Guidance

Isotretinoin: an expert review of suspected psychiatric and sexual side effects

The review of the safety of isotretinoin has concluded.

From:
Medicines and Healthcare products Regulatory Agency
Published
10 November 2020
Last updated
31 October 2023 — See all updates

On 31 October 2023 the MHRA published guidance and materials to support the new regulatory advice for isotretinoin following the expert review of suspected psychiatric and sexual side effects.

For more information see our Press Release and the Drug Safety Update (published 31 October 2023).

See Report of the Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group for comprehensive guidance and advice on interpretation of the regulatory position.

See the new regulatory advice in the Summary of Product Characteristics (SmPC) and the Patient Information Leaflet (PIL).

For the new risk minimisation materials, see:

For clinical resources please consult the page from the British Association of Dermatologists.

Background

Isotretinoin is used to treat severe forms of acne, especially if there is a risk of permanent scarring. It should only be prescribed to treat severe forms of acne that have not responded to other treatments, such as antibiotics and topical treatments (creams or gels).

Isotretinoin capsules are also known by the brand names Roaccutane and Reticutan in the UK, and may be known as Accutane in other countries.

Isotretinoin is an extremely effective last-line treatment for severe acne. However, patients and members of the public have raised concerns about suspected side effects associated with isotretinoin, including mental health and sexual side effects that sometimes continue after treatment with isotretinoin has been stopped. In light of these concerns, the Commission on Human Medicines (CHM) formed the Isotretinoin Expert Working Group and asked it them to look at the overall safety of the medicine.

This page outlines the scope of the review, the recommendations, and the materials and communications on the safety changes. Information has been left on this page as a record for how the MHRA asked patients and stakeholders for evidence.

Scope of the safety review

The Medicines and Healthcare products Regulatory Agency (MHRA) routinely undertakes reviews of the safety of medicines, seeking independent expert advice from the Commission on Human Medicines. The MHRA is responsible for the safety, efficacy and quality of medicines and this safety review focused on the regulatory position in the UK.

The terms of reference for the IEWG were:

  1. To evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on psychiatric effects suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
  2. To evaluate information from all available sources, including relevant stakeholders (patients, patient representatives, healthcare professionals, healthcare organisations, researchers, charity and patient organisations) on sexual disorders suspected to be associated with isotretinoin. To consider whether regulatory action is required to minimise risk and ensure awareness of the risks.
  3. To consider the impact of the available information on psychiatric effects and sexual disorders on the balance of benefits and risks of isotretinoin.
  4. To consider what research could be undertaken to further elucidate any risks and long-term impact of psychiatric effects and sexual disorders and inform risk minimisation measures.
  5. To make recommendations to the Commission on Human Medicines to improve the balance of benefits and risks for isotretinoin, to raise awareness of the associated risks and for further research to evaluate the risks.

The IEWG was an independent group of medical and scientific experts, as well as lay representatives and observers from relevant clinical organisations. The IEWG has reviewed the available information on isotretinoin, including the experiences of patients and their families.

Membership of the IEWG was selected from those with relevant expertise in the UK. All members declared their interests and followed the conflict of interests policy.

Recommendations from the safety review

Following the in-depth safety review, the Commission on Human Medicines (CHM) agreed a number of recommendations to strengthen the safe use of the treatment.

Full details of the recommendations can be found in the:

For more information on the announcement of the recommendations in April 2023 see:

The CHM formed a new Implementation Advisory Expert Working Group to:

  • advise on how to implement these recommendations
  • help develop the communication and educational materials for patients to support and record informed prescribing decisions
  • monitor impact and effectiveness of these new measures
  • advise and make recommendations on future research and a registry

The Implementation Advisory Expert Working Group was composed of experts and representatives of the healthcare organisations who will be involved in the implementation of these recommendations. The will reported back to the CHM on an agreed approach on how to implement the recommendations successfully at a future meeting. See Report of the Commission on Human Medicines Isotretinoin Implementation Advisory Expert Working Group for comprehensive guidance and advice on interpretation of the regulatory position.

Contributions from patients and the public

Call for information

The call for information is now closed.

A call for information was held for 14 weeks (10 November 2020 to 16 February 2021). A total of 710 complete responses were received. These included 659 responses that provided views. We have assessed each one and shared the responses with the IEWG.

Thank you to everyone who responded, we appreciate the time and effort made to contribute to the review.

IEWG meeting with stakeholders to receive further information

This opportunity is now closed.

Patients and other stakeholders presented information about their experience of isotretinoin and what aspect of treatment has had the greatest impact as well as how the risks associated with isotretinoin should be managed.

Three sessions were held to allow the IEWG to hear from everyone who registered and wished to present.

See recordings of the 3 IEWG sessions with stakeholders. These videos have been edited to only show the views of those who consented to being recorded. The videos contain content that some people may find upsetting:

Thank you to everyone who presented or provided additional information, we appreciate the time and effort made to contribute to the review.

Meeting of the CHM to consider the safety review

Patients and other stakeholders have been involved throughout the isotretinoin safety review.

The information reviewed by the IEWG was presented to the CHM on Friday, 17 December 2021 for consideration of the next step of the isotretinoin review.

The CHM meeting was held in two sessions, the first session considered the information reviewed by the IEWG and the second session considered the IEWG’s recommendations and the regulatory action needed.

