Two medicine safety updates — 25 August 2026

25 August 2026 — PharmExpert highlights two official medicine-safety updates relevant to marketing authorisation holders, pharmacovigilance teams and healthcare professionals.

1. Australia: CAROTONE products contain undeclared prescription-only hydroquinone

The Therapeutic Goods Administration (TGA) tested three imported, unapproved skin-brightening products: CAROTONE Brightening Oil 65 mL, CAROTONE Clarifying Cream 300 mL and CAROTONE Brightening Body Lotion 350 mL.

Testing found undeclared hydroquinone concentrations of 3.6%, 2.9% and 3.4%. In Australia, products containing more than 2% hydroquinone are prescription-only medicines. The TGA considers the tested products counterfeit therapeutic goods and warns that hydroquinone can cause serious side effects, particularly when used without medical advice.

Consumers should stop using the products, take remaining stock to a pharmacy for safe disposal, seek advice from a healthcare professional if concerned, and report suspected adverse events. The TGA is also working with the Australian Border Force to intercept future shipments.

Importance: High — undeclared prescription medicine, counterfeit products and a direct patient-safety warning.

Official TGA safety alert

2. Japan: PMDA/MHLW opens evaluation of new drug-safety signals

The Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) added new risk information under ongoing evaluation. The update covers:

• Azathioprine: posterior reversible encephalopathy syndrome and sinusoidal obstruction syndrome/veno-occlusive disease.
• Tocilizumab: drug-induced hypersensitivity syndrome.
• Apremilast: hepatic impairment.
• Alectinib: severe hypertriglyceridaemia.
• Pembrolizumab: severe oesophagitis.
• Atezolizumab, avelumab, cemiplimab, tislelizumab, durvalumab, tremelimumab and retifanlimab: severe gastritis and severe oesophagitis.
• Ipilimumab: severe gastritis.
• Osimertinib: aplastic anaemia.
• Selpercatinib: oculomucocutaneous syndrome (Stevens–Johnson syndrome).

These are signals under regulatory evaluation, not completed package-insert changes. PMDA advises patients not to stop treatment or reduce the dose without consulting a physician.

Importance: High — official evaluation of multiple serious potential adverse reactions.

Official PMDA Risk Communications

Why this matters

Marketing authorisation holders and pharmacovigilance teams should track the resulting regulatory assessments and any subsequent label or risk-minimisation changes in the affected markets.

This update is for regulatory intelligence purposes and does not replace medical or legal advice.