4 December 2008

The National Prescribing Service Limited (NPS) advises people taking the quit-smoking drug varenicline (marketed in Australia as Champix) to speak to their GP or pharmacist or contact Medicines Line if they are concerned about possible side effects.

In its December newsletter, the Adverse Drugs Reactions Advisory Committee (ADRAC) said it had received a number of adverse reaction reports for varenicline, which included depression, aggression, agitation, abnormal dreams, insomnia, hallucination and anger, as well as reports of suicidal or self-injurious ideation or behaviour.

'As is often the case with any new medicine, it is only once it has been on the market for a while and more people use it that unknown side effects come to light,' NPS CEO, Lynn Weekes, said.

'Varenicline is still a useful medicine for those who have been unsuccessful with other smoking-cessation products and methods. While these side effects are serious and should be taken into consideration before starting this medicine, the number of reported adverse events indicates only a small percentage of patients have been affected.

'If you think you have experienced a side effect, speak to your GP or pharmacist, or call Medicines Line on 1300 888 763, which is an information service operated by a pharmacist for people who have queries about their medicines.

'If you are caring for someone who is taking varenicline, keep an eye on their behaviour, especially if they have a history of psychiatric illness.'

Prescribers are reminded to discuss possible side effects of varenicline with patients and exercise caution when prescribing it to patients with a history of seizure disorder.

A range of resources on varenicline is available for consumers and healthcare professionals through the NPS website, including the consumer medicine information (CMI) sheet, peer reviews and journal articles.

'When starting any new medicine, people should read the consumer medicine information (CMI) sheet, which explains how the medicine works, what it’s for, how best to take it and any potential side effects,' Dr Weekes said.

Articles have been published in NPS’s Medicine Update, which is written for consumers and discusses medicines when they are added to the Pharmaceutical Benefits Scheme (PBS), and in NPS RADAR, which also discusses recently listed PBS medicines but is written for healthcare professionals.

For more information visit www.nps.org.au.

ENDS

The National Prescribing Service Limited (NPS) is an independent, non-profit organisation for Quality Use of Medicines funded by the Australian Government Department of Health and Ageing.