Freedom of Information request on the death reported following isotretinoin treatment in 2020 and 2021 (FOI 21/1032)
Published 27 April 2022
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6th October 2021
FOI 21/1032
Dear
Thank you for your information request, dated 9th September 2021, where you asked for information on deaths occurring in association with isotretinoin treatment in 2020 and 2021.
I am pleased to provide you with the information requested, see below.
The MHRA received 12 reports of death associated with isotretinoin in 2020 and 9 reports in 2021, as of the 12th of Sept 2021. Of these 21 reports, 9 included the date of death. Of these, none occurred in 2020 and one occurred in 2021.
No reports have been deleted. Reports identified as duplicates of existing cases are merged so that any new details are captured and the information about the case is as complete as possible. Each individual patient has one Yellow Card reference number.
The MHRA has received a number of reports in the past 2 years that have been submitted following media coverage of deaths associated with isotretinoin. Pharmaceutical companies submit reports based on media coverage to MHRA as part of their due diligence processes. Such reports may relate to previously known cases, but many are lacking in detailed information. Cases are only merged when there is sufficient information regarding the patient, their treatment and side effects.
The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.
If you have a query about the information provided, please reply to this email.
Yours sincerely,
FOI Team
Vigilance & Risk Management of Medicines