MHRA calls for coordinated replacement and warns against sudden discontinuation; no patient-harm reports had been received.
MedSafetyWeek and Yellow Card improvements
The 2–8 November campaign promotes reporting suspected adverse reactions and incidents. MHRA describes Yellow Card website and app improvements, including NHS login integration. Suspicion is sufficient for reporting; treatment and reaction timing, concomitant medicines and follow-up information are valuable.
MHRA October safety roundup
The 27 October MHRA roundup addresses osimertinib skeletal-muscle toxicity, including overseas rhabdomyolysis reports, with no such UK Yellow Card reports at the time of the review. It also addresses venlafaxine and other SNRIs affecting ioflupane DATSCAN results, potentially causing false-positive findings and misdiagnosis. Temporary treatment interruption before imaging requires an individual assessment and must be safe and appropriate.
PMDA/MHLW
inclisiran sodium: revised precautions
Hypersensitivity, including anaphylaxis, angioedema and urticaria, is added to clinically significant adverse reactions following PMDA assessment of reports.
ibuprofen L-lysine: revised precautions
TEN and Stevens–Johnson syndrome are added for intravenous ibuprofen L-lysine. PMDA identified no reasonably possible causal cases for this formulation; the action aligns warnings with those already used for ibuprofen.
tacrolimus hydrate ointment: revised precautions
For the paediatric 0.03% ointment, the age contraindication changes from under two years to under six months. For children aged six months to under two years weighing under 10 kg, the maximum per application is 0.5 g. This follows paediatric-study assessment, not a new toxicity signal.
amenamevir: revised precautions
Anaphylaxis is added to clinically significant adverse reactions. PMDA reports 12 Japanese cases, four with reasonably possible causality, and no deaths.
PMDA: five ongoing risk evaluations
Ongoing evaluations concern contact dermatitis with tapinarof; thrombotic thrombocytopenic purpura with oral terbinafine; drug-induced hypersensitivity syndrome, rhabdomyolysis and myopathy with leflunomide; and acute coronary syndrome accompanying allergic reactions with midazolam and oxaliplatin. These are evaluations, not confirmed new restrictions.
Health Canada
FreeStyle Libre3 App: safety notice
The security patch could cause prolonged sensor communication loss. Health Canada advises an immediate update to version 3.6.10.
Magnetom Free.Max / Magnetom systems: safety notice
Two notices describe service pack NX VA60A-SP04, including breast-biopsy image-loading fixes and predictable, safe table movement, alongside other corrections. The notices identify the affected models and serial numbers.
Echo Wireless Fetal Doppler with Earphones: safety notice
The instructions for B0113, lots BBL-479 and BBL-429, are clarified because wording caused confusion about the intended use, to support safe and proper use.
Abre Venous Self-Expanding Stent System: safety notice
The instructions add a validated manual-deployment workaround for rare partial stent deployment, intended to reduce potential harm. No product retrieval or disposal is requested.
DxC500i / DxC500AU: safety notice
In versions 1.5 and earlier, operator changes to 25 predefined calculation rules may revert to default expressions after a parameter-package or software upgrade. The official notice identifies the affected modules.
TGA
Euroimmun IIFT Legionella Mosaic7: market action
Lot T260619BM (FI2150-1010-7P) is recalled for reduced reactivity and nonspecific fluorescence, with possible false-negative, incorrect or inconclusive results. Remaining stock should be quarantined and returned.
KLS Martin Uterine Curettes: market action
IFU revision 04 adds a warning on intrauterine adhesions and Asherman syndrome after intrauterine surgical procedures. Users should review the updated instructions.
Access HIV Ag/Ab Combo Calibrator: market action
Reversed calibrator assignments in the 2D barcode may cause false reactive or nonreactive results. TGA identifies eight lots and calls for discontinuing affected calibrators and retrospective result review. Testing may resume with calibrator lot 672285 or higher.
