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Chantix's suicide risks are higher compared to other smoking-cessation treatments, according to a new study appearing in the journal PLoS One.
The drug aims to help individuals quit smoking. But the side effects of the drug may make it more dangerous than previously realized.
Chantix, or varenicline, is reportedly 8 times more likely to be linked with suicidal behavior and other psychiatric side effects like depression compared with other nicotine replacement products.
This isn't the first time that the drug has faced scrutiny. In 2009, the FDA placed a "black box" warning on the drug that warned consumers that it could cause "serious mental health events including changes in behavior, depressed mood, hostility, and suicidal thoughts," reports Time.
A "black box" warning is one of the strongest the FDA issues.
Typically, drug manufacturers have the duty to warn about side effects if they are known to occur. They don't have the duty to warn about unknown dangers of drugs. Drug companies are usually required to continually keep on top of medical research and update professionals on new dangers associated with the drug when they are discovered.
Maybe the manufacturer or the FDA should update the drug's warnings. However, Pfizer, the manufacturer, has taken issue with the study's conclusions. They say the findings are unreliable.
They are currently conducting trials to research potential psychological side effects of Chantix, at the request of the FDA. ABC News reports the results won't be out until 2017.
But before this study is completed, there are still many years where consumers could be taking the drug without knowing Chantix's suicide risks. With this study on the table, it is possible Pfizer could face liability if they don't inform medical professionals about these potential new risks if the study is found to be reliable.