Although the content and proceeding of CHM meetings are strictly confidential, patients and other stakeholders who contributed or had an interest in the safety review were able to register to watch the first session of the CHM meeting.

Stakeholders were able to comment and raise questions online which were considered by CHM. Questions that were not answered during the session were responded to individually .

Reporting suspected side effects to isotretinoin

The MHRA continuously monitors the safety of medicines in the UK using information from various sources including the Yellow Card scheme.

If you suspect that you have experienced a side effect with use of isotretinoin, we encourage you to submit a report. Anyone in the UK can submit a report to the Yellow Card scheme. Anyone outside the UK should submit a report to the regulatory authority in their country. Submitting reports of suspected side effects through schemes, such as the Yellow Card Scheme, is the most secure way to provide this information. This will ensure your experience is considered within this safety review and contributes to the ongoing monitoring of the safety of isotretinoin.

We are particularly interested in receiving information about possible psychiatric or sexual side effects. If you have already submitted a Yellow Card report, you do not need to submit a new report, unless you wish to provide additional information which can be used to update your original report.

The Yellow Card reports collect information about a number of different aspects and every report is appreciated.

Further help and support

For further help and support, in the first instance, always talk to your GP or healthcare professional.

For further help and information on different skin conditions, the British Association of Dermatologists (BAD) has a dedicated webpage for a range of patient support groups for different skin conditions. Information is on NHS website pages for skin conditions and acne.

For further help and information on mental health issues, please go to the NHS website (Self-harm and Suicidal thoughts).

Mind also offers information on a range of mental health problems and support options.

For information, advice and resources on children and young people’s mental health, visit the YoungMinds website (with support for young people, parents and professionals).

Contact

If you have any questions about this safety review please contact us at info@mhra.gov.uk.

Data Protection and Privacy Information

Introduction

You can read the MHRA Privacy Notice to find out in general terms the types of personal data we process and why, as well as information about your rights and how to raise concerns.

This policy sets out the approach the safety review has taken in order to handle information appropriately and to comply with information legislation.

This policy covers documents gathered and created during this review and anything in which information of any description is recorded, whether in paper or electronic form.

The Safety Review complied with Data protection legislation including Data Protection Act 2018 and the UK General Data Protection Regulation (GDPR).

We rely on UK GDPR Article 6(1)(e) as our legal basis for processing your personal data. This allows us to process personal data when this is necessary for the performance of our public tasks in our capacity as a regulator.

Information provided to the MHRA and for consideration by the Isotretinoin Expert Working Group may include some special category personal data, such as health information. Our lawful bases for processing such information are set out in UK GDPR Article 9(2)(i) and the Data Protection Act Schedule 1, Part 1(3). Both relate to situations where the processing is necessary for reasons of public interest in the area of public health.

Lawful basis and purpose of processing personal information

The Safety Review collected and used personal information and sensitive personal information, for the purposes of fulfilling the terms of reference of the Review, which are published on the MHRA’s website.

Individuals whose personal information was held by the review gave their consent to use their information for the Safety Review’s purposes. In the case of personal information, the purpose is to read and analyse the information provided to improve understanding of issues raised by individuals and organisations and to make recommendations as required by the Terms of Reference.

The information may also be used to help explore issues and direct further areas of research.

Security and confidentiality

Only members of the MHRA secretariat and the Isotretinoin Expert Working Group will have access to personal information. Everyone is aware of their obligations and responsibilities when handling personal and confidential information. They are subject to employment, contractual and other professional obligations regarding confidential and official information, both during the safety review and afterwards.

All personal and sensitive information is stored securely to prevent loss or inappropriate access.

Sharing information

The MHRA will hold the personal information you provide as part of the safety review until 26 April 2025 and use it for analysis and for the purpose of fulfilling the terms of reference of the Isotretinoin Expert Working Group.

We will not sell your personal data and don’t intend to share your personal data with any third party other than our data processors who act only upon our instructions and those of the Isotretinoin Expert Working Group. We will handle any specific requests from a third party for us to share your personal data with them in accordance with data protection laws.

Retention and destruction of documents

We will retain the responses to the call for contributions until our work on the review is complete.

We have now published the final report of the safety review outlining its findings and recommendations.

The contributions will be retained until 26 April 2025 which is a period of 2 years after the final report of the safety review was published.

Rights

You have several rights which are outlined in the MHRA Privacy Notice. For greater detail on when they apply please refer to the Information Commissioner’s website.

If you wish to exercise any of your rights, please email dataprotection@mhra.gov.uk

If you have any questions for concerns, please contact our Data Protection Officer dataprotection@mhra.gov.uk

Published 10 November 2020

Published 10 November 2020
Last updated 31 October 2023 + show all updates

  1. Links added to further communications and materials to support the further announcement on implementation.

  2. The review of the safety of isotretinoin has concluded.

  3. Updated to include meeting of the CHM to consider this review

  4. Updated the opportunities to contribute section to include two new meetings for public contribution.

  5. The call for information is now closed. The Isotretinoin Expert Working Group will be holding a meeting with patients and stakeholders – more information and a registration link for this meeting have been added.

  6. The deadline for consultation has been extended until 16 February 2021

  7. First published.

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