Health written question – answered on 4th September 2014.

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Photo of David Davies David Davies Chair, Welsh Affairs Committee

To ask the Secretary of State for Health how many serious health events have been recorded per thousand (a) e-cigarette users, (b) users of nicotine replacement therapies and (c) users of the Champix form of varenicline in the last year.

Photo of Jane Ellison Jane Ellison The Parliamentary Under-Secretary of State for Health

Reports of ‘suspected’ adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines through the spontaneous reporting scheme; the Yellow Card Scheme. The scheme collects ADR reports from across the whole United Kingdom and includes all medicines, including those from prescriptions, over-the-counter or general retail sales. Reports are also received for herbal medicines and other unlicensed medicines.

There is unknown and a variable level of under-reporting to the Yellow Card Scheme meaning that data collected cannot be used to calculate incidence, as such we cannot provide the number of serious health events per thousand. We are unable to calculate this incidence because neither the total number of reactions occurring in the population, nor the number of patients using the drug is known.

The following table shows the total number of serious UK spontaneous ‘suspected’ ADR reports received by the MHRA between 23 July 2013 and 22 July 2014 broken down for E-Cigarettes, Nicotine Replacement Therapies (excluding E-Cigarettes) and Varenicline:

  Total Serious Reports
Varenicline 297
Nicotine Replacement therapy 75
E-Cigarettes 5

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