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The Commission on Human Medicines (CHM) has endorsed changes to guidance for prescribing acne medication isotretinoin (Roaccutane; Cheplapharm or Reticutan; Ennogen Healthcare), for which some patients have reported mental health and sexual disfunction side effects.
According to the updated guidance published on 31 October 2025 by CHM’s Isotretinoin Implementation Advisory Expert Working Group, patients should be asked about mental health and sexual dysfunction side effects at follow-up consultations; however, these consultations do not necessarily need to be face to face and could be remote, if appropriate.
The CHM also endorsed updated guidance from the British Association of Dermatologists (BAD), also published in October 2025, which advises that pregnancy testing can be supervised remotely with appropriate guidance and oversight via the consideration of the clinical assessment, the patient’s needs and preferences and safeguarding considerations.
A spokesperson for the BAD commented: “The guidance strikes the balance between safeguarding patient wellbeing and preserving access to treatment for those with severe acne”, and “maintain a strong focus on informed decision-making and patient-centred care”.
Henrietta Hughes, patient safety commissioner for England, said: “Isotretinoin is a highly effective medication for severe acne. However, due to the risks of teratogenicity, psychiatric and sexual side effects, this must be balanced by rigorous adherence to safety guidelines. Appropriate patient selection, informed consent and monitoring are key so the tragic side effects experienced in the past by patients and families are not repeated.
“The patient safety principles set out the way that decisions can be made, which include the patient’s perspective, identifying and mitigating risks with transparency and accountability, to put the patient at the heart of everything we do and create a culture of safety.”
In a drug safety update published on 27 October 2025, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that it will conduct a survey of both NHS and private prescribing of isotretinoin for acne.
The resulting data from its survey will be held by the MHRA, which will provide anonymised summary statistics to the CHM to support its advice on possible options for further modifications to the isotretinoin risk-minimisation measures, it said.
The deadline for completing the survey is 16 November 2025.
