Medicine and device safety: 30 October–2 November 2026
- 02-11-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Thirteen official communications from seven regulatory sources cover safety reviews, revised warnings, prescribing systems, diagnostic devices and pharmacovigilance education. These communications do not represent thirteen new safety signals.
PRAC: Deanxit review and immunoglobulin safety signal
EMA · 2026-10-30
EMA reports reviews of persistent neurological/psychiatric reactions with Deanxit and increased hypersensitivity reporting for particular immunoglobulin batches. Neither review is a final regulatory conclusion. The Deanxit procedure began on 16 October; this communication was published on 30 October.
Ritlecitinib: revised risk-minimisation warnings
State Expert Center, Ukraine · 2026-10-30
SEC describes updates to warnings on serious infections, malignancy, cardiovascular events and thrombosis. In specified higher-risk patients, ritlecitinib should be used only when suitable alternatives are unavailable. This is a Ukrainian communication of earlier PRAC/CHMP conclusions.
Alendronate: atypical fractures beyond the femur
State Expert Center, Ukraine · 2026-10-30
SEC communicates warnings and adverse-reaction wording for atypical fractures in other bones, including the ulna and tibia. For suspected cases, interruption during assessment is considered against individual benefit and risk; reported frequency is unknown.
Ocrevus: drug-induced liver injury monitoring
State Expert Center, Ukraine · 2026-10-30
SEC publishes a DHPC template describing drug-induced liver injury, including severe cases. Liver tests are recommended before treatment and before the second initial 300 mg infusion. Confirmed liver injury requires treatment cessation; treatment should not be restarted unless a plausible alternative cause is established. The card date is not a completed local DHPC issue date.
Lenalidomide: HLH warning and rare PML
State Expert Center, Ukraine · 2026-10-30
SEC communicates a haemophagocytic lymphohistiocytosis warning and progressive multifocal leukoencephalopathy as a rare adverse reaction. Marketing authorisation holders are asked to monitor and document relevant cases. The underlying PRAC meeting was held in August–September, not on the card date.
NETSoins: missing dosing-interval alerts
ANSM · 2026-10-30
The 22 October manufacturer notice describes missing alerts for medicines taken less often than daily, including methotrexate. Users should check the recommended interval in the monograph; the corrective release was planned for early November.
ORBIS Medication: duplicated one-time prescriptions
ANSM · 2026-10-30
The 22 October notice describes duplication of a one-time prescription into the default daily regimen, creating unnecessary administration tasks. Prescribers must check the duplicated schedule and install the correction when available; affected versions and rollout dates vary by jurisdiction.
ERY Q KKD/MNS: blood-group genotyping correction
ANSM · 2026-10-30
The 14 October notice concerns incorrect interpretation of a rare GYPB genotype in PlexTyper. Updated kit files and reassessment of affected results are required. The manufacturer describes a very low haemolytic transfusion-reaction risk in the specified failure scenario.
Philips Azurion: non-specified SSDs
ANSM · 2026-10-30
The October notice describes possible loss of imaging, motorised movement or data after installation of non-specified SSDs during service. Philips plans inspection and replacement. No related injuries had been reported; the notice describes potentially serious consequences, with an estimated unlikely probability.
PEDMARQSI: vial inspection and in-line filtration
HPRA · 2026-10-30
The 28 October DHPC requires vial inspection and an appropriate in-line filter. Particles can cause embolic, thrombotic or infusion-site reactions; none suggesting these risks had been reported. Sterility is unaffected and no new safety signal was identified. Filtration does not replace inspection.
November product-information safety update
Swissmedic · November 2026 table; reviewed 2 November 2026
The monthly table covers aflibercept ocular precautions; alectinib hypertriglyceridaemia/pancreatitis; dabrafenib/trametinib radiation injury; galantamine nightmares; GLP-1 agonists necrotising pancreatitis; antiandrogens cytopenias; olmesartan enteropathy; peanut-allergen precautions; SGLT2 inhibitors Fournier’s gangrene; and velmanase alfa infusion reactions. These are information updates, not eleven new signals.
Reporting suspected side effects
HSA · 2026-11-02
HSA explains how patients can discuss suspected side effects with healthcare professionals and how reports support safety monitoring. This is pharmacovigilance education, without a new product-specific signal.
Estradiol shortages: safety-based selection of alternatives
AEMPS · 2026-10-30
AEMPS advises individual assessment of estrogen formulation, route and dose during shortages. Temporary prioritisation of transdermal treatment may be appropriate when oral formulations are clinically unsuitable because of relevant risk factors. These are safety-related prescribing recommendations, not a new adverse-reaction signal.
Professional relevance
For QPPV, LQPPV and LCPPV, these communications may inform local applicability reviews, product-information reconciliation and risk-minimisation follow-up. Role names and duties differ across jurisdictions.