While previous research has linked the smoking cessation drug varenicline to increased risk of depression and heart disease, a new study has found no such association.
Varenicline (brand name Chantix) is a drug that was approved by the US Food and Drug Administration (FDA) in 2006 to help people quit smoking.
The drug works by stopping nicotine from binding to nicotine receptors in the brain, reducing the release of dopamine – a neurotransmitter that regulates the brain’s reward and pleasure centers. The reduction in dopamine levels is believed to reduce nicotine cravings.
Previously, studies have associated varenicline with poorer heart health and increased risk of mental health problems. In 2007, for example, Medical News Today reported on a safety warning issued by the FDA claiming the drug may lead to suicidal thoughts, while a more recent study associated varenicline with greater risk of severe cardiovascular events, such as heart attack and congestive heart failure.
For this latest study, published in The Lancet Respiratory Medicine, researchers from the UK, US and Germany set out to further assess the potential side effects of varenicline using the data of more than 150,000 adult smokers across England who had attempted to quit the habit.
Some of the study participants had used nicotine replacement therapy – such as nicotine gum or patches – as a smoking cessation aid, while others had been prescribed varenicline or another antismoking medication called bupropion.
Compared with participants who received nicotine replacement therapy, the researchers found those who were prescribed varenicline or bupropion were at no greater risk of heart disease, depression or self-harm.
Tobacco use remains a major health concern in the US, with around 1 in 5 American adults currently smoking cigarettes. Tobacco use is the largest preventable cause of death in the US, with smoking killing more than 480,000 Americans every year.
According to the study authors, the results of their study support increased use of varenicline as an “effective and safe” smoking cessation aid.
Study co-author Prof. Aziz Sheikh, of the Centre for Medical Informatics at the University of Edinburgh in the UK, adds:
“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 FDA should review its safety warning in relation to varenicline as this may be unnecessarily limiting access to this effective smoking cessation aid.”
While the results of this study may bring hope to many patients using varenicline to quit smoking, the FDA issued an updated safety announcement for the drug earlier this year, in which they warned varenicline may cause seizures and alter the way the body reacts to alcohol.