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New safety measures in place for prescribing oral isotretinoin (roaccutane) for severe acne

The UK government have launched a strengthened set of safety measures for the prescribing of a medicine used to used to treat severe acne. These measures include additional safeguards when prescribing isotretinoin to patients under 18 years old, along with closer monitoring of a patient’s mental health and sexual well-being during treatment.

October 31, 2023

Oral isotretinoin (roaccutane) is a very effective treatment for severe acne or when there is a risk of permanent scarring. However, it is only recommended for use when other treatments have not been effective. This is because whilst it has helped many patients with their severe acne, improving their skin and their overall wellbeing, patients and members of the public have raised concerns about suspected psychiatric (mental health) and sexual side effects.

In response to these concerns, a patient-focused independent expert review of suspected mental health and sexual side effects of isotretinoin was carried out. Following this independent report – published April 2023 by the Commission on Human Medicines’ Isotretinoin Expert Working Group – a number of recommendations were made with the aim of improving the safety of isotretinoin for the treatment of acne.

The new safety measures introduced today include the following:

  • Two independent prescribers need to agree to start a patient under 18 years on isotretinoin
  • New counselling requirements about potential mental health and sexual function side effects
  • Assessment of mental health and sexual function before starting treatment and monitoring of mental health and sexual function during treatment
  • New roles and responsibilities for healthcare professionals
  • New regulatory risk minimisation materials

The Medicines for Children team were approached by members of the Isotretinoin Expert Working Group to develop an information guide specifically for young people who are thinking about starting a course of oral isotretinoin.

This guide is an important addition to the current resources available to young people so that they and their families can have access to the full information on the potential risks and benefits of isotretinoin before making the decision to take it. It was essential that the information guide was written in a format that is easy to understand and sets out the possible side effects so that young people and their families are fully informed before they start taking the medicine.

The team are very grateful to the young people from Great Ormond Street Hospital’s Young Person’s Advisory Group who gave up their time to work with us on developing this guide to isotretinoin. We would like to thank them for their insightful feedback in helping to ensure that this information is accessible for young people and their families.

You can download the new guide by clicking the box above or via the permanent link on the Medicines for Children website:

The statement on this work from the U.K. Government is available to read in full on their website here:  Treatment with isotretinoin for patients under 18 must be approved by two prescribers, under new MHRA rules – GOV.UK (