Written question asked by David TC Davies (Conservative) on Friday, 26 September 2014, in the House of Commons. It was due for an answer on Wednesday, 15 October 2014 (named day). It was answered by Jane Ellison (Conservative) on Wednesday, 15 October 2014 on behalf of the Department of Health.
Smoking
- Question
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To ask the Secretary of State for Health, pursuant to the Answer of 4 September 2014 to Question 206979, with reference to the finding that the number of serious suspected adverse drug reaction reports arising from use of nicotine replacement therapies and varenicline is significantly higher than that arising from the use of e-cigarettes, if his Department will require more prominent health warnings to be displayed for those drugs than for e-cigarettes.
- Answer
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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.
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.
Total Number of Reports
Varenicline
3
Nicotine Replacement therapy
8
E-Cigarettes
0
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.
The MHRA does not hold data on the number of fatalities associated with nicotine replacement therapies varenicline or e-cigarettes in other countries.
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.
Secondary information
- Type
- Written question
- Reference
- 209716
- Session
- 2014-15
- Related items
- Grouped for answer
- Yes
- Subjects
- Smoking Side effects Nicotine replacement therapy Electronic cigarettes
- Contains statistics
- Yes
- Link
- View this Written question on www.parliament.uk
Librarians' tools
- Timestamp
- 2022-10-05 12:05:44 +0100
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- http://data.parliament.uk/writtenparliamentaryquestion/commons/2014-15/209716
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