Medicine and device safety: review as of 16 October 2026

A review of official medicine and device safety communications and pharmacovigilance procedures. A new publication date does not necessarily coincide with the decision date or discovery of a risk. Sources and document dates are identified below.

The review may help QPPV, LQPPV and LCPPV assess relevance to their products, local obligations, product information and risk-minimisation measures. These role names and responsibilities are not assumed to be identical across jurisdictions.

Antidepressants: communicating known risks

MHRA describes a boxed warning in the patient leaflet, a patient card and the term PSSD for specified antidepressants. An additional safety leaflet is expected in 2027. These measures communicate known risks, including suicidal thoughts/behaviour and persistent sexual dysfunction; patients should not stop treatment without consulting a healthcare professional.

Document/action date: 15 October 2026. MHRA · DSU vol20 issue3 October2026:1

Levofloxacin: encephalopathy

Ukraine’s SEC published recommendations to update oral and intravenous levofloxacin information for encephalopathy. The 15 October publication refers to PRAC’s 8–11 June meeting. The attached Ukrainian register list is current to 2 October and is not a list of separate safety signals.

Document/action date: 8–11 June 2026. Ukraine SEC · PRAC 8–11 June 2026; PSUSA/00010767/202310

Opuviz / aflibercept: retinal vasculitis

EMA’s scientific conclusions, dated 23 July and published on 15 October, identify at least a reasonable possibility of a causal relationship between aflibercept and retinal vasculitis with or without occlusion. Product information for ophthalmological formulations should change; the benefit–risk balance remains unchanged subject to those changes.

Document/action date: 23 July 2026. EMA · PSUSA/00010020/202511; EMADOC-1700519818-3486486

Koselugo: revised ocular safety information

Procedure EMA/VR/0000347385 revises ocular safety information and time to onset of the maximum CTCAE grade of left ventricular ejection fraction reduction in KOMET. RMP 5.2 reclassifies central serous retinopathy (CSR) and retinal pigment epithelial detachment (RPED) as non-important identified risks; retinal vein occlusion remains an important potential risk. This reclassification does not change the existing risk-minimisation measures in SmPC sections 4.2/4.4.

Document/action date: 3 September 2026. EMA · EMA/VR/0000347385

Herbal medicine interactions: draft guidance

EMA opened consultation on draft EMA/HMPC/362638/2025 concerning investigation of herbal medicine interactions, including literature, post-marketing evidence and preparation-specific considerations. Consultation closes on 15 January 2027. This is draft guidance.

Document/action date: 24 September 2026. EMA · EMA/HMPC/362638/2025

Hydroxyethyl starch: PSUSA outcome

PSUSA/00001694/202603 records a Maintenance outcome. This alone does not establish removal of earlier restrictions or a newly identified risk.

Document/action date: Not stated on the card. EMA · PSUSA/00001694/202603

Rifadin: timetable for the ongoing review

The 15 October Rev.1 timetable schedules responses in January and possible further questions or a CHMP opinion in February 2027. The review concerns diethanolamine in rifampicin 20 mg/ml oral suspension/syrup. The timetable does not itself establish a new benefit–risk conclusion.

Document/action date: 15 October 2026. EMA · EMA/REF/0000355053;EMADOC-1700519818-3224382 Rev1

Ratiograstim / Tevagrastim: arteritis

Shared procedure EMA/VR/0000367842 aligns information with Neupogen: the warning now covers large and medium vessel arteritis, including aortitis, adds headache and neck pain, and lists arteritis as a rare adverse reaction. Sorbitol information is also updated.

Document/action date: 15 October 2026. EMA · VR/0000367842 · EMA · VR/0000367842

Elaprase: excipient information

EMA/VR/0000373474 adds polysorbate 20 information and an allergic-reaction warning: 0.726 mg per vial, equivalent to 0.22 mg/ml. Sodium wording is also revised. The administrative part of the procedure is not a separate new safety signal.

Document/action date: 15 October 2026. EMA · VR/0000373474

Canada: cobas c303

Health Canada describes deterioration of a rinse tube; rupture and leakage may produce erroneous analytical results. Small pinholes alone have no analytical impact. Consult RA-82785 for the affected unit and official instructions.

Card publication date: 15 October 2026. Health Canada · RA-82785

Canada: HemosIL AcuStar HIT-IgG(PF4-H)

RA-82787 concerns lot B38062, catalogue number 0009800127, with negative result bias and possible calibration failures.

Document/action date: 29 September 2026. Health Canada · RA-82787

Canada: EMIT2000 Quinidine Assay

RA-82788 describes increased variability in lots 2597, 2709 and 2627, OSR4Q229, affecting claimed repeatability and within-laboratory precision.

Document/action date: 21 September 2026. Health Canada · RA-82788

Canada: Cochlear CI1012

RA-82797 identifies possible open circuits on individual electrodes for the specified CI1012, model P1979576, serial number 1020210125031.

