Published: March 2012

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IMMP Update: Varenicline (Champix) Monitoring

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Prescriber Update 33(1): 9
March 2012

The varenicline post-market monitoring project was contracted by Medsafe to the Intensive Medicines Monitoring Programme (IMMP).

Since monitoring began in 2007, the varenicline patient cohort has now reached its pre-specified cohort size and now contains over 12,000 patients.

A number of important interim findings have been published based on data from the IMMP including:

• information about the utilization of varenicline in New Zealand, including identification that some patients were not receiving the recommended 12 weeks of treatment¹
• analyses of the frequency of psychiatric adverse events^2,3
• a case series of cardiovascular events in patients taking varenicline⁴
• a case series of patients describing epistaxis and other bleeding events while taking this medicine⁵.

Final analysis of the varenicline data collected in this monitoring project is expected in mid-2012 and will be summarised in a future edition of Prescriber Update.

The IMMP has informed Medsafe that varenicline questionnaires will continue to be sent out after 30 June 2012. Please continue to return any outstanding questionnaires to the IMMP in the usual way.

Thank you to all healthcare professionals who have participated in this monitoring project and have provided valuable information about the safety and use of varenicline.

IMMP methodology can be used to investigate many different medicine safety issues. Organisations are able to contract IMMP studies to answer their research questions.

Healthcare professionals will be alerted to any new post-market monitoring projects as they are identified and initiated.

References

1. Harrison-Woolrych ML, Ashton J. 2010. Utilization of the smoking cessation medicine varenicline: an intensive postmarketing study in New Zealand. Pharmacoepidemiology and Drug Safety, 19(9): 949-953
2. Harrison-Woolrych ML. 2009. Varenicline and suicide: safety data from New Zealand. British Medical Journal, 339: b5654. DOI: 10.1136/bmj.b5654
3. Harrison-Woolrych ML, Ashton J. 2011. Psychiatric adverse events associated with varenicline: an intensive post marketing prospective cohort study in New Zealand. Drug Safety, 34(9): 763-772.
4. Harrison-Woolrych ML, Maggo S, Tan M, et al. 2012. Cardiovascular events in patients taking varenicline: a case series from intensive postmarketing surveillance in New Zealand. Drug Safety, 35(1): 33-43
5. Harrison-Woolrych ML, Harmark L, Tan M, et al. 2012. Epistaxis and other haemorrhagic events associated with the smoking cessation medicine varenicline: a case series from two national pharmacovigilance centres. European Journal of Clinical Pharmacology. DOI: 10.1007/s00228-012-1220-y.