MHRA Drug Safety Update: Isotretinoin – changes to prescribing guidance and additional risk minimisation measures

The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin, following a review of the impact of the measures implemented in 2023. We ask healthcare professionals to review these new measures and supporting materials and integrate them into their clinical practice.

Second prescriber no longer required plus updated risk minimisation measures

Following the review of the impact of the 2023 risk minimisation measures for isotretinoin and the October 2025 survey of dermatology services, the CHM has recommended an updated approach to the prescribing requirements for isotretinoin. From today, healthcare professionals can prescribe isotretinoin to those under 18-years old without seeking the agreement of a second prescriber.

However alternative risk minimisation measures have been introduced to ensure isotretinoin continues to be prescribed and dispensed safely and all other existing risk minimisation measures continue to remain in place. The updated approach is designed to strengthen the Medicines and Healthcare products Regulatory Agency’s (MHRA) ability to monitor safe prescribing while supporting patient access to treatment.

The associated Public Assessment Report contains further details of the data considered and advice given by CHM.

Advice for healthcare professionals

Healthcare professionals are asked to review these new measures and supporting materials and integrate them into their clinical practice

Second prescriber requirement for under 18s no longer required

• The second prescriber regulatory requirement for patients under 18 years of age has been replaced by alternative risk minimisation measures. The product information for isotretinoin will be updated over the coming months to reflect this change. Services can implement this change immediately, although we acknowledge that some transition time may be required

New Risk Minimisation Measures

• the Acknowledgement of Risk Form for all patients has been updated. The digital version is now available online and should be used in clinical practice as soon as is feasible. Hardcopies will be available in the coming months (see section below for further information). The revised Acknowledgement of Risk Form:

  a) asks the patient to confirm that they understand the therapeutic indication of isotretinoin. The prescriber is also asked to confirm that isotretinoin is clinically indicated for the patient and that there is no other appropriate effective treatment. This provides additional safeguards on appropriate prescribing for all patients

  b) asks the patient to confirm that they understand they can seek a second opinion about their treatment

  c) has been streamlined to fit two pages

• a clinical audit of risk minimisation measures is to be developed and implemented by the British Association of Dermatologists (BAD). Healthcare professionals are expected to fully engage in the clinical audit which will be initiated in 2026 (see section below for further information)
• a patient information video has been produced by the BAD with oversight from the MHRA and CHM, to explain the risks associated with isotretinoin treatment in an accessible format. Healthcare professionals should advise patients to watch the video prior to starting treatment. (see full alert for further information). Patients will need to confirm they are aware of the video on the Acknowledgement of Risk Form

Existing Measures

• healthcare professionals should continue to follow the other existing measures including:
  • patients should continue to be counselled about the potential mental health and sexual side effects of isotretinoin, and monitoring of these side effects should continue to take place throughout treatment
  • patients of child-bearing potential should continue to be entered into the Pregnancy Prevention Programme (this also applies to other oral retinoid medications)
  • healthcare professionals should continue to use the patient reminder card and pharmacist checklist
  • prescribers should assess a patients’ mental health before prescribing isotretinoin including the use of patient-reported outcome measures and ask patients about any sexual function concerns before prescribing isotretinoin
  • prescribers should monitor patients for side effects including mental health and sexual function side effects at each follow up appointment including objective mental health patient reported outcome measures
  • the Lead Prescriber, who initiates isotretinoin treatment, must have expertise in the use of systemic retinoids for the treatment of severe acne and a full understanding of the risks of isotretinoin therapy and monitoring requirements

Reminder of October 2025 changes to isotretinoin guidance

• healthcare professionals are also reminded about the updates and clarifications to the isotretinoin prescribing advice announced in October 2025:
  • follow-up consultations do not necessarily need to be in person (face to face) and could be remote if appropriate, however the first appointment should be in person
  • medically supervised pregnancy testing may be performed remotely with appropriate oversight to ensure tests are performed correctly and safely
  • patients should be asked about sexual function at follow up appointments, although by the third appointment, this may be brief
• healthcare professionals should continue to report any suspected adverse drug reactions associated with isotretinoin on a Yellow Card

View the full alert here.