Isotretinoin (Roaccutane)

Isotretinoin, originally sold as Roaccutane, is a prescription medicine used to treat patients with severe cystic acne who have not seen improvement after standard therapy.

There are various generic versions available and new safety information will be added to all isotretinoin products. This information further highlights the recognised potential risks of mood-related changes and potential 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 about sexual health-related side effects.

What patients or their carers should do

You should immediately let your doctor know if you, your child or someone you care for who is taking isotretinoin starts to have:

• depression (sad mood)
• change in behaviours including being aggressive and restlessness
• suicidal thoughts and actions (rare)
• sexual dysfunction, including erectile dysfunction
• decreased sex drive
• vulvovaginal dryness
• feeling numb or indifferent
• enlarged breasts in males.

What health professionals should do

Be alert to the updated warning in the isotretinoin Product Information - external site and Consumer Medicine Information - external site.

Health professionals should:

• be alert and look out for potential psychiatric and sexual disorders with isotretinoin, especially in adolescents
• assess patients’ mental health and their family history of mental health conditions before starting isotretinoin
• stop treatment immediately if mood-related changes occur and seek specialist advice if symptoms continue after stopping treatment
• provide the CMI - external site to patients if needed and alert them of the new warnings.

For more detailed information written for health professionals, including the full text of additional warnings, see the Medicines Safety Update article.