Nine medicine safety updates — 18 August 2026

On 18 August 2026, PharmExpert identified nine significant medicine-safety materials issued by regulators in Russia, Ukraine, Australia, Canada, Ireland and Japan.

Key updates

1. Ipidacrine: benefit–risk review

Ukraine’s State Expert Center reported the start of an EMA review of ipidacrine medicines. The assessment concerns efficacy in authorised indications and a potential risk of liver injury. Official notice.

2. Melanotan II: inconsistent dosing

The TGA found approximately 22–54 mg in nasal sprays labelled as containing 30 mg. The regulator warns of an increased risk of adverse events and advises consumers to stop using these products. TGA safety alert.

3. Teva-Pregabalin 150 mg: sertraline cross-contamination

Canadian lots 100070495 and 100068913 were recalled because of possible cross-contamination with sertraline. Allergic patients may face anaphylaxis, which can be fatal. Health Canada notice.

4. Lactated Ringer’s Injection: particulate matter

Health Canada announced the recall of lot J4H077 due to particulate matter in an infusion solution, a clinically important quality defect for a parenteral product. Recall notice.

5. Warfant 3 mg: 1 mg tablets found in a sealed pack

The HPRA announced a patient-level recall of batch 25002. The warfarin strength mix-up may result in inadequate anticoagulation. Patients are asked to check packs and contact their prescriber if an incorrect dose was taken. HPRA safety notice.

6. Donanemab and lecanemab: APOE testing and ARIA risk

PMDA/MHLW revised precautions to recommend considering APOE testing before treatment, explaining the test and its implications to patients, and continuing MRI monitoring regardless of genotype. The measure aims to improve management of amyloid-related imaging abnormalities (ARIA). PMDA listing.

7–9. Apixaban: additional bleeding-risk minimisation materials

Roszdravnadzor published three separate educational packages for NABIKUIS, Vazolaid® and Apixaban manufactured by Pharmproekt. The healthcare-professional guides and patient cards address dosing, interactions, surgery and neuraxial procedures, switching anticoagulants and patient counselling. Documents: No. 01I-946/26, No. 01I-947/26, and No. 01I-948/26.

Implications for marketing authorisation holders

Companies should assess the impact on local product information, additional risk-minimisation measures, healthcare-professional and patient education, recall-management procedures and signal monitoring. Particular attention is warranted for anticoagulants, ARIA-risk medicines and quality defects affecting parenteral products.

This professional update is based on official regulator communications and is intended for pharmacovigilance and regulatory-affairs specialists.