UPDATES

The Isotretinoin Expert Working Group of the Commission on Human Medicines has made recommendations to strengthen the safety of isotretinoin treatment. Recommendations include new warnings, the need for consistent monitoring requirements for psychiatric side effects, the introduction of new monitoring requirements for sexual side effects, and additional oversight of the initiation of treatment for patients younger than 18 years.

In September 2019, the Commission formed the Working Group to review the safety of isotretinoin, in particular concerns about suspected psychiatric and sexual side effects and whether, in some cases, these continue after use of isotretinoin has been stopped. While processes to support the implementation of these recommendations across the healthcare system are being developed, prescribers of isotretinoin are reminded of the need to fully inform all patients of the potential benefits and risks associated with isotretinoin treatment and monitor patients closely for any side effects throughout treatment.

No new action from healthcare professionals is needed for now – further communications will be issued once these recommendations are being implemented. Recommendations include the addition of new warnings for the risk of sexual dysfunction, including the possibility of persistence after treatment discontinuation, and advice for healthcare professionals to ask patients about symptoms or signs of sexual dysfunction prior to starting treatment with isotretinoin and to monitor patients for the development of new sexual disorders during treatment.