Freedom of Information request (FOI 22/847)
Published 17 January 2024
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FOI 22/847
12th August 2022
Dear
Further to your request, I can confirm that we have received a total of 295 UK, spontaneous suspected ADR reports for E-cigarettes up to and including 02/08/2022. Please find the attached Drug Analysis Print (DAP) for details of the reported reactions and refer to the enclosed information sheet for guidelines on how to interpret the DAP.
Please note that the total number of reactions in the table will not be equal to the total number of unique reports as one report may contain more than one reaction.
When considering these attached ADR data, it is important to be aware of the following points:
- The likelihood of experiencing an adverse reaction when using an e-cigarette cannot be estimated from the information in the Analysis Print. This is because we have limited information about how many people have used the e-cigarette without experiencing a reaction.
- Reporters are asked to submit Yellow Card reports even if they only have a suspicion that the e-cigarette may have caused the adverse reaction. The existence of an adverse reaction report on an Analysis Print does not necessarily mean that the e-cigarette has caused the reaction.
- It may be difficult to tell the difference between something that has occurred naturally and an adverse reaction. Sometimes reactions can be part of an underlying condition rather than being caused by the e-cigarette.
- Many factors have to be considered when assessing whether an e-cigarette has caused a reported adverse reaction. When monitoring the safety of these products, MHRA staff carry out careful analysis of these factors.
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