Five medicine safety updates — 26 August 2026
- 26-08-2026
- Posted by: Eldaniz Hasanov
- Category: Regulatory Updates
26 August 2026 — PharmExpert highlights five official medicine safety updates relevant to marketing authorisation holders, pharmacovigilance teams and healthcare professionals.
1. United Kingdom: new advice for finasteride, dutasteride, sotorasib and elranatamab
The MHRA updated advice for several medicines. Warnings for finasteride and dutasteride now place greater emphasis on psychiatric adverse effects and sexual dysfunction. For sotorasib, more frequent liver-function monitoring is advised in patients who received immunotherapy during the previous three months, with updated actions for drug-induced liver injury and interstitial lung disease.
Progressive multifocal leukoencephalopathy is now recognised as an adverse reaction to elranatamab. The MHRA reports ten cases, including fatal outcomes. Treatment should be withheld and investigated when PML is suspected, and permanently discontinued if it is confirmed.
Importance: high — the changes concern serious and potentially fatal reactions, monitoring and treatment interruption.
2. Canada: Twins Herbal Idakole/Pelorie recalled for undeclared sildenafil
Health Canada announced a Type I recall of all lots of Twins Herbal Idakole/Pelorie liquid products (RA-82524). The unauthorised products contain undeclared sildenafil. Consumers are advised to stop use, consult a healthcare professional about health concerns and report adverse reactions.
Importance: critical — an undeclared prescription medicine creates a risk of serious interactions and complications.
3. Switzerland: Alecensa (alectinib) and severe hypertriglyceridaemia
Swissmedic issued a healthcare-professional communication on a new serious adverse reaction to Alecensa: severe and potentially life-threatening hypertriglyceridaemia. Post-marketing cases of pancreatitis have also been reported. The advice includes measuring triglycerides before treatment and periodically thereafter, monitoring for symptoms of pancreatitis, temporarily interrupting treatment when required, and reassessing the benefit–risk balance before restarting.
Importance: high — the new serious reaction requires laboratory monitoring and may affect treatment decisions.
Official Swissmedic communication
4. France: dispensing-error risk for Siklos 100 mg and 1,000 mg
ANSM reported a new serious dispensing error and strengthened measures to prevent confusion between Siklos 100 mg and 1,000 mg, which can result in overdose or underdosing. Prescribers should clearly state the strength, body weight and age and explain the regimen; pharmacists should verify the prescription against the supplied pack and use the updated materials for professionals and patients.
Importance: high — the tenfold difference between strengths creates a clinically significant medication-error risk.
5. United States: Baxter recalls one lot of 70% Dextrose Injection USP
Baxter is voluntarily recalling one lot of 70% Dextrose Injection USP: product code 2B0296H, lot Y495066, expiry 31 July 2027, 2,000 mL VIAFLEX Pharmacy Bulk Package. The reason is the potential presence of stainless-steel particles.
Particles entering the vascular system may cause blockage, clotting, pulmonary embolism, permanent organ damage or death; local irritation, inflammation, worsening infection and allergic reactions are also possible. No adverse events had been reported at the time of the notice. Healthcare facilities should stop use and return the product, and home-care patients should be alerted.
Importance: critical — potential intravascular administration of metallic particles carries a risk of severe harm or death.
Practical implications
Marketing authorisation holders and pharmacovigilance teams should assess the relevance of these signals and measures to their products and update monitoring, communications and risk-minimisation procedures where appropriate.
This material is intended for regulatory intelligence and does not replace medical or legal advice.