A study has cleared varenicline – also known as Champix™ or ChantixTM – of not being responsible for increased risk of heart attacks and depression thereby recommending a review of the safety warning related to the drug in the US.
Varenicline is considered the most effective medication that helps smokers quit; however, access to the drug is limited in many countries including the US as it has been associated with increased risk of heart attacks, depression, self-harm and even suicide.
The study, led by researchers at Universities of Edinburgh and Dusseldorf, is the first of its kind that simultaneously studied the potential side effects and echoed findings of few other recent studies that the drug has no a negative effect on mental health of the person taking it. Further, the study also negated the claims that the drug is responsible for increased risk of heart disease.
For the study, researchers analysed anonymised health information from more than 150,000 smokers across England. The patients were either prescribed varenicline or another anti-smoking drug called bupropion to help them quit, or had used nicotine replacement therapy – such as patches, chewing gum or lozenges. Researchers tracked the patients for six months to assess any impact of the treatment on their health.
The findings suggest that neither varenicline nor buproprion increased the chances of heart attack and that the probably of a person taking the drug and suffering from heart disease was the same as that of a person on nicotine replacement therapy. People were also not at higher risk of depression or self-harm, researchers say.
Professor Daniel Kotz, from the Medical Faculty of 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.”
Professor Aziz Sheikh, Co-Director of the University of Edinburgh’s Centre for Medical Informatics, 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 (FDA) should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid.”
The findings of the study have been published in the Lancet Respiratory Medicine.