Medicine and device safety updates: 26 October 2026
Twenty topic groups from nine regulators cover recalls, product-information changes, assessment outcomes and pharmacovigilance procedures. This review covers official materials published or changed since the previous review. Publication and underlying decision dates are distinguished; a historical assessment does not establish a new safety signal.
For QPPV, LQPPV, LCPPV and pharmacovigilance professionals. Practical applicability depends on local requirements; role names and responsibilities can differ between jurisdictions.
Kyrgyzstan DLSMI
Desogestrel: product information changes on meningioma risk
DLSMI requires desogestrel marketing authorisation holders to update the SmPC and leaflet within 120 calendar days. Its 21 October letter adds current or previous meningioma as a contraindication, symptom monitoring and discontinuation if meningioma is diagnosed. Meningioma is added as an adverse reaction of unknown frequency; the benefit-risk balance remains favourable subject to these changes.
HPRA
Rifampicin: potential genotoxicity and contraception
The HPRA-agreed letter covers Rifadin, Rifinah and Rifater. Nonclinical potential genotoxicity supports advice for men with partners of reproductive potential to use a condom plus an additional method that together are highly effective during treatment and for three months afterwards. Women of childbearing potential should use highly effective non-hormonal contraception during treatment and for six months afterwards, with pregnancy testing before treatment. This is not evidence of an established clinical carcinogenic effect.
FDA
Ultimate Forza: recall for undeclared drug ingredients
In a company announcement posted by FDA, Tonight We Ride, LLC recalls all lots of Ultimate Forza Male Supplement containing undeclared sildenafil, tadalafil and dapoxetine. The notice identifies dangerous hypotension with nitrates. It covers item 810208/UPC 868592000002 and item 810222/UPC 868592000040 sold through certain GNC franchise locations, excluding GNC corporate stores. Consumers should stop use. No adverse events or complaints had been reported at the announcement date.
ANSM
Nextech Medical: closure-cap recall for sterility risk
ANSM reports a recall of universal closure caps SHHMP-0018-PE and SHHMP-0018, lot 20250920. Nextech Medical’s 20 October letter links defective individual-pouch seals to possible loss of sterility and patient infection risk. Users should stop use immediately, quarantine remaining stock and retain it pending return instructions, rather than destroy it on site.
LabPro: antimicrobial susceptibility reporting errors
ANSM publishes Beckman Coulter’s corrective action for LabPro V5.0. Software algorithm errors can affect vancomycin, daptomycin and clindamycin results for Gram-positive bacteria on specified MicroScan systems, potentially causing treatment failure or unnecessary antibiotic changes. The 12 October letter requires manual verification using its test/instrument/panel table, review of previous results and a software correction. Manual reading methods are unaffected.
GE HealthCare: revised patient-identity checks after image migration
ANSM’s update replaces earlier GE HealthCare instructions on patient/study misassociation after historical-image migration. Identity must be checked using identifiers permanently embedded in the image, rather than switchable overlays. Anatomy and implants are secondary checks only after identity is established. If identity cannot be confirmed reliably, affected images must not be used for interpretation or reporting. New inbound DICOM migration projects require prior consultation with GE HealthCare.
Ukraine SEC
Ukraine SEC: 2025 pharmacovigilance-system audit results
SEC reports 30 targeted PV-system audits in 2025: 11 in Ukraine and 19 abroad. It identified 120 findings: 16 critical, 86 major and 18 minor. These are findings, not company counts. Eleven of 68 CAPA-plan versions and 12 of 21 implementation reports were agreed. Further regulatory responses are being assessed for nine of 14 applicants that did not remedy critical and major findings in time; the report does not say sanctions have already been imposed.
ANVISA
Assessment of antimicrobial stewardship programmes
ANVISA launches its 2026 national assessment of hospital antimicrobial stewardship programmes, with participation until 20 December 2026. The communication links stewardship to safe and rational use, adverse-event prevention and reduced resistance. This is a safety-system initiative rather than a new product-specific signal.
TGA
LANA KIT Tobacco Pod: single-batch diacetyl recall
TGA’s database records a Class II retail recall of LANA KIT Tobacco Pod 20 mg/mL, 2 mL, batch LN07820251126007, expiry 31 December 2027. Testing detected diacetyl at 3.8 µg/mL; repeated inhalation is associated with lung-disease risk. Retailers should quarantine affected stock and return it according to the customer letter. No adverse events were reported; other batches and Better Health International products are unaffected.
