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New MHRA Rules for Treatment With Isotretinoin

Treatment with isotretinoin for UK patients under 18 years of age must be approved by two prescribers in a series of regulatory changes announced by the Medicines and Healthcare products Regulatory Agency (MHRA) to strengthen the safe use of this drug.

Isotretinoin, also known by the brand names Roaccutane and Reticutan, is an effective treatment for severe acne or when there is a risk of permanent scarring. While the drug has helped many patients with severe acne, concerns have arisen among patients and members of the public regarding suspected mental health side effects, including depression, anxiety, psychotic symptoms, and suicide, as well as sexual side effects.

Balance of Risks and Benefits Still Favourable

Following an expert safety review, the Commission on Human Medicines (CHM) agreed in April of this year to a number of recommendations to strengthen the safe use of the treatment.

The safety review concluded that because of gaps in the available evidence, it was not possible to say that isotretinoin definitely caused many of the short-term or long-term mental health and sexual side effects. However, since the individual experiences of patients and families continued to cause concern, the experts recommended that action be taken to ensure patients were made aware of these potential risks and that they were carefully monitored during treatment.

Additional safeguards on isotretinoin prescribing were recommended for patients under the age of 18 years.

"The overall balance of risks and benefits for isotretinoin remains favourable," the authors of the report concluded, but further action should be taken to ensure patients were fully informed about isotretinoin and were effectively monitored during and after treatment, they recommended.

Anna Rossiter, programme manager for Medicines for Children at the Royal College of Paediatrics and Child Health, said the information for young people and their families "needs to be written in a format that is easy to understand and must set out the possible side effects that might be experienced".

Strengthen Safe Use of Isotretinoin

Having recognised that implementation would require changes in organisational structures, regulatory advice, and clinical care, the CHM set up a multidisciplinary Isotretinoin Implementation Advisory Expert Working Group to advise on the best way to implement the recommendations.

The MHRA subsequently introduced a number of regulatory changes to strengthen the safe use of isotretinoin, and to ensure that patients were better informed to make decisions about their treatment and received appropriate care and monitoring — particularly of their mental health and sexual well-being — throughout treatment. 

The key recommendations are that there should be better:

  • Information: patients and their families should receive more thorough information about the risks of isotretinoin so they can make an informed decision before using it
  • Monitoring: consistent monitoring of a patient's mental health and sexual health should take place so any problems are spotted earlier, and there should be defined routes for patients to receive help
  • Checks: before first prescribing isotretinoin to young people, tighter controls should be in place so that it is only started when two doctors agree the acne is severe enough to justify it, and only if other standard treatments had been sufficiently tried and had not worked
  • Communication: patients should receive information about the risks of isotretinoin earlier, before they have a full discussion with a specialist dermatologist, so they have more time to consider fully the benefits and risks
  • Product information: healthcare professionals must counsel patients and their families on the risks of mental health and sexual side effects
  • Knowledge: further research should be done on the risks of mental health and sexual side effects associated with isotretinoin

Professor Mabs Chowdhury, president of the British Association of Dermatologists, told Medscape News UK that the Association would ensure the recommendations were implemented and that access to isotretinoin for appropriate patients would continue.

Professor Sir Munir Pirmohamed, CHM chair, said the guidance and supporting materials would assist healthcare professionals in implementing these changes, which would "improve the benefit-risk ratio" of isotretinoin.

Welcoming the new measures, Dr Henrietta Hughes, patient safety commissioner, said they would "help to keep patients who are prescribed the drug safe, and reduce the occurrence of potential severe side effects".

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