To ask the Secretary of State for Health
(1) what guidelines have been given to health authorities for the prescribing of the anti-smoking drug Zyban; and which health authorities allow GPs to prescribe this drug;
(2) if he will calculate the number of people who have been prescribed the anti-smoking drug Zyban since its release on prescription basis; and how many deaths have been attributed to the use of Zyban;
(3) what changes have been made to the recommended dosage of Zyban by the manufacturers GlaxoSmithKline during the last 12 months; and for what reasons these alterations were made;
(4) what assessment he has made of the effectiveness and safety of Zyban in the treatment of people addicted to smoking; and if he will make a statement.
Since Zyban (bupropion) was marketed in the United Kingdom in June 2000, at least 440,900 prescriptions of Zyban have been dispensed, based on the prescription cost analysis (PCA) data for England.
To date, there have been 53 reports to the Committee on Safety of Medicines (CSM)/Medicines Control Agency (MCA) of suspected adverse reactions in relation to Zyban with a fatal outcome. The contribution of Zyban to these fatal cases is unproven and in the majority of cases the individual's underlying condition may provide an alternative explanation. In 14 of these reports the individual was not taking Zyban at the time of death. Smoking itself is the single greatest cause of premature deaths in the UK and is responsible for 120,000 deaths per year, which is equivalent to more than 13 people an hour.
Zyban has been authorised in 14 European member states via the mutual recognition procedure. At the time of licensing our independent expert scientific advisory body, the CSM, advised that Zyban met appropriate standards of quality, safety and efficacy to justify its licence for use as an aid to smoking cessation in combination with motivational support in nicotine- dependent patients.
Since marketing, the safety of Zyban has been closely monitored by the MCA/CSM, particularly the accumulating evidence from spontaneous reports of suspected adverse drug reactions received in association with its use. The CSM has advised that the balance between the effectiveness of Zyban in helping people to stop smoking, and the health benefits that this brings, with the risk of adverse effects remains favourable.
Guidance on prescribing and use of Zyban is provided in the authorised Summary of Product Characteristics for health professionals and Patient Information Leaflet. These documents provide information on use of Zyban, contraindications, warnings and possible adverse effects. Key prescribing information is also included in the British National Formulary which is sent by the Department to doctors and pharmacists.
Zyban was made available on national health service prescription in June 2000 in all health authorities. Since then a number of communications have been issued to health professionals. In March 2001 the MCA and CSM reminded general practitioners and health professionals in smoking cessation clinics about the safety profile of bupropion and provided information on safe prescribing, in particular predisposing factors for seizures. This information was distributed to doctors and pharmacists in the MCA/CSM drug safety bulletin "Current Problems in Pharmacovigilance".
In May 2001, the CSM issued new guidance (strengthened warnings particularly about potential interactions with other medicines) and advised a slower increase in the dose of Zyban in order to minimise the risk of side effects especially seizures (the lower 150mg dose should be prescribed for the first six days, increasing to 150mg twice daily on day seven rather than day four). This new guidance was issued in order to allow more time for the drug levels to stabilise, to help minimise the risk of adverse reactions, particularly seizures.
The Department provided information to all doctors concerning the safety of Zyban, via an article in the Chief Medical Officer's Update 30 (May 2001), entitled "Safety of Zyban as an aid to smoking cessation". A copy of the CMO's Update 30 can be found in the Statistics Section, in the Library. Updated information on the safety profile of Zyban can also be found on the MCA website.