Document/action date: 5 October 2026. Health Canada · RA-82797

France: Philips ICCA

ICCA J.06.01/J.06.02 can calculate fluid balance incorrectly under specified automatic infusion-charting settings, affecting clinical decisions. FSN 2026-CC-HPM-006 provides interim configuration measures; J.06.03 corrects the problem.

Document/action date: September 2026. ANSM · R2626323;2026-CC-HPM-006;FCO86300087

France: ORTHO Sera Anti-Fyb

FSN 00002-2026 concerns false-positive Fy(b-) results in lots V283670 and V279053, ref. 6904487. Stop use, dispose of affected stock and review prior results. Longer-term alloimmunisation/subsequent haemolysis requires additional conditions; false-positive donor typing alone does not imply an incompatible transfusion.

Document/action date: 28 September 2026. ANSM · R2629538;FSN00002-2026

France: Unity ASC

FA-2026-005 Rev.01 concerns handle ref. 1232040, lot 097921: failure of the locking-pin weld may delay surgery. Quarantine and return are required. No cases of a pin being lost or retained in the joint have been reported.

Document/action date: 15 October 2026. ANSM · R2628774;FA-2026-005 rev01

Brazil: ivermectin and cancer treatment

ANVISA warns that ivermectin has no proven efficacy against cancer. Replacing established oncology treatment may reduce the chance of cure or disease control; unsupervised use adds interaction and adverse-reaction risks.

Document/action date: 15 October 2026. ANVISA · Official communication dated 15 October 2026

Brazil: transitional inspections of blood services

ANVISA’s 15 October communication and Note 75/2026 explain the transitional inspection guide, including haemovigilance, alongside RDC 34/2014. Portaria GM/MS 11685 has applied since 30 September. The MARP-SH statistical calculation is unchanged; the announcement is not a new law dated 15 October.

Communication date: 15 October 2026; technical note signed on 14 October 2026. ANVISA · NotaTecnica75/2026/SEI/GSTCO/GGBIO/DIRE2/ANVISA;SEI4516972

Brazil: RE4.035 — unregistered products

RE4.035, dated 9 October and published on 14 October, contains six separate entries concerning unregistered products. The scope of action differs between entries; a uniform ban must not be inferred. In particular, the Liberty Pharma entry preserves an exception for personal imports by individuals for their own use. ANEXO specifies the products, responsible parties and actions.

Document/action date: 9 October 2026. ANVISA · RE 4.035 dated 9 October 2026; DOU 14 October, section 1

Australia: 6008 CAREsystem

Changing time during an active ultrafiltration profile in software 2.50/2.50.1 can stop the pump. The official card explains the risk of reduced treatment and interim steps; a software update is expected in Q2 2027.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00797-1

Australia: NCC74 corneal tissue

Interface fragments have been identified in some DSAEK grafts; no adverse patient outcomes have been reported. The tissue bank requests identification of recipients and the specified steps during routine follow-up.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00807-1

Australia: ELUCIREM labelling

Labels incorrectly state mg instead of g while the numerical quantities are correct. The manufacturer considers an effect on dosing unlikely; quality is unaffected and stock may be used according to the Product Information.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00754-1

Australia: three Andrographis actions

TGA describes recalls of Fusion Health VIRAFORCE, Immunity Boost Forte and MEDIX/COLES Cold & Flu Day & Night following continued reports of Andrographis-associated anaphylaxis. Each product has its own batches and return/destruction instructions. Affected products should not be used; these are three separate actions addressing a known risk.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00765-1 · TGA · RC-2026-RN-00818-1 · TGA · RC-2026-RN-00809-1

Australia: Libre App

The Libre App 1.4.0 vulnerability requires close physical proximity and cannot be activated remotely over the internet. Incorrect readings/alarms could affect treatment decisions. Update to 1.4.1 or later; sensors can remain in use. As of 9 October, no related unauthorised access or adverse events were known.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00826-1

Australia: LUISA, TIVAN LS, Life One

LM150TD firmware 1.15.0010/.0018 can allow unnoticed battery depletion and shutdown without warning. Consequences could be fatal for ventilation-dependent patients. Update to 1.15.0020+ and follow interim measures; no market incidents were reported.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00795-1

Australia: Olympus HF cables

The alert extends an earlier action to additional cable models. TGA reports 60 potentially related thermal complaints over 4 years, without serious injuries. Observe the 12-month service life and inspect cables before use.

Document/action date: 14 October 2026. TGA · RC-2026-RN-00814-1

Australia: Abre

An IFU update describes a validated manual workaround for partial stent deployment. As of 14 September, 31 cases were reported; 4 required further intervention. Retrieval or disposal is not requested.

Document/action date: 13 October 2026. TGA · RC-2026-RN-00816-1

Australia: da Vinci grip cables

This follow-up to a 2025 recall addresses frayed/broken cables, loss of grip and potential tungsten particles. Check product codes, versions and batches against the official list and return affected instruments.

Document/action date: 13 October 2026. TGA · RC-2026-RN-00801-1