Freedom of Information request on adverse drug reactions in COVID-19 patients treated with dexamethasone (FOI 21-414)
Published 28 June 2021
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6th May 2021 FOI 21/414
Dear
Thank you for your Freedom of Information (FOI) request where you requested information about adverse drug reactions in COVID-19 patients treated with dexamethasone.
Further to your request, please find attached the Drug Analysis Prints (DAP) relating to dexamethasone, inclusive of all brands reported. This DAP includes all UK spontaneous suspected ADR reports we have received for dexamethasone where the reporter has provided the indication for the drug as Covid-19. We have received a total of 18 reports in our database as of 4th of May 2021. When considering the attached DAP, it is important to be aware of the following points:
• It is important to note that drug indication is not a mandatory field on a Yellow Card form and is therefore not always provided. This may mean that there are reports for dexamethasone indicated for Covid-19 treatment but will not be included in our data search. • A reported reaction does not necessarily mean it has been caused by the drug, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of a drug, and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by the drug. Underlying or concurrent illnesses may be responsible and such events can also be coincidental. • It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular drug, and may be stimulated by promotion and publicity about a drug. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.
Any emerging evidence relating to possible risks associated with medicines, is carefully reviewed and, if appropriate, regulatory action would be taken if any serious risks were confirmed.
As the data provided in the print does not necessarily refer to proven side effects, you should refer to the product information which can be found here: https://www.medicines.org.uk/emc/ for details on the recognised possible side effects.
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.
Kind regards,
FOI Team Vigilance and Risk Management of Medicines Division Medicines and Healthcare Products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU