Medicines Healthcare Products Regulatory Agency
Materials and links to support new safety position
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, theCommission 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:
- 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.
- 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.
- To consider the impact of the available information on psychiatric effects and sexual disorders on the balance of benefits and risks of isotretinoin.
- 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.
- 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 IEWGwas 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:
- Report of the Commission on Human Medicines Isotretinoin Expert Working Group
- Isotretinoin expert safety review a plain language summary of the recommendations.
For more information on the announcement of the recommendations in April 2023 see:
- News story: Outcome of the expert review of the safety of isotretinoin
- Drug Safety Update for healthcare professionals.
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 t