Cisplatin50mg Freeflex / Slade Health: market action
A leak was detected before patient treatment in compounded batch BB26081712, expiry 03 October 2026. The action is limited to that batch; other cisplatin batches and Slade Health products are unaffected.
ANSM
CREP2 Roche Diagnostics: safety notice
ANSM reports falsely high creatinine results, predominantly in patients with monoclonal gammopathy. For the identified CREP2 lots, it recommends stopping use and quarantine where an alternative exists, and verification of doubtful results by another method when no alternative is available.
Asclepios3 Alma: safety notice
In versions 3.11.03 and earlier, a particular Back-button sequence can mix two patients’ information on the prescription screen and calculate a dose from the wrong patient data. The notice recommends menu navigation instead of Back until correction. It plans version 3.11.04; it does not establish actual release.
Philips dual invasive-pressure adapter989803199741: safety notice
With two non-defibrillation-protected probes connected simultaneously, protection may be lost, creating risks of insufficient defibrillation energy, delayed monitor recovery and electric shock to the user. Compatible probes and accessories should be used as specified in the manual.
Promecon KRYSTAL camera drape AC372: safety notice
Lots 12340 and 12624 are recalled for image blur or distortion that could delay or interrupt an endoscopic procedure. This is an optical defect; the notice does not establish a sterility failure.
Beldico milk-collection sets: safety notice
A moulding defect prevents suction, making the sets unusable for milk collection. The recall covers HPF13071G lots 26G06/26G13 and HPF13071 lot 26F15, for return by 30 November. The manufacturer states that there is no major health risk to mother or baby.
Atellica CH/CI reagents HDLC and TP_2: safety notice
HDLC carryover may falsely elevate A1c on Atellica CH and CI; TP_2 carryover may falsely lower DBil_2 on CI only. Actions include Clean2 probe washing and software/test-definition updates, with medical review of the need to check previous results.
FreeStyle Libre3 and Libre: corrected app update
ANSM advises an immediate update to corrected app versions that address both the vulnerability and prolonged signal loss. The 27 October instruction replaces the 19 and 22 October instructions, including the temporary advice to defer updating.
AEMPS
Enerup Premium: withdrawal for undeclared sildenafil
AEMPS ordered cessation of sale and withdrawal of Enerup Premium after laboratory confirmation of undeclared sildenafil. The agency highlights contraindications, interactions and potentially serious cardiovascular adverse reactions. The finding concerns the named product.
Anvisa
Tegretol: clarification of an existing neonatal restriction
The letter clarifies that the neonatal contraindication due to propylene glycol has been in the Brazilian label since October 2024 and applies only to the 20 mg/mL, 100 mL oral suspension. It does not change tablet dosing or recommendations for other patient populations.
Kazakhstan NDDA
Kazakhstan: pharmacovigilance monitoring methods
The congress discussion addressed pharmacovigilance data quality, analytical methods and AI-supported work subject to expert validation. The article describes professional proposals and discussion, not newly adopted binding requirements.
China CDR
CDR: nine device adverse-event terminology drafts
CDR opened consultation until 15 November 2026 on nine device adverse-event terminology drafts. They concern the classification of device problems, harm and components, and are not reports of new faults in specific products.
Medsafe
Philips Allura Xper FD: display-fault correction
A FlexVision software fault can cause a blank or frozen display during clinical use. A cold restart restores functionality; a software upgrade is planned.
Philips Lumify: software correction
An incorrect transducer re-registration request requires network access, while an unstable USB connection can interrupt scanning. Both may delay patient care; a software upgrade is planned.
i-STAT hs-TnI cartridges: interference advice
Lots beginning A24,A25,B25,B26,C26 and D26 may have reduced protection against certain analytical interferences, causing falsely high troponin I. There is no evidence of falsely low results. The manufacturer provides use advice.
Intuitive Surgical reusable instruments: affected-product recall
Partial or complete grip-cable failure may cause loss of grip, exposed frayed cable or tungsten particulate. The action calls for return of affected instruments.