John Abrahams
14 Feb 2023 · Coroner Catherine McKenna · Manchester North
The coroner's concerns
1. psychiatric events
“The Commission for Human Medicine (CHM) established an lsotretinoin Expert Working Group (IEWG) in response to concerns about psychiatric events”
2. recommendations not implemented
“It is now over a year since the IEWG report was completed and the recommendations have still not been implemented”
3. adverse events reported
“In that time there have been 45 adverse lsotretinion events reported to the Medicines Healthcare products Regulatory Agency (MHRA) comprising of 81 psychiatric adverse events, one of which was an attempted suicide”
4. implementation group not meeting
“a second working group is required to consider how to implement the IEWG recommendations and that this group has yet to meet”
Responses
2023-0058-Response-from-Department-of-Health-and-Social-Care.pdf ↗· Department of Health and Social Care
Stated action · 12 May 2023
“the Isotretinoin Implementation Working Group mentioned in letter has met three times, with the third meeting occurring on 12 May 2023”
2023-0058-Response-from-Medicines-and-Healthcare-products-Regulatory-Agency-1.pdf ↗· Department of Health and Social Care
Stated action · mid May 2023
“The Implementation Working Group has had two meetings in March 2023 and is making good progress with a further meeting planned in mid May 2023.”
2023-0058-Response-from-Medicines-and-Healthcare-products-Regulatory-Agency.pdf ↗· Department of Health and Social Care
Stated action · mid-May 2023
“The Implementation Working Group has had two meetings in March 2023 and is making good progress with a further meeting planned in mid-May 2023.”