Four medicine safety updates: ciprofloxacin, noradrenaline, thiocolchicoside and undeclared PDE-5 inhibitors

Regulators published four high-importance medicine safety updates on 2 October 2026.

Health Canada: ciprofloxacin and SIADH

Health Canada found a possible link between systemic ciprofloxacin and syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Five cases were assessed; no deaths were reported. Canadian product monographs for systemic ciprofloxacin products will be updated.

Roszdravnadzor: NORADRENALIN AGETAN batch J1672A02

Roszdravnadzor reported that batch J1672A02 of NORADRENALIN AGETAN 2 mg/ml concentrate did not meet secondary-packaging labelling requirements. Supply-chain participants were instructed to take measures aimed at eliminating threats to life and health and to report the outcome.

Ukraine State Expert Center: KONTROLFLEX (thiocolchicoside)

Ukraine’s State Expert Center published an HCP communication on KONTROLFLEX (thiocolchicoside) and genotoxicity risk. The official card describes dose and duration limits and contraindications intended to reduce aneuploidy-related risks.

AEMPS: withdrawal of products with undeclared active substances

AEMPS ordered withdrawal and cessation of marketing of Etumax Royal Honey, Miel Soudan VIP, Epimedyumlu Macum and Organic Honey after undeclared sildenafil was detected. Etumax also contained tadalafil and Organic Honey contained paracetamol. AEMPS highlighted contraindications, interactions and potentially serious cardiovascular reactions.

These actions are relevant to QPPV, LQPPV and LPPV teams for signal and label surveillance, risk-minimisation follow-up, local impact assessment and product-quality escalation.

Official sources

• Health Canada
• Roszdravnadzor card and official PDF
• Ukraine SEC card and official index
• AEMPS

Disclaimer. This material is provided solely for information and pharmacovigilance purposes, based on the official communications issued by Health Canada, Roszdravnadzor, AEMPS and the State Expert Center of the Ministry of Health of Ukraine and current as of 5 October 2026. It is not medical or legal advice, does not replace the official sources, and does not imply wrongdoing by the manufacturer/marketing authorisation holder or a quality concern affecting any company’s entire product portfolio. Company and product names are used only to identify the official materials accurately. Decisions should be based on the primary sources, the regulators’ instructions and the approved product information.