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Revised: 2 May 2013

Intensive Medicines Monitoring Programme Report on Vareniciline (Champix)

Medsafe is releasing information from the Intensive Medicines Monitoring Programme (IMMP) study on the smoking cessation medicine, varenicline (Champix). This IMMP study was contracted by the Ministry of Health. This information is provided in the interests of transparency and to help healthcare professionals and consumers make informed decisions about using this medicine.

In Medsafe's opinion, the IMMP study findings reinforce the warnings published in the Champix data sheet as well as information previously provided to prescribers by Medsafe. As a result of this IMMP report, Medsafe and the Medicines Adverse Reaction Committee (MARC) have recommended that minor changes are made to the New Zealand data sheet for varenicline. Medsafe and the MARC consider that no additional regulatory actions are required at this time.

The most important safety concern associated with varenicline is adverse behaviour changes. Medsafe has previously provided advice to prescribers about monitoring consumers taking varenicline. That advice, also in the data sheet, recommends that consumers and their families should watch for unusual behaviour or thinking, agitation or depressed mood, suicidal thoughts or suicidal behaviour. Any consumer experiencing these changes should stop taking varenicline and contact a healthcare professional immediately.

Studies looking at adverse events from medicines used to stop smoking are complicated by the known psychiatric effects caused by nicotine withdrawal. Separating out the likely cause of symptoms associated with smoking cessation therapy is difficult and is the subject of continued study.

There are limitations to these types of studies in their ability to reliably estimate frequency or determine the likelihood that the medicine caused the adverse event. The IMMP study has provided supportive information that has been reviewed in conjunction with the findings of other studies.

Medsafe considers that the balance of benefits of taking varenicline outweigh the risks. However, individual consumers should make a decision of whether this medicine is right for them in conjunction with their prescriber.

The data being released includes:

Further information about Champix can be found in the data sheet (pdf 232KB 18 pages).

Further information about the IMMP can be found on the New Zealand Pharmacovigilance Centre website.

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