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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 United Kingdom and includes all medicines, including those
from prescriptions, those bought over-the-counter in pharmacies or general retail
sales outlets. Reports are also received for herbal medicines and other unlicensed
medicines.</p><p> </p><p> </p><p> </p><p>The table below shows the total number of
UK spontaneous ‘suspected’ ADR reports in association with school children (ages 5-16),
received by the MHRA up to 30 September 2014 broken down for E-Cigarettes, Nicotine
Replacement Therapies (excluding E-Cigarettes) and Varenicline.</p><p> </p><p> </p><p>
</p><table><tbody><tr><td><p> </p></td><td><p>Total Number of Reports</p></td></tr><tr><td><p>Varenicline</p></td><td><p>3</p></td></tr><tr><td><p>Nicotine
Replacement therapy</p></td><td><p>8</p></td></tr><tr><td><p>E-Cigarettes</p></td><td><p>0</p></td></tr></tbody></table><p>
</p><p> </p><p> </p><p>There is unknown and variable level of under-reporting to the
Yellow Card Scheme meaning that data collected cannot be used to calculate incidence.
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>
</p><p> </p><p> </p><p>The MHRA does not hold data on the number of fatalities associated
with nicotine replacement therapies varenicline or e-cigarettes in other countries.</p><p>
</p><p> </p><p> </p><p>The requirements for medicines labelling and patient information
are set out in European and national legislation. Provisions already exist for a series
of warning statements to appear on the packs of nicotine replacement therapy medicines.
All medicines are also accompanied by a patient information leaflet which includes
detailed information on the safe and effective use of the product and warnings about
known adverse effects.</p><p> </p><p> </p><p> </p>
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