Isotretinoin (Roaccutane): introduction of new safety measures

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced new safety measures for Isotretinoin (Roaccutane). These new safety measures strengthen the safe use of isotretinoin through the introduction of additional oversight of the initiation of isotretinoin in patients under 18 years and through improved assessment and monitoring of mental health and sexual function issues.

Healthcare professionals are asked to review these new measures and supporting materials and integrate them into their clinical practice when referring patients and when prescribing or dispensing isotretinoin.

New compulsory regulatory risk minimisation materials have been developed for use with all patients consisting of an Acknowledgement of Risk Form, a Patient Reminder Card and a Pharmacist Checklist. These are available electronically and will be sent to relevant healthcare professionals by post.

Further information, a summary of measures and advice can be found on the MHRA website.