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.
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.
"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".
Source: Medscape, 1 November 2023