The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today (31 October 2023) introduced a number of regulatory changes to strengthen the safe use of isotretinoin, the acne medicine commonly known by brand names Roaccutane and Reticutan. These 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.
Isotretinoin is an effective treatment for severe acne or when there is a risk of permanent scarring and should only be used when other treatments have not been effective. While 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 has been carried out, leading to new safety measures introduced today. The safety review considered all the available evidence, including information from patients and their families, and concluded that the gaps in the available evidence meant that it was not possible to say that isotretinoin definitely caused many of the short-term or long-term psychiatric and sexual side effects. However, the individual experiences of patients and families continue to cause concern. It recommended that action should be taken to make sure patients are made aware of these potential risks, that they are carefully monitored during treatment, and that for patients under the age of 18 there are additional safeguards on isotretinoin prescribing.
The new safety measures, developed with input from patients and healthcare organisations, have been introduced to ensure that patients across the UK are better informed to make decisions about their treatment and so that they receive appropriate care and monitoring throughout treatment. These are:
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Additional oversight for patients under 18: for patients aged 12 to 18 years old, a second healthcare professional, in addition to a specialist in dermatology who acts as the Lead Prescriber, must independently assess the patient and determine whether isotretinoin is the only appropriate effective treatment. This means that, before isotretinoin is prescribed to anyone under 18, two independent healthcare professionals must agree that the acne is severe and that it has not responded to adequate courses of standard therapy. The roles and responsibilities of the two prescribers are fully described in the final report.
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Better information on potential risks: patients will receive more detailed information about the potential risks of isotretinoin, alongside its benefits.
The product information will be updated to state that healthcare professionals must counsel patients and their families on the risk of psychiatric and sexual side effects. Potential sexual side effects will be listed. Patients and their families must have sufficient time to consider this information and be able to ask questions before starting treatment.
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Improved monitoring and assessment of mental health and sexual wellbeing: all patients will have in-person assessments of their mental and sexual health before starting treatment with isotretinoin. They will also be monitored for side effects, including mental health and sexual function side effects, at each follow up appointment. New resources for healthcare professionals have been developed to support the appropriate monitoring of patients.
Isotretinoin can seriously harm an unborn baby and so can only be prescribed to female patents under a strict Pregnancy Prevention Programme.
The Commission on Human Medicine's Isotretinoin Implementation Expert Advisory Working Group, composed of experts from fields including dermatology, general practice, and psychiatry, has advised the MHRA on the introduction of the new measures.
The MHRA worked closely with this group to develop new guidance on the prescribing of isotretinoin, including information about the healthcare professionals who are able to prescribe and treat patients who require isotretinoin treatment.
The British Association of Dermatologists, the British Dermatological Nursing Group, and other stakeholders have produced supplementary documents to assist clinicians in adhering to the new guidelines.
Dr Alison Cave, MHRA Chief Safety Officer, said:
Isotretinoin is an effective treatment that should only be used for acne that is severe or at risk of causing permanent scarring and when other treatments have not been effective.
Like all medicines, isotretinoin may be associated with potential side effects. For isotretinoin, there may be possible impacts on mental health and sexual function. While not every patient will experience them, the new measures will ensure that patients are well informed, that are carefully monitored throughout treatment, and that there is additional oversight on isotretinoin prescribing for patients under 18.
We want to thank all the patients and families whose experiences were vital in informing the review and shaping these important changes. We will continue to work with stakeholders, including the British Association of Dermatologists, to ensure a smooth and successful integration of the strengthened measures into healthcare practice.
If you have been prescribed isotretinoin and have questions or concerns, please discuss them with the healthcare professional responsible for your care.
Professor Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, said:
Following our endorsement of the recommendations made by the Isotretinoin Expert Working Group, the independent Commission on Human Medicines supports the introduction of strengthened safety measures for isotretinoin treatment by the MHRA.
We thank the Isotretinoin Implementation Advisory Expert Working Group for their advice on the effective introduction of the new measures into clinical practice. They have developed simple to follow guidance and supporting materials with support from stakeholders that will assist healthcare professionals in implementing these changes, and improve the benefit-risk ratio of isotretinoin.
We are very grateful to the patients and families who shared their experiences during the review process and contributed with their input for implementation. Your contributions were instrumental in making these changes possible.
Dr Henrietta Hughes, Patient Safety Commissioner, said:
I welcome the new measures from the MHRA to strengthen the safe use of isotretinoin, commonly known by brand names Roaccutane and Reticutan, and used to treat severe acne. This guidance follows a patient-focused independent expert review of suspected mental health and sexual side-effects.
The new measures will help to keep patients who are prescribed the drug safe and reduce the occurrence of potential severe side-effects.
Anna Rossiter, Medicines for Children Programme Manager at the Royal College of Paediatrics and Child Health, said:
It is essential that young people and their families have access to the full information on the potential risks and benefits of isotretinoin for the treatment of acne when deciding whether to take it. This information needs to be written in a format that is easy to understand and must set out the possible side effects that might be experienced so that young people and their families are fully informed before they start taking the medicine.
The 'Medicines for Children' team are pleased to have worked with the Commission on Human Medicine's Isotretinoin Implementation Advisory Expert Working Group to produce this important information leaflet on isotretinoin for young people.
In addition, we are 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 information. We would like to thank them for their insightful feedback in making sure that this information is accessible for young people and their families.
Healthcare professionals involved in the treatment of patients with acne, particularly prescribers of isotretinoin, should thoroughly review the complete requirements detailed in the Drug Safety Update and final report.
Anyone who suspects an adverse reaction to isotretinoin or any other medicinal product, should report it to the MHRA's Yellow Card scheme.
Notes
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In April 2023, the government's expert scientific body, the Commission on Human Medicines (CHM), recommended strengthened safety measures for isotretinoin following an expert safety review carried out by the independent CHM's Isotretinoin Expert Working Group.
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The Yellow Card scheme enables the MHRA to monitor safety concerns such as suspected side effects or adverse incidents involving healthcare products. These include medicines, vaccines, blood factors and immunoglobulin products, medical devices, e-cigarettes and complementary therapies such as homeopathies. Anyone can report to the Yellow Card scheme via the Yellow Card scheme website or app.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
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The MHRA is an executive agency of the Department of Health and Social Care.
