Safety Information

Revised: 28 May 2014

Early Warning System - Monitoring Communication

Medsafe emphasises that patients should NOT stop using any medicine or medical device subject to a monitoring communication. If you have any concerns with a medicine or medical device you are using, please contact your health professional. A monitoring communication does not mean that the medicine or medical device causes an adverse event.

M² logo Champix (varenicline) and a possible interaction with alcohol based on post-marketing reports

17 June 2013

Medsafe has identified a signal of a possible interaction between varenicline and alcohol following a review of the latest Champix Periodic Safety Update Report.

Varenicline has been placed on Medsafe's medicine monitoring scheme (M² logo) because we are seeking additional information.

Products Affected

Champix (varenicline) is indicated as an aid to smoking cessation and is distributed by Pfizer.

Additional Information

In New Zealand, the Centre for Adverse Reactions Monitoring (CARM) has received five reports involving patients taking varenicline who also consumed alcohol since September 2009. The Centre for Adverse Reactions Monitoring (CARM) classified one of these reports as being an interaction. This report involved a behavioural change.

Medsafe is seeking further information to assess whether this is a true interaction or is a coincidental event.

Advice on how to use Champix

Advice on how to take this medicine and possible side effects can be found in the consumer medicine information (CMI) and data sheet.

Download the consumer medicine information for Champix (PDF 140KB, 6 pages)
Download the data sheet for Champix (PDF 230KB, 18 pages)

Regulator Actions

Medsafe is continuing to monitor reports of adverse events to varenicline involving alcohol.

Reporting

Consumers and healthcare professionals are encouraged to send reports of suspected adverse reactions to the Centre for Adverse Reactions Monitoring (CARM).

Medsafe cannot give advice about an individual's medical condition. If you have any concerns about a medicine you are taking Medsafe encourages you to talk to your healthcare professional.

How to report an adverse reaction

Update to Original Communication

28 May 2014

This safety concern was presented to the Medicines Adverse Reactions Committee (MARC) at the March 2014 meeting. The Committee recommended updates to the Champix data sheet to include information about occasional reports of adverse neuropsychiatric events or reduced alcohol tolerance.

Read the MARC meeting minute