PARLIAMENTARY WRITTEN QUESTION
Isotretinoin: Side Effects (28 March 2023)

To ask the Secretary of State for Health and Social Care, with reference to the review by the Medicines and Healthcare products Regulatory Agency on Isotretinoin: an expert review of suspected psychiatric and sexual side effects, if he will make an assessment of the potential merits of providing redress for people who have experienced severe side effects from isotretinoin.

Asked by:
Andrew Western (Labour)

The Medicines and Healthcare products Regulatory Agency (MHRA) obtains independent advice from the Commission on Human Medicines (CHM). The Isotretinoin Expert Working Group was convened by CHM to evaluate the latest data on risk of psychiatric adverse reactions and sexual dysfunction suspected to be associated with the use of isotretinoin and to consider whether regulatory action is required to minimise risks or raise awareness of the risks. The report of this review will be published shortly, and more information on the working group is available at the following link:

https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects

The matter of redress sat outside the scope of the expert review and is also outside the remit of MHRA. Our primary focus currently is on improving future medicines and medical devices safety.

Answered by:
Will Quince (Conservative)
17 April 2023