§ Dr. FoxTo ask the Secretary of State for Health what advice he has received in the last six months on the safety of bupropion (Zyban). [12729]
§ Ms Blears[holding answer 6 November 2001]: Since the marketing of bupropion (Zyban) in June 2000, my right hon. Friend the Secretary of State has been kept informed by the Medicines Control Agency (MCA) and the Government's independent expert scientific advisory body, the Committee on Safety of Medicines (CSM), on matters relating to its safety.
In the last six months this has included the following CSM advice issued on 31 May 2001, the purpose of which was to minimise the risk of adverse effects especially seizures:
- (i) The dosing regimen should be amended to delay the increase in dose (from day four to day seven of treatment) in order to give more time for drug levels to stabilise.
- (ii) Existing warnings relating to the other risk factors for seizure should be strengthened to emphasise that Zyban should only be used in patients with these factors if there are compelling clinical reasons.
The CSM has continued to review 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. This balance is considered to remain favourable. There is some indication that the latest advice issued by CSM has helped to further improve the safe use of Zyban, since the rate of reporting of suspected 360W adverse reactions in the United Kingdom has decreased since then. The CSM will continue to monitor its safety record of Zyban closely.