While anti-smoking drugs are generally celebrated for their ability to help smokers quit their habit and improve their health, there have been concerns about their safety with the potential to trigger psychiatric side effects. Now a new study helps to put some of those concerns at rest as researchers determine smoking cessation drugs do not increase the risk of mental health problems.
The study, the largest of its kind, comes from Robert Anthenelli, MD, and other researchers at the University of California San Diego. They published their results in the journal Lancet April 22nd. Called the EAGLES trial, the research involved 8,144 smokers aged 18 to 75, from 16 different countries, and was funded by drug manufacturers Pfizer and GlaxoSmithKline. The researchers aimed to determine the safety and effectiveness of the smoking cessation drugs varenicline, better known by the brand names Chantix and Champix, and bupropion, better known by the brand names Wellbutrin and Zyban.
The researchers evaluated the study participants at the beginning of the study to determine the presence of an existing psychiatric disorder, with 4,116 placed in the psychiatric group and 4,028 in the non-psychiatric group. They were then split into four groups: one group received varenicline, one group received bupropion, one group received a nicotine replacement therapy patch as a comparison, and one group received a placebo. The study participants were treated with their drug for 12 weeks, along with brief smoking cessation counseling at each visit, and a 12-week follow-up without treatment.
The study found that those in the psychiatric group were more likely to experience moderate to severe mental health side effects during the study than those in the non-psychiatric group. However, they were no more likely to have these side effects while taking varenicline or bupropion than while taking the nicotine patch or a placebo. This suggests that taking these smoking cessation drugs does not increase the risk of psychiatric side effects, even in the presence of existing mental health disorders. This may come as good news to those hoping to quit smoking but worried about the side effects.
In addition to examining side effects, the researchers looked at the ability of the different drugs to help people quit smoking. They found that those using the nicotine patch and bupropion were twice as likely than those taking a placebo to have remained smoke-free at follow-up. However, those taking varenicline were the most likely to have stopped smoking by that time.
As encouraging as the results of the study are, some point out the limitations. The study excluded participants with other substance abuse issues so the safety of smoking cessation products in this group is still unclear.
The United States Food and Drug Administration (FDA) requested the study, prompted by Pfizer’s desire to remove a black box label from the drug in the U.S. Chantix was approved in 2006 but the FDA ordered the label in 2009, warning of a potential increase in the risk for depression and suicidal thoughts. Citing new data in 2014 that suggested little psychiatric risk, Pfizer had requested that the label be removed, opening up the drug for use by smokers with psychiatric disorders.
Smoking is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths each year in the U.S. alone. Research has linked smoking to lung cancer and other cancers, chronic obstructive pulmonary disease (COPD) and other lung disorders, heart disease and stroke, pregnancy problems, reduced bone health and rheumatoid arthritis, cataracts and other eye issues, type 2 diabetes, and a wide range of other health problems. Quitting can drastically reduce the risk of these health problems, so health officials promote the benefits of smoking cessation. With more variety in smoking cessation aids increasing the chance a smoker will find the one that works for them, the results of the study are encouraging, giving those with psychiatric disorders one more tool they can use to help them quit smoking.