The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a review of the acne medication isotretinoin (Roaccutane, Reticutan and Rizuderm), particularly in relation to a possible association with psychiatric and sexual disorders.
The MHRA is inviting interested individuals including patients, patient representatives, health care professionals, researchers and organisations to contribute to the review.
In particular, the agency says it is interested in hearing opinions on the possible benefits and risks of isotretinoin treatment, the measures currently in place to minimise the risks and whether additional measures are needed to optimise its safe use.
All views provided will be reviewed by the MHRA Isotretinoin Expert Working Group (IEWG), an independent group of medical and scientific experts, as well as lay representatives and observers from relevant clinical organisations. The IEWG will report to the Commission on Human Medicines who will review the final recommendations.
The questions being addressed in the review are:
- What is your view, positive or negative, on the place of isotretinoin in the treatment of acne?
- What is your view of the risks associated with taking isotretinoin, particularly in relation to psychiatric effects, including effects on mood or mental health and or sexual dysfunction?
- What is your view on the measures currently in place to reduce the risks associated with isotretinoin?
- What further measures could be taken to optimise the safe use of isotretinoin and raise awareness of the potential risks?
Submission can be submitted here. The closing date for submissions is 2 February 2021.
