Four medicine safety updates — 3 September 2026
- 03-09-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
Regulators in the United Kingdom, New Zealand, China and Spain have published four clinically important medicine-safety updates. The measures concern filtration during parenteral nutrition, major prescribing and product-information changes, prescription-only control of dextromethorphan–guaifenesin combinations, and the withdrawal of 22 illegal slimming products.
United Kingdom: filters required for parenteral nutrition
MHRA Device Safety Information DSI/2026/011 advises that all parenteral nutrition solutions should be administered through a filter with a pore size no larger than 1.2 µm. A 0.2 µm filter is good practice for aqueous, lipid-free solutions. The alert follows adverse incidents, including an embolism with a fatal outcome. Filters and administration sets should be changed with each new nutrition container in accordance with product shelf-life, infection-control policies and filter shelf-life.
New Zealand: September Prescriber Update
Medsafe’s Prescriber Update 47(3) highlights liver injury with CFTR modulators, including cases of liver failure requiring transplantation, and recommends monitoring transaminases and bilirubin. Other topics include rosuvastatin dose selection after a serious toxicity case, prednisone-induced thyrotoxic periodic paralysis, ocular effects of ADHD stimulants and alpha-gal-related hypersensitivity to biological medicines.
The bulletin also records important data-sheet changes, including tirzepatide and NAION, semaglutide and gastroparesis, inclisiran and serious hypersensitivity, glofitamab and PML, fingolimod and PML-IRIS, clobazam and DRESS, doxycycline and severe cutaneous reactions, and tranexamic acid and renal cortical necrosis.
Official Medsafe bulletin (PDF)
China: dextromethorphan–guaifenesin combinations become prescription medicines
NMPA Announcement No. 83/2026 converts seven dosage forms containing dextromethorphan hydrobromide and guaifenesin from OTC to prescription-only status. Revised product information adds post-marketing reactions, including neurological, gastrointestinal, allergic, psychiatric and cardiovascular effects, and strengthens contraindications, interaction warnings, overdose information and precautions related to respiratory disease, pregnancy, psychiatric conditions, hepatic or renal impairment and CYP2D6 variability.
Spain: 22 slimming products withdrawn
AEMPS has prohibited the sale and ordered the withdrawal of 22 slimming products containing undeclared sibutramine. Sibutramine may increase heart rate and blood pressure and has been associated with arrhythmias, ischaemic heart disease and serious vascular events. Seven products also contained undeclared phenolphthalein, which may cause fluid, electrolyte and protein loss, hypocalcaemia and malabsorption.