Outcome of the expert review of the safety of isotretinoin

Following an in-depth expert safety review of the acne drug isotretinoin (commonly known by brand names Roaccutane and Reticutan), the Commission on Human Medicines (CHM) has agreed to a number of recommendations to strengthen the safe use of the treatment.

Isotretinoin is used to treat severe forms of acne, especially if there is a risk of permanent scarring. This medicine is an extremely effective last-line treatment for severe acne. However, patients and members of the public have raised concerns about suspected side effects associated with isotretinoin, including psychiatric (mental health) and sexual side effects that sometimes continue after treatment with isotretinoin has been stopped.

Key recommendations include:

• Better information for patients and their families about the risks of isotretinoin so that they can make an informed decision before using this medicine.
• Consistent monitoring of a patient’s psychiatric and sexual health so that any problems are spotted earlier and there are defined routes for patients to receive help.
• Tighter controls on first prescribing isotretinoin to young people (aged 12 to 18) so that it is only started when doctors agree the acne is severe enough to justify it and that other standard treatments have been sufficiently tried and haven’t worked.

Patient Safety Commissioner, Henrietta Hughes tweeted last night: "I welcome the new recommendations from @MHRAgovuk to strengthen the safe use of isotretinoin. Courageous patients and families have shared their experience with the review. It’s only by listening and acting that we can meet patients’ needs."

Read MHRA press release, 26 April 2023