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<p>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.</p><p>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.</p><p>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:</p><p> </p><table><tbody><tr><td> </td><td><p>Total
Serious Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>297</p></td></tr><tr><td><p>Nicotine
Replacement therapy</p></td><td><p>75</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>5</p></td></tr></tbody></table><p>
</p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p><p> </p>
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