News Release Page Title

12 June 2001

NEW GUIDANCE ISSUED TO DOCTORS ON THE PRESCRIBING OF ZYBAN

The Committee on Safety of Medicines (CSM) has announced a change to the prescribing regime, and strengthened warnings for doctors prescribing the smoking cessation aid Zyban.

Zyban is a nicotine free treatment licensed in June 2000, for the cessation of smoking in individuals motivated to give up. Between June 2000 and January 2001, 21,361 prescriptions were issued here in the community.

The CSM has reviewed all current evidence and advised that:

  1. The prescribing regime should be amended to delay the increase in dose from day 4 to day 7 of treatment in order to give more time for drug levels to stabilise. Currently patients taking Zyban double their dosage on day 4 of treatment.

  2. Existing warnings for prescribers relating to risk factors for seizures should be strengthened to emphasise that Zyban should only be used in patients with these factors if there are compelling clinical reasons.

Professor Breckenridge, Chair of the Committee on the Safety of Medicines, said:

"As with all newly licensed medicines, Zyban has been carefully monitored under an intensive monitoring scheme. The changes to the prescribing regime and the strengthened warnings will help to further reduce the number of people who experience adverse reactions whilst taking Zyban

The Committee on Safety of Medicines and the Medicines Control Agency, in conjunction with other European Regulatory Authorities, are taking this action and will be keeping the safety of Zyban under close, constant scrutiny."

Smoking is the single greatest cause of premature death, and is responsible for nearly 3,000 deaths here each year. Zyban has been shown to increase the chances of stopping smoking compared with other means. The benefits of this for the individual in terms of reduction of risk of cardiovascular disease and cancer are well recognised.

A letter has been sent to all GP’s, pharmacists and other health professionals here to advise them of the changes. Any patient who is currently taking Zyban on the original dosage and continues to feel well should continue to take the drug. While you are taking Zyban it is very important to tell your doctor or pharmacist before taking any new medicines. Patients who have any concerns should contact their GP or pharmacist.

Media enquiries should be directed to Gary Tempest on 0207 210 5821

Non-media enquiries should be directed to

Dr Williams at the Medicines Control Agency on 0207 273 0369.

NOTES TO EDITORS

  1. A copy of the Patient Information Leaflet is attached.

  2. The dosage regime prior to advice from Committee on Safety of Medicines was one tablet per day for 3 days then 2 tablets per day from day 4 onwards.

  3. As of 24 May 2001 over 5,000 adverse reports have been received regarding Zyban of which 40 have been associated with a fatal outcome. About 2% of adverse reports are associated with a fatal outcome. For Zyban, the proportion of reports that is fatal is much lower – less than 1%. The Committee on Safety of Medicines considers that the reports received are in line with the known safety profile of Zyban.

  4. The primary responsibilities of the Medicines Control Agency are to protect and promote high standards of public health through the regulation of the quality, efficacy and safety of human medicines. Its work includes: the regulation of clinical trials, licensing of medicines and monitoring their safety once on the market, investigating possible hazards and taking appropriate action to minimise the risk to users, inspection of premises manufacturing medicines and taking enforcement action if activities fall outside the law.

  5. The Committee on Safety of Medicines is an independent expert advisory committee established under Section 4 of the Medicines act 1968 to advise the Licensing Authority on questions of safety, quality and efficacy of medicines for human use. The Committee also advises the Licensing Authority on the collection and interpretation of data on adverse drug reactions.

  6. The yellow card adverse drug reaction reporting scheme enables health professionals, including doctors and pharmacists to report suspected adverse reactions to medicines to the Medicines Control Agency and Committee on Safety of Medicines.