Dr. David Gunnell of the University of Bristol, UK, and co-author of the study stated, “There have been recent concerns that varenicline, a relatively new smoking cessation product, may increase the risk of suicidal behavior and suicide.
“We found no clear evidence of an increased risk of self-harm or depression
associated with varenicline.”
In order to quell the risk concerns, researchers from the university and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) conducted a study to provide further evidence.
They weighed the risk of self harm among people taking varenicline with other stop-smoking products like bupropion and nicotine replacement therapy (patch, inhaler, gum, tablet or lozenge).
A cohort study conducted
The researchers used data from the General Practice Research Database. The study included 80,660 men and women aged between 18 and 95 years who used different smoking cessation product between September 2006 and May 2008.
The subjects were prescribed nicotine replacement products (63,265), varenicline (10,973), and bupropion (6,422).
They then examined the electronic patient records during the period of the prescription, and for three months after the date of the last prescription, for events of self-harm, suicidal thoughts and depression.
The researchers found 166 incidences of self-harm and two suicides (both in patients prescribed nicotine replacement therapy).
Gunnell stated, "This is the first study to look at this question in detail, and the results are largely reassuring. Our best estimate is that if there is an increase in the risk for fatal and non-fatal self-harm associated with [Chantix] the risk is likely to be very small."
Need for further investigation
The researchers point out that nicotine withdrawal is very difficult for people to endure and often aggravates existing mental problems.
Though the researchers found no concrete proof to establish a relationship between the drug and suicidal events, they feel there is need for further investigation to identify the impact of varenicline on those risks.
They caution that “the limited power of the study means we cannot rule out either a halving or a twofold increased risk."
The researchers conclude that the benefits of the drug outweigh any possible risks. However, the ideal approach would be if smokers avoid drug treatment when trying to quit and take a natural approach that has no adverse side-effects.
The findings have been published in the British Medical Journal (BMJ) online.
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