(RxWiki News) For many longtime smokers, quitting cold turkey is far from easy. But there may now be some good news for smokers looking to kick the habit.
“In summary, our results provide no evidence for a causal association between varenicline and the incidence of criminal offending, suicidal behavior, transport accidents, traffic offences, and psychoses,” wrote the study authors, led by Seena Fazel, MD, of the University of Oxford in England.
Varenicline is a drug designed to help tobacco users kick the habit. After some reports linking varenicline to depression and suicidal behavior recently emerged, the US Food and Drug Administration (FDA) issued a warning about the drug’s potential side effects.
This study found no link between use of the drug and those behaviors, however.
Dr. Fazel and team looked at data from the entire population of Sweden from November 2006 to December 2009. They compared rates of suicidal behavior, crimes and new psychiatric conditions in the general population with those rates in patients taking varenicline.
Out of Sweden's population of about 8 million, about 70,000 were taking varenicline, Dr. Fazel and colleagues found.
In the population taking varenicline, 5.4 percent were suspected of a crime, 4.6 percent were diagnosed with a new psychiatric condition, 1.4 percent were involved in a traffic-related incident and 0.9 percent received medical care for suicidal behaviors, Dr. Fazel and team found.
In the same time period — in the untreated population — 4.0 percent were suspected of a crime, 2.2 percent were diagnosed with a new psychiatric condition, 1.4 percent were involved in a traffic-related incident and 0.3 percent received medical care for suicidal behaviors.
These results indicated that varenicline may not be linked to suicide, criminal offending, car accidents or psychosis. However, Dr. Fazel and team found that it was linked to an increased risk of anxiety and mood disorders. They only saw this risk in patients who already had psychiatric conditions.
While these results may spell good news for varenicline, the drug still carries the FDA's strongest warning — known as a black box warning. The drug's labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes.
The FDA also released a safety announcement in March 2015 that varenicline may reduce the user’s tolerance for alcohol, which may lead to aggressive behavior or amnesia. The FDA said doctors should weigh the drug's risks against its potential benefits of helping patients quit smoking.
This study was published June 2 in the journal The BMJ.
Dr. Fazel disclosed that his travel expenses were paid by Janssen.
The Wellcome Trust, the Karolinska Institutet, the Swedish Research Council for Health, Working Life and Welfare and the Swedish Research Council funded this research.