Health benefits of quitting smoking may outweigh small CVD risks of varenicline

NPS MedicineWise is reiterating advice that health professionals need to weigh the potential small cardiovascular risks associated with the quit-smoking medicine varenicline (Champix) against the immediate and substantial benefits of quitting smoking.

Following the release of a new meta-analysis from varenicline’s manufacturer, NPS MedicineWise clinical adviser Dr Philippa Binns says the medicine’s risks should be considered in balance with the patient’s long-term health objectives.

“For people with no history of cardiovascular disease who are starting varenicline for smoking cessation, health professionals should advise that the medicine may cause a small increase in their absolute risk of a cardiovascular event,” says Dr Binns.

“But this small risk needs to be weighed up against the cardiovascular benefits if the patient is successful in quitting smoking as a result of taking the medicine.”

For people with cardiovascular disease who wish to quit smoking, there are other smoking-cessation options to be considered including counselling support alone and nicotine replacement therapy.

“Health professionals should advise patients to seek medical attention if they experience new or worsening symptoms of cardiovascular disease while taking varenicline,” says Dr Binns.

Following a US Food and Drug Administration (FDA) warning in 2011 of a possible increase in risk of serious cardiovascular events in people using varenicline, the sponsor was required to conduct a meta-analysis of randomised placebo-controlled trials.

The completed meta-analysis reported on the FDA website indicates a small, statistically non-significant increase in cardiovascular events in people taking varenicline. Nevertheless, the FDA concluded that since this increase was consistent throughout different analyses it is likely to be drug-related and not purely a chance finding.

An article about the meta-analysis will appear in this month’s NPS Direct e-newsletter, written by NPS MedicineWise and distributed free to health professionals.

To read the full article and to subscribe to NPS Direct visit

NPS MedicineWise also has resources for health professionals about medicines to treat nicotine addiction at

For more information on prescription, over-the-counter and complementary medicines (herbal, ‘natural’, vitamins and minerals) from a health professional, patients can call NPS Medicines Line on 1300 MEDICINE (1300 633 424) . Hours of operation are Monday–Friday 9am–5pm AEST (excluding public holidays).


Independent, evidence-based and not-for-profit, NPS MedicineWise enables better decisions about medicines and medical tests. We are funded by the Australian Government Department of Health and Ageing.