TFE3 (MRQ-37): reagent recall for weak or absent staining
TGA records a Class III hospital recall of TFE3 (MRQ-37) Rabbit Monoclonal Antibody, 0.1 mL concentrate, code 354R-14, lot 0000559553. Stability testing found possible weak or absent staining before expiry, potentially causing inconclusive, false-negative or incorrect results. Customers should identify and destroy affected stock under local procedures; replacement or credit is offered.
Health Canada
Unauthorized peptides: new health-risk information
Health Canada’s new section addresses unauthorized peptides, covering risks from the substance, injection, contamination and incorrect composition. Testing of seized products found examples lacking the advertised peptides and products that were not sterile. A research-use label does not demonstrate safety for human use. The communication concerns unauthorized products and is not a class-wide warning about authorized peptide medicines.
Canada Vigilance: monthly database update
MedEffect Canada announces a 23 October update to Canada Vigilance. The database page states that it covers data from 1965 through 30 June 2026. This is a pharmacovigilance resource: suspected-reaction reports alone do not establish causality or provide a conclusive safety assessment.
EMA
PRAC minutes for 31 August–3 September published
Published on 23 October, the minutes cover the 31 August–3 September meeting. They document further-review requests on accidental fentanyl-patch exposure, idarucizumab/disseminated intravascular coagulation, TNF-inhibitor/IgA nephropathy and progestogen/meningioma signals; these remain evaluations rather than established new reactions. Label recommendations include oxacillin/DRESS, belzutifan/retinal oedema, daridorexant and ivacaftor warnings, lenalidomide/HLH and PML, and alendronate/atypical fractures. PASS assessments and follow-up obligations are also recorded. The minutes count as one newly published document, without recounting earlier decisions as new 26 October signals.
Diacerein: nausea and vomiting added to product information
EMA publishes a PSUSA outcome requiring variation: CMDh agrees that nausea and vomiting should be added to the SmPC and leaflet with unknown frequency. A causal relationship is considered at least reasonably possible based on spontaneous reports and literature. The position was adopted in September, with translations due by 1 November and MAH variation submissions by 31 December 2026. The benefit-risk balance remains unchanged subject to the update.
Voriconazole Hikma: contraindication and interaction alignment
Updated Voriconazole Hikma documents align with reference medicine Vfend by adding contraindications for concomitant eplerenone and voclosporin and interaction information for mavacamten. The procedure records an opinion on 6 October and a decision on 22 October, with publication on 23 October. A separate secondary-packaging-site change is not counted as a PV signal.
Silapo: safety information and traceability alignment
The 23 October Silapo procedure adds polysorbate 20 information and aligns safety, traceability, pregnancy, breastfeeding and fertility wording with reference medicine Eprex/Erypo. The SmPC, labelling, leaflet and Annex II are updated. This is biosimilar safety-information alignment rather than a newly confirmed signal.
Prolia: injection-site reaction update published
Prolia’s documents are updated on 23 October. Procedure EMA/VR/0000326998 adds injection-site reactions as an uncommon adverse reaction and includes polysorbate information. The opinion was issued on 23 April and the decision on 11 September. The history also records RMP 33.1 and osteonecrosis-of-the-jaw reminder-card updates. The publication date does not represent a new October safety decision.
Leqvio: two paediatric study assessments published
EMA publishes two Article 46 assessments: ORION-16 in adolescents with heterozygous and ORION-13 with homozygous familial hypercholesterolaemia. The reports identify no new or unexpected signals; ORION-13’s 13 participants provide insufficient data for definite safety conclusions. Pharmacokinetic and immunogenicity questions were referred to the related variation. These are newly published assessments of earlier studies, not a separate new authorisation or label change on 23 October.
Trixeo Aerosphere: safety assessment for expanded use
The newly published package includes Trixeo Aerosphere’s extension assessment, RMP and product information. The final indication covers maintenance treatment of asthma from age 12 when medium-dose inhaled corticosteroid plus a long-acting β2 agonist provides inadequate control. No new major safety signals were identified; limited direct adolescent data and uncertainty beyond one year require PSUR monitoring. The final indication should be distinguished from the broader initial application.
Bundibugyo vaccines: safety-monitoring requirements
AMA and EMA set requirements for accelerated clinical development of Bundibugyo vaccines. Safety remains the primary early-trial endpoint: solicited events are collected for seven days, unsolicited events for one month, and serious events and AESIs for six months after the last dose. Paediatric progression requires predefined stopping rules and independent oversight. Reliance on established platform data does not remove participant safeguards or regulatory agreement.