Smoking cessation drug not linked to an increased risk of self harm or depression

Oct 01, 2009

There is no strong evidence that the popular smoking cessation drug varenicline increases the risk of self harm or depression compared to other cessation products, according to new research published on BMJ.com today.

Varenicline is a recently introduced smoking cessation product of proven effectiveness, but there have been concerns that it may increase the risk of and suicide. Despite warnings about the possible increased risks issued by regulatory authorities worldwide, varenicline continues to be used widely.

To provide more evidence, a team of researchers from the University of Bristol and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) compared the risk of self harm among people taking varenicline with the risk of self harm associated with other smoking cessation products bupropion and nicotine replacement therapy (patch, inhaler, gum, tablet or lozenge).

Using data from the General Practice Research Database, 80,660 men and women aged between 18 and 95 years were identified who were prescribed a new course of smoking cessation product between September 2006 and May 2008.

Participants were prescribed either nicotine replacement products for (n=63, 265), varenicline (n=10,973), or bupropion (n=6,422).

All electronic patient records over the period of the prescription and for three months after the date of the last prescription were examined for incidences of fatal and non-fatal self-harm, suicidal thoughts and depression.

After controlling for confounding factors, there was no clear evidence of an increased risk of self harm, or depression associated with either varenicline or bupropion.

The authors caution that although they found no strong evidence of an increased risk of self harm linked to varenicline, "the limited power of the study means we cannot rule out either a halving or a twofold increased risk."

They go on to call for more investigation of varenicline's effect on in other databases and secondary analysis of all adverse event reporting in clinical trials.

They conclude by cautioning that any risks must be balanced against the long term health benefits of stopping smoking and the effectiveness of varenicline as a product.

Source: British Medical Journal (news : web)

Explore further: Mirabegron for overactive bladder: Added benefit not proven

add to favorites email to friend print save as pdf

Related Stories

Smoking cessation therapies more effective than placebos

Jul 14, 2008

Six treatments for smoking cessation perform better than placebos — including varenicline (Chantix®), recently approved for use in Canada — states a team of researchers from McGill University and the University of Montreal ...

FDA: New warning needed for Chantix

Feb 03, 2008

The U.S. Food and Drug Administration Friday called for increased awareness of the health risks of the smoking cessation drug varenicline.

DNA (driver of nicotine addiction)

Jan 29, 2008

Cigarette smoking is the largest preventable source of death and disability in the USA, contributing to ~ 400,000 deaths annually. Despite widespread knowledge of the health dangers, ~ 1 in 8 American adults is a habitual ...

Recommended for you

Mirabegron for overactive bladder: Added benefit not proven

4 hours ago

Mirabegron (trade name: Betmiga) has been approved since December 2012 for the treatment of adults with overactive bladder. In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products ...

Novartis Japan admits concealing drug side effects

Sep 01, 2014

The Japanese unit of Swiss pharma giant Novartis has admitted it did not report more than 2,500 cases of serious side effects in patients using its leukaemia and other cancer drugs, reportedly including some fatalities.

Most US babies get their vaccines, CDC says

Aug 28, 2014

(HealthDay)—The vast majority of American babies are getting the vaccines they need to protect them from serious illnesses, federal health officials said Thursday.

User comments : 0