HC Deb 24 June 2004 vol 422 cc1560-1W
Mr. Boris Johnson

To ask the Secretary of State for Health (1) what guidance he has given to general practitioners regarding possible side effects of use of the drug Zyban; [179181]

(2) if he will make a statement on yellow card reports received in connection with use of the drug Zyban. [179182]

Ms Rosie Winterton

Guidance on prescribing and use of Zyban, including possible side effects, is provided in the authorised summary of product characteristics for health professionals and patient information leaflet. Key prescribing information is also included in the British National Formulary which is sent by the Department to doctors and pharmacists within the national health service.

Since marketing, the safety of Zyban has been closely monitored by the Committee on Safety of Medicines (CSM). The CSM has looked at the accumulating evidence from Yellow Card reports of suspected adverse drug reactions (ADRs). received in association with its use. In accordance with their advice, a number of steps have been taken to optimise the safe use of Zyban and to minimise the risk of side effects, particularly seizures. This includes advice to general practitioners and smoking cessation clinics, which was issued in March 2001, reminding them of the safety profile of Zyban and of information posted, on the CSM website.

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, 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. Since this guidance was issued, the reporting rate of suspected ADRs has fallen significantly.

A total of 8,466 reports of suspected adverse reactions have been received via the Yellow Card scheme in the United Kingdom. The most commonly reported reactions are urticaria, insomnia, rash, headache, dizziness and nausea, which are recognised reactions and are listed in the product information provided to prescribers and patients. It is important to note that these suspected reactions are not necessarily caused by the drug and may relate to other factors such as nicotine withdrawal, other illnesses or other medicines taken concurrently.

The safety of Zyban continues to be monitored closely by the Medicines and Healthcare Regulatory Authority/CSM. The CSM has advised that the balance of the effectiveness of Zyban in helping people to stop smoking, and the health benefits that this brings, compared with the risk of adverse effects remains favourable.