其 他 安 全 警 示
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| Australia: New safety warnings for isotretinoin (Roaccutane) (English only) |
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The Therapeutic Goods Administration (TGA) announces that 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) are being updated as a precautionary measure and to align with international regulatory advice.
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.
According to the Australasian College of Dermatologists, patients with acne may suffer from poor body image, low self-esteem, experience social isolation and avoid participating in daily activities, which persist long after the active lesions have disappeared. Increased levels of anxiety, anger, depression, and frustration are also observed among patients with acne, often a result of the emotional impact. The college advises that isotretinoin is effective in treating mild-moderate, severe, persistent and/or scarring acne. The college updated its position statement on the use of isotretinoin for the treatment of acne in October 2024.
The TGA initially investigated the association between isotretinoin and psychiatric adverse reactions in 2016, concluding that the then-current warnings in the Australian PI were appropriate. It published an Medicines Safety Update to remind prescribers of the risks and the need for careful psychological assessment prior to and during isotretinoin treatment. The UK Commission on Human Medicines Isotretinoin Expert Working Group published a report on isotretinoin and the risk of psychiatric and sexual disorders in April 2023. Health Canada published a summary safety review in June 2024 regarding isotretinoin and the potential risk of sexual dysfunction, including persistent sexual dysfunction after drug discontinuation.
The TGA undertook an investigation to review all current information on these safety signals. The investigation concluded that an association between isotretinoin and psychiatric/sexual disorders could not be ruled out. Given the reported cases of severe and sometimes persisting adverse events and that isotretinoin is commonly used to treat severe cystic acne in adolescent populations, it was recommended the PI be updated as a precautionary measure and to align with international regulators.
Changes to the isotretinoin PI include update of relevant text regarding psychiatric disorders and sexual disorders. For details, please refer to the website in TGA.
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. Health professionals 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); and 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.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/new-safety-warnings-isotretinoin-roaccutane
In Hong Kong, there are 13 registered pharmaceutical products containing isotretinoin. All products are prescription-only medicines. So far, with regard to isotretinoin, the Department of Health (DH) has received 2 cases of adverse drug reaction, but these cases were not related to psychiatric and sexual disorders.
Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 27 Oct 2017, with the latest update posted on 26 Jul 2024. Letters to inform local healthcare professionals were issued by the DH on 27 Oct 2017 and 27 Apr 2023. In Oct 2024, the Registration Committee of the Pharmacy and Poisons Board discussed the matter and decided that the sales pack labels and/or package inserts of locally registered pharmaceutical products containing isotretinoin should contain the strengthened safety information about the risk of psychiatric and sexual disorders. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities.
Ends/Tuesday, Apr 8, 2025
Issued at HKT 17:15
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