Research and analysis

Report of the Commission on Human Medicines Isotretinoin Expert Working Group

Report of the Commission on Human Medicines (CHM) Isotretinoin Expert Working Group and plain-language summary of the recommendations.

From:
Commission on Human Medicines and Medicines and Healthcare products Regulatory Agency
Published
26 April 2023

Documents

Report of the Commission on Human Medicines Isotretinoin Expert Working Group

PDF, 1.14 MB, 122 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Isotretinoin expert safety review – a plain-language summary of the recommendations

PDF, 241 KB, 19 pages

This file may not be suitable for users of assistive technology.

Request an accessible format.
If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

This report of the Commission on Human Medicines Isotretinoin Expert Working Group outlines the data considered, the review process and the resulting recommendations of the review of psychiatric and sexual side effects suspected to be associated with the treatment for severe acne, isotretinoin.

A plain-language summary of the recommendations is also available for anyone who wants to understand the recommendations arising from the expert safety review.

For further information about the review and implementation of the recommendations, see the MHRA website.

Published 26 April 2023