There is no evidence of serious side effects from a popular drug used to help smokers quit tobacco, according to a new analysis.
Varenicline has been linked to cardiovascular disease and to depression.
But a study by the University of Edinburgh says users of the drug are no more at risk than other smokers seeking to give up.
The findings come from an analysis of English primary care records in the Qresearch database.
This allowed the researchers to study more than 150,000 smokers taking varenicline, bupropion or nicotine replacement therapy.
The researchers tracked users for six months after they began taking treatment for the study, reported in The Lancet Respiratory Medicine.
Researcher Professor Aziz Sheikh said: "On the basis of our extensive analysis, we believe it is highly unlikely that varenicline has any significant adverse effects on cardiac or mental health.
"Regulators such as the United States Food and Drug Administration should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid."
Fellow researcher Professor Daniel Kotz, from the Heinrich-Heine-University Dusseldorf, said: "Smokers typically lose three months of life expectancy for every year of continued smoking. Our research supports the use of varenicline as an effective and safe tool to help people quit."
Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study Lancet Respiratory Medicine. [abstract]
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