Washington D.C: Turns out, the smoking cessation medications varenicline and bupropion, which were earlier thought to increase the risk of serious neuropsychiatric side effects, are actually safe, as per a new study. The University of California study looked at the safety and efficacy of three first line smoking cessation treatments – varenicline, bupropion and nicotine patches – compared to placebo in smokers with and without psychiatric disorders and found than smokers, who took varenicline achieved higher abstinence rates than smokers on bupropion, nicotine patches, or placebo.
The study involved more than 8000 people and was requested by the US Food and Drug Administration (FDA) following concerns about the neuropsychiatric safety of varenicline and bupropion.
Lead author Robert M. Anthenelli said that the clinical guidelines recommend that the most effective way to give up smoking is smoking cessation medication and counselling. However, smokers do not use these services enough, in part due to concerns that the medications may not be safe.
Anthenelli added that the findings, together with data from previous trials and large observational studies, make it highly unlikely that varenicline and bupropion increase the risk of moderate-to-severe neuropsychiatric side effects in smokers without psychiatric disorders. Anthenelli explained that the study provides further evidence of the safety of these drugs in smokers with psychiatric disorders, who have some of the highest rates of smoking.
The authors warn that since the participants had a stable psychiatric disorder and were being treated, the findings might not apply to those with untreated or unstable psychiatric illness. The researchers also excluded people with current alcohol or substance abuse disorders and people who were at imminent risk of suicide.
The study also did not look at whether the strength of nicotine dependence or the severity of psychiatric symptoms affected the findings. Finally, just over 20 percent of people dropped out of the study but this was seen across the board, whether or not participants had a psychiatric disorder and irrespective of whether they received one of the three treatments or placebo. The study is published in The Lancet.