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.