Pharmacovigilance and regulatory safety updates — 14 October 2026

This monitoring update summarises official safety materials relevant to QPPV, LQPPV and LCPPV functions; titles and responsibilities may differ by jurisdiction.

Official safety updates

• Roszdravnadzor, 13 October: recall of Methylenum blue 1% 25 ml, batch 030226, after a microbiological-purity nonconformity. Official source
• TGA, 14 October: administering only liquid/diluent without reconstituting the powder component can cause suboptimal protection and re-vaccination. Official source
• TGA DRAC: Immunitone Plus and Phytologic immune products: Andrographis/anaphylaxis; Swisse Beauty Skin Regeneration+: lead action with a regulator-stated non-clinically-meaningful modelled blood-lead increase. Immunitone Swisse Phytologic
• Lareb, 13 October: atrial-fibrillation risk with high-dose omega-3, particularly with CV risk; no established relation for low-dose/food omega-3. Official source
• Swissmedic, 12 October: neuroleptic-malignant-syndrome communication associated with antipsychotic treatment. Official source
• ANVISA, 13 October: Ortho Sera Anti-Fyb lots V283670 and V279053: remove, destroy and review prior testing. Official source

EMA updates

• Fingolimod Accord: SCC frequency rare to uncommon.
• Qalsody: correction to MRI findings in serious myelitis cases.
• Rinvoq, Bemfola and Intuniv: updated safety/effectiveness or administration information.
• Revision 14 of EMA acceptable-intake guidance for N-nitrosamines.

Fingolimod Accord | Qalsody | Rinvoq | Bemfola | Intuniv | N-nitrosamines guidance

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on official communications issued by Roszdravnadzor, TGA, Lareb, Swissmedic, ANVISA and EMA, current as of 14 October 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by any manufacturer/marketing authorisation holder or a quality concern affecting a company’s entire product portfolio. Company and product names are used only to identify the official material accurately. Decisions should be based on the primary source, the regulator’s instructions and the approved product information.