FOI release

Freedom of Information request on deaths occurring in association with isotretinoin (FOI 22/455 )

Published 1 June 2022

FOI 22/455

10th March

Dear ,

Thank you for your information request, dated 8th February 2022, where you asked for information on deaths occurring in association with isotretinoin.

Please find responses to your questions below.

How many families have reported serious side effects including suicides without you ever hearing from the prescribing dermatologist or any other medical professionals like GP’s, endocrinologists, psychiatrists, coroners etc?

The Yellow Card scheme relies on voluntary reporting from healthcare professionals and members of the public. In some instances, the MHRA may receive information from multiple sources which results in duplicate reports.

I can confirm that the MHRA collects data on whether the report was reported by a healthcare professional or member of the public. However, in order to identify and verify if a report was received by a member of the family and also a healthcare professional, we would need to manually review each case on our system. Section 12 of the FOI Act specifies that a public authority may refuse requests where the cost of dealing with them would exceed the appropriate limit, which for central government is set at £600. This represents the estimated cost of one person spending 24 working hours in determining whether the department holds the information, locating, retrieving and extracting the information. We consider that reviewing these cases would take longer than 24 hours to complete.

If the suicide of an Isotretinoin patient comes to your attention via a media report but not by the family or any other person, will you still investigate the death and add it to the Yellow Card Data?

It is a responsibility of the marketing authorisation holder (MAH) for a medicine to regularly screen the internet or digital media. This may include but is not limited to websites, internet forums and social media. If the MAH is made aware of a report of a suspected adverse reaction described by non-company sponsored digital media, the details are assessed to determine whether it meets the minimum level of criteria for reporting as an ADR report to the MHRA. The MHRA do not actively screen digital media for reports of suspected adverse reactions.

If the MHRA are directly made aware of a report in the media, it is assessed to see whether it met the minimum level of information for a valid ADR report (an identifiable patient, a suspect medicine, a suspected adverse reaction, and an identifiable reporter) and added to the database as necessary.

Please confirm that the Death of David Perez was never investigated or included in the yellow card data until his mother reported it 20 years post the suicide? Is it true that the prescribing dermatologists, Dr David Shuttleworth, never reported David’s death despite knowing about it? We are not able to comment on whether data on particular individuals are held within the Yellow Card database. Any information on individuals within the Yellow Card system is held in strict confidence. Section 41 of the FOI Act specifies that a public authority may refuse requests where the information was provided to the public authority in confidence.

If an Isotretinoin death has been reported to the MHRA but the death is recorded as a suicide not linked to Isotretinoin by a coroner - will the death/suicide be excluded from the Yellow card data?

An individual Yellow Card report can only be removed from the Yellow Card database by the original reporter. This may include reasons where the case was reported in error or upon receipt of further information the patient did not receive the drug. However, a death which was not linked to a suicide by a Coroner would not be reason to remove the report and the report would remain valid on our database.

If 40,000 prescriptions of Isotretinoin are issued each year - would that equate to 40,000 patients per year of would each patients receive 1,2 or more prescriptions each?

Information on the usage of a medicine can be presented in a number of ways. The number of prescriptions would indicate the number of times that the medicine was dispensed from a pharmacy. For a course of isotretinoin, each patient would be likely to receive a number of prescriptions depending on the length of the course.

Information can also be presented in terms of sales, for example the number of tablets sold. For medicines such as isotretinoin that are mostly dispensed in hospitals rather than community pharmacies, this is the only data that can be readily obtained. This sales data is then sometimes converted into an estimate of the number of patients treated, by making assumptions about the average dose of medicine being taken and length of the course.

21 Isotretinoin deaths were reported in 2020 and 2021(end Sept) - of these only 9 included the date of death. Does this mean that only these 9 deaths were included in the yellow card data for the public to view?

Between the 1 January 2020 and the 30 September 2021, the MHRA has received 21 UK spontaneous suspected ADR reports of isotretinoin associated with a fatal outcome. 9 of these reports state a date of death. All reports are included in the Yellow Card data via the iDAPs irrespective of whether a date of death is provided. Where possible the MHRA have followed up to try to determine the date of death.

Please confirm that one Isotretinoin suicide was reported between Sept 2021 and December 2021 - did the death occur in 2021 and was there enough information to include it in the yellow card data for the public to view.

One UK spontaneous suspected ADR report of isotretinoin with a fatal outcome was received between the 1 September 2021 and 31 December 2021. This case was identified as a duplicate report and was merged into the original Master report which was first received in 1998. This report will no longer be accounted for in the number of reports received in 2021.

How many Isotretinoin deaths have been reported to the MHRA but not been included in the yellow card data for lack of information?

One report of a fatal reaction was invalidated due to a lack of a patient identifier. The report was originally reported by the Marketing Authorisation Holder. Please note that this report is stored on our database but is not included in the valid reports published via the iDAPs.

Coroner, Prof Paul Marks stated in 2017 that he would be making an official report following Goerge Hessay’s suicide. The coroner took into consideration that George’s father recognised that George experienced mood changes during Isotretinoin treatment - George’s suicide was associated with Isotretinoin and cyber bullying? Was George’s suicide listed in the yellow card data for members of the public to view? Did the MHRA receive a report from Prof Marks?

We are not able to comment on whether data on particular individuals are held within the Yellow Card database. Any information on individuals within the Yellow Card system is held in strict confidence. Section 41 of the FOI Act specifies that a public authority may refuse requests where the information was provided to the public authority in confidence.

Coroners’ Prevention of Future Deaths reports are publicly available from https://www.judiciary.uk/subject/prevention-of-future-deaths/. We can confirm that the MHRA did not receive a Prevention of Future Deaths report relating to George Hessay.

Was Georges death investigated and did the MHRA consider that George’s erratic behaviour might be related to Isotretinoin treatment?

All reports received by MHRA where a medicine has been associated with a fatal outcome are routinely followed up for additional details, including requesting a copy of the post mortem if available. Investigation of deaths is within the remit of the coroner, rather than MHRA. If the report was submitted by a member of the public, we may ask if we can contact a relevant healthcare professional for further details if appropriate. However, not all ADR reports received by the MHRA are suitable for follow up; some reporters request they do not wish to be contacted again by the MHRA and, other reports are complete and contain all the necessary information to enable assessment of the case. In addition, for reports received indirectly from pharmaceutical companies, follow-up is conducted by the MAH for that product as part of their Pharmacovigilance responsibilities.

We are not able to comment on whether data on particular individuals is held within the Yellow Card database. Any information on individuals within the Yellow Card system is held in strict confidence. Section 41 of the FOI Act specifies that a public authority may refuse requests where the information was provided to the public authority in confidence.

If you have a query about the information provided, please reply to this email.

Yours sincerely,

FOI Team

Vigilance & Risk Management of Medicines

MHRA

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