Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 7 April 2025.
Summary
Isotretinoin, originally sold as Roaccutane, is a prescription medicine used to treat patients with severe cystic acne who have not seen improvement after conventional therapy, including systemic antibiotics.
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
- 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) and Consumer Medicine Information (CMI) documents are being updated as a precautionary measure and to align with international regulatory advice.
What health professionals should do
Health professionals should be alert to the potential psychiatric and sexual disorders associated with isotretinoin. These side effects can result in serious consequences, especially considering that isotretinoin is often used in adolescents.
You should be alert to patients who show signs of:
- depression
- psychotic behaviours
- suicidal thoughts and actions (rare)
- sexual dysfunction, including erectile dysfunction
- decreased sex drive (libido)
- vulvovaginal dryness
- feeling numb or indifferent (anhedonia)
- enlarged breasts in males (gynaecomastia).
Before initiating isotretinoin, prescribers are advised to assess patients’ mental health as well as their family history of mental health conditions.
Health professionals should monitor for depression and sexual disorders both before and during treatment. If these symptoms occur, cease treatment immediately. It is possible that discontinuation of treatment may not alleviate symptoms and further specialist evaluation may be necessary.
There is a range of generic isotretinoin products on the market, subsidised by the Pharmaceutical Benefits Scheme as ‘authority required (streamlined)’ with different requirements in various jurisdictions. All generics will be required to align their PI and CMI documents with Roaccutane.
See the full article on the TGA website.
