Varenciline, which goes by the trade name of Chantix, is an anti-smoking drug renowned for getting smokers over any cigarette cravings. Whilst considered significantly effective, it is also known to cause significant moderate to severe psychological side effects.
The group given varenicline reported the usual side effects associated with the drug, including nausea, insomnia, abnormal dreams, anxiety, and irritability, at a higher frequency than the placebo group, but none of the adverse affects were considered serious.
This trial showed that the inclusion of varenicline in a smoking cessation program is efficacious in achieving long-term abstinence without serious adverse events, concluded the research team.
Varenicline did not increase the risk of heart attack
Another recent study reported that when compared to nicotine patches, varenicline did not increase one’s risk of heart attack or stroke. By analyzing hospital and death records from people who received the prescription quit smoking medicine between 2011 and 2015, the research team found no difference in incidence of major adverse cardiovascular events, such as heart attack or stroke, in people who were prescribed varenicline, as opposed to those who were prescribed nicotine patches.
The research team added that on the contrary, if anything there were less recorded instances of death from a cardiovascular event in people who were prescribed varenicline as opposed to patches.
Chantix’s known side effects
In the past following numerous reports of serious side effects, the FDA had placed the most severe warning available on the medication, which led to Chantix’s sales dropping from $846 million in 2008, to $671 million last year.
To compensate for this drop, Pfizer had invested heavily in advertising and settling lawsuits against the drug. Moreover, the Pharma company had released data retrieved from a study which allegedly proved that there is no direct link between the consumption of Chantix and experiencing psychological disturbances.
To this effect, after refusing to lift the warning in 2014, the FDA decided to change its stance and drop the warning. The agency required that the medication have its side effects listed, it also specified that the label should state that the medication is more effective than other smoking cessation therapies.
Meanwhile last June, Pfizer was forced to halt the distribution of varenicline and recall some stock after finding elevated levels of nitrosamines in the pills. However, the following month the FDA said it will temporarily allow some manufacturers to distribute the carcinogen-containing drug, below an interim limit of 185 ng per day, until the impurity can be eliminated or reduced to acceptable levels.
The FDA said the risk of exposure is relatively minimal
The US regulator said the health benefits of stopping smoking outweigh the cancer risk from the nitrosamine impurity in the medication. It explained that the risk of exposure to the carcinogen at interim acceptable intake levels up to 185 ng per day presents minimal additional cancer risk, in comparison to a lifetime exposure of 37 ng per day level.
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