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

AI Summary

The Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) have issued updated safety guidance for isotretinoin, a potent treatment for severe acne marketed under brand names like Roaccutane and Reticutan. This update follows a comprehensive safety review initiated in November 2020 to address serious concerns regarding suspected psychiatric side effects and sexual dysfunction that may persist after stopping treatment. Under the current regulatory framework, the MHRA has implemented several risk minimization measures to ensure patient safety while maintaining access to this effective medication. A significant change effective January 22, 2026, removes the previous requirement for a second prescriber’s sign-off when treating patients under the age of 18. However, other strict protocols remain mandatory. Required actions for healthcare providers include ensuring all patients view a new educational video before starting therapy and sign an updated Acknowledgement of Risk Form. Additionally, the British Association of Dermatologists (BAD) will implement clinical audits to monitor compliance with these safety measures. Prescribers must continue to use patient reminder cards and pharmacist checklists, ensuring isotretinoin is only used as a last-line treatment for severe acne that has failed to respond to standard therapies like antibiotics. These measures aim to enhance transparency regarding long-term risks and ensure informed decision-making for patients and their families.