Freedom of Information request about UK spontaneous adverse drug reaction reports concerning e-cigarettes (FOI-21-267)
Published 28 May 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-12-april-2021/freedom-of-information-request-about-uk-spontaneous-adverse-drug-reaction-reports-concerning-e-cigarettes-foi-21-267
As per request 3, please find enclosed all UK, spontaneous adverse drug reaction reports concerning e-cigarettes up to and including 25/03/2021 containing 258 reports.
When assessing the data attached, it is important to note that the inclusion of a report on our ADR database does not necessarily mean that the events described were caused by the drug, only that the reporter had a suspicion it may have, or it had a close temporal relationship to the administration of the medicine. It is important to note that symptoms occurring after a medication is taken are not always caused by the medication itself; underlying illnesses and other conditions may be responsible. In any individual case it is very difficult to determine whether the drug was causal, contributory or simply coincidental.
The number of reports received should not be used as a basis for determining incidence of a reaction as neither the total number of reactions occurring, nor the number of patients using the drug is known. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a drug, and may be stimulated by promotion and publicity about a drug. Furthermore, the data provided should not be used in any way to attempt to identify the original reporter of the Yellow Card nor should the data be used for disciplinary or audit purposes.
The MHRA encourages the use of Yellow Card data however wishes to ensure the correct interpretation is placed upon the data. For this reason, if you wish to use this information for a publication, we request that a copy of the report be sent to the MHRA ([email protected]) for approval.
Data from Yellow Card reports received relating to suspected side effects to nicotine-containing e-cigarettes can also be viewed on the e-cigarette Analysis Print. Please see accompanying guidance document explaining how this data should be interpreted.