FOI release

Freedom of Information request on access to data from January - December 2020 with regards to ADRs reported as a result of hydroxychloroquine use for treatment of COVID-19 (FOI 21-702)

Published 29 December 2021

13th July 2021 FOI 21/702

Dear

Thank you for your Freedom of Information request dated 23rd June 2021, where you asked for information on the following:

• I would like to know if it is possible to get access to data from January - December 2020 with regards to ADRs reported as a result of hydroxychloroquine use for treatment of COVID-19.

The MHRA received a total of 5 UK spontaneous suspected Adverse Drug Reaction (ADR) reports in 2020 associated with hydroxychloroquine when indicated for COVID-19/coronavirus infection. Please be aware that it is not mandatory to provide the suspect drug indication when submitting a Yellow Card report to the MHRA, therefore the data provided only includes reports where the indication was specifically reported as COVID-19/coronavirus infection.

Yellow Card data is releasable to members of the public provided that patient and reporter confidentiality is maintained. Under the Freedom of Information Act (FOIA) 2000, the data for this request has been provided as category Ib. For this FOI, the line listings contain the fields below. Please note, any blank cells within the table are fields which have not been provided to us by the reporter.

Case number Patient Age Category (35-44, 45-54, 55-64, 65-74, 75-84, >85 years) Patient Gender Suspect drug(s) Suspect drug route(s) Treatment duration (days) Suspected Adverse Drug Reaction(s) Reaction onset first dose (days) Reaction outcome(s) Medical History

It is important to note that due to the nature of the Yellow Card Scheme, neither the incidence nor the prevalence of a reaction can be derived from these data, as neither the total number of reactions occurring, nor the number of patients using the drug is included in this data. Many factors influence the number of reports received. Reporting rates are influenced by the seriousness of the adverse drug reactions, their ease of recognition, the extent of use of a product, and may also be stimulated by promotion and publicity about a product.

Furthermore, it is also important to note that a report of a reaction does not necessarily mean that it has been caused by the drug in question. We encourage reporters to report suspected ADRs i.e. the reporter does not have to be sure of a causal association between the drug and the reactions – a mere suspicion will suffice. Therefore, reports submitted to MHRA may be true side-effects or they may be due to concurrent diagnosed or undiagnosed illness, other medicines, or they may be purely co-incidental events that would have occurred anyway in the absence of therapy.

As these data do not necessarily refer to proven side effects, you should refer to the product information which can be found here: Products for details on the possible side effects of this medicine.

I hope the information provided is helpful. The MHRA encourages the use of Yellow Card data however wishes to ensure that the data is studied and applied appropriately, and any conclusions/interpretations take into account the above information. For this reason, if you wish to use this information for a publication, we request that you engage with the MHRA during this process and provide a copy of the report.

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