Two medicine safety updates — 27 August 2026

PharmExpert’s daily review of official pharmacovigilance sources identified one new medicine-safety update and one corrective recall notice.

Russia: MIOREOL® (donepezil + memantine) — QTc prolongation and torsade de pointes

Roszdravnadzor published Information Letter No. 01I-987/26 on 26 August 2026 (document dated 25 August 2026) concerning changes to the product information for MIOREOL®.

The updated information for donepezil adds reports of QTc interval prolongation and ventricular tachycardia of the torsade de pointes type, including in overdose. Cholinesterase inhibitors should be used with caution in patients with prolonged QTc, concomitant medicines that affect QTc, pre-existing cardiac rhythm disorders or electrolyte disturbances.

Official Roszdravnadzor notice · Official PDF

United States: Baxter anticoagulant sodium citrate solution recall

FDA published Baxter’s nationwide recall of one lot of Anticoagulant Sodium Citrate Solution USP 250 mL (product code 2B7867Q; lot Y493475; expiry 31 December 2027; NDC 0338-9669-01) because of possible fibreglass particles.

Potential consequences include vein irritation, inflammatory or hypersensitivity reactions and systemic embolisation with tissue or organ injury. Users were instructed to stop using affected units and return them. No adverse events had been reported when the notice was issued.

Official FDA recall notice

Why this matters

The Roszdravnadzor update introduces a clinically relevant cardiac-risk warning for donepezil-containing therapy. The Baxter action addresses a particulate-contamination risk requiring immediate stock identification and return.

This summary is based on official regulator publications and does not replace the approved product information or local clinical guidance.