Drug Safety

MHRA Alert – Isotretinoin prescribing guidance and risk minimisation updates

Isotretinoin: Updated prescribing guidance

The Commission on Human Medicines (CHM) has endorsed changes to the risk minimisation measures for isotretinoin following a review of measures implemented in 2023. Healthcare professionals are asked to review the updated guidance to ensure safe prescribing and patient management.

Key points

  • Risk minimisation measures for isotretinoin have been reviewed and updated
  • Changes follow assessment of the effectiveness of 2023 measures
  • All prescribers, pharmacists and other healthcare professionals should familiarise themselves with the new requirements
  • Patient safety remains the priority in isotretinoin therapy

Affected medication

  • Isotretinoin (all formulations and brands)

What you need to do

  • Review the full MHRA guidance on the updated risk minimisation measures
  • Ensure your team understands the changes before prescribing or dispensing isotretinoin
  • Communicate relevant updates to patients currently on isotretinoin therapy
  • Refer to the MHRA source document for complete prescribing requirements

For the full alert and detailed guidance, visit the MHRA drug safety update.