FOI release

FOI 21/131 – Coroner’s Cases – Enquiry regarding Isotretinoin and concerns raised

Published 24 March 2021

Thank you for your email dated 1st February 2021, where you asked for information regarding coroner’s cases. You requested the following information:

• What actions did the MHRA take following Dr Dean raising his concerns with them? (https://www.eadt.co.uk/news/coroner-asks-for-review-of-acne-drug-roaccutane-after-photographer-2237278)

• How many Coroner have raised concerns about Isotretinoin and asked for further investigation?

Please see below our response to your request which addresses each of your points in turn.

What actions did the MHRA take following Dr Dean raising his concerns with them?

The MHRA can confirm that correspondence was received from Dr Dean relating to isotretinoin. This correspondence cannot be released under FOI as the coroner’s report and associated replies are owned by the Coroner and may be published by the Coroner on the judiciary website. https://www.judiciary.uk/related-offices-and-bodies/office-chief-coroner/https-www-judiciary-uk-subject-community-health-care-and-emergency-services-related-deaths/

Reports of psychiatric disorders, including cases of suicidal ideation and suicide have been reviewed on a number of occasions by the MHRA prior to Dr Dean’s correspondence. The issue of possible psychiatric side effects including the risk of suicide has been reviewed regularly in periodic safety update reports at the request of the MHRA, as the leading country for isotretinoin prior to the UK’s exit from the EU. Following the correspondence in 2016, the UK triggered a European Article 31 referral procedure (major safety review) requesting the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency to review the risk minimisation in place for the oral and topical retinoids, including isotretinoin, and ensure that the risks associated with adverse teratogenic effects and neuropsychiatric disorders were adequately addressed. The MHRA played an active part in the referral process. The public assessment report is available here:

https://www.ema.europa.eu/en/documents/referral/retinoid-article-31-referral-prac-assessment-report_en.pdf

Due to ongoing concerns, the Commission on Human Medicines (CHM) endorsed proposals for an independent review of the safety of isotretinoin by the Isotretinoin Expert Working Group in September 2019. The ongoing review is examining the evidence for the possible risks of psychiatric adverse reactions, including suicide, and sexual dysfunction, and whether further action is needed to minimise or raise awareness of these risks in the UK. https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects

The MHRA has also published a number of relevant articles in Drug Safety Update since 2015 aiming to inform prescribers and patients about this risk:

26 October 2017 – an article on sexual dysfunction which included a reminder of the risk of mood disorders, including very rarely death by suicide. https://www.gov.uk/drug-safety-update/isotretinoin-roaccutane-rare-reports-of-erectile-dysfunction-and-decreased-libido

19 June 2019 – an article summarising the outcomes of the EU Referral on retinoid medicines which included advice about neuropsychiatric disorders. https://www.gov.uk/drug-safety-update/oral-retinoid-medicines-revised-and-simplified-pregnancy-prevention-educational-materials-for-healthcare-professionals-and-women

26 August 2020 – a reminder of important risks and precautions, including the risk of psychiatric reactions, and announcement of the Expert Working Group convened to review the safety of isotretinoin, including psychiatric adverse events. https://www.gov.uk/drug-safety-update/isotretinoin-roaccutane-reminder-of-important-risks-and-precautions

How many Coroner have raised concerns about Isotretinoin and asked for further investigation?

The MHRA began logging coroners’ letters in a central database in 2014. Since 2014, two coroners, including Dr Dean, have written to the MHRA about isotretinoin. Of these, one (Dr Dean) requested further investigation; the other was for information only.

I hope the information provided is helpful, but if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address. Yours sincerely,

FOI Team, Vigilance and Risk Management of Medicines Division