New safety warnings for isotretinoin from TGA

Australia’s Therapeutics Goods Administration (TGA) has issued a safety notice on isotretinoin, originally sold as Roaccutane by Swiss pharma giant Roche (ROG: SIX). This is a prescription medicine used to treat patients with severe cystic acne who have not seen improvement after conventional therapy, including systemic antibiotics.

The TGA said additional safety information will be added to all isotretinoin products, further highlighting the recognised potential risks of mood-related changes and sexual disorders. The update includes: new advice to conduct a mental health assessment for all patients before starting isotretinoin; what to do if mood-related changes develop; and new warnings and advice added regarding sexual health-related side effects.

This safety update follows a TGA safety investigation conducted in 2024 after international regulators strengthened warning about psychiatric and sexual disorders for isotretinoin. As a result, the Product Information (PI) - external site and Consumer Medicine Information (CMI) - external site are being updated as a precautionary measure and to align with international regulatory advice.