19 October 2001 News Update

ZYBAN PRESCRIBING CHANGES

Bupropion is now recommended for use only after other smoking cessation treatments have been tried and failed.

The recommendation from the Medicines Adverse Reactions Committee (MARC) comes following a review of adverse effects to bupropion (Zyban).

Ministry of Health senior medical advisor Dr Stewart Jessamine said the committee is advising prescribers that Zyban should be considered only as a secondary intervention and as part of a smoking cessation programme.

"Zyban should only be prescribed after a person has unsuccessfully tried to stop smoking with other smoking cessation treatments, including nicotine replacement therapy," he said.

The Centre for Adverse Reactions Monitoring (CARM) recorded 218 reports of adverse reactions to Zyban in New Zealand, up to August this year. However, in many cases the association of the drug has been difficult to establish, as many of the reported events may have been symptoms of nicotine withdrawal.

Evidence suggests that New Zealand prescribers are using the product in a responsible manner, and that the nature and number of reactions in New Zealand follow a pattern similar to Australia and the United Kingdom.

Adverse reactions reported to CARM include rash, itch, insomnia, depression, anxiety, tremor, and headache. Although not always serious, the reactions were severe enough for most patients to stop treatment.

Stewart Jessamine said that, despite the reports, the benefits of bupropion, used appropriately, still outweigh the risks.

Smoking is still the single greatest cause of premature death in New Zealand and worldwide evidence indicates the benefits of stopping smoking outweigh the risk of bupropion adverse events.

GlaxoSmithKline (GSK) medical director Ian Griffiths emphasises that the secondary intervention stance is only a recommendation. He said that company data supports the safety and efficacy of Zyban, and this is reflected in the fact that it is registered as a first line smoking cessation treatment in about 50 countries worldwide.

It also offers an alternative for patients such as those with cardiovascular disease, who can't use NRT, he said.

"In effect, the committee's recommendation probably supports current practice in New Zealand, because of the subsidised nicotine replacement therapy scheme - most people will try the NRT scheme first because of the minimal cost," said Ian Griffiths.

GSK is discussing the MARC recommendation with Medsafe, particularly in relation to the Zyban data sheet. However, Ian Griffiths said that GSK is not planning to make any changes to the data sheet, because they have data to support the current information.

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