FDA: Nicotine Therapy Patches Pose Same Risk As Chantix

In the midst of intense criticism and scrutiny, two U.S. studies refute accusations that suggest Chantix is responsible for the development of more adverse neuropsychiatric events than other nicotine replacement therapies. According to studies funded by the U.S. Food and Drug Administration (FDA), both nicotine therapy patches and Chantix may increase the risk of neuropsychiatric events.

Chantix was originally introduced to interstate commerce by Pfizer in 2006. Soon after gaining the FDA’s approval, Chantix became one of the most popular smoking cessation medications on the market. However recent studies have suggested that Chantix side effects may include neuropsychiatric injuries leading to behavioral changes, depression, aggression, agitation, hostility, rage, suicidal ideation, suicide attempts and, in many cases, successful suicide.

Contradictory to the wide-spread belief, two U.S. studies suggest that Chantix does not lead to more hospitalizations than nicotine replacement therapies such Sanofi’s NicoDerm patches. The FDA sponsored two observational studies with Chantix conducted by the Department of Veterans Affairs and the Department of Defense. Each of which identified no statistical difference in adverse neuropsychiatric events that led to hospitalization.

In association with the FDA, the Veteran Affairs study compared 14,131 patients receiving Chantix treatment with an equal amount of patients using other variations of nicotine replacement therapy. Their result identified five more adverse neuropsychiatric events associated with treatments other than Chantix. Subsequently, only 16 patients using Chantix were hospitalized for psychiatric reasons, while 21 were hospitalized by other methods.

The second study, conducted by the Pentagon, studied 11,978 Chantix users and an equal number of replacement therapy patients. According to this study, 18 patients receiving Chantix treatment were hospitalized for adverse neuropsychiatric events. However, other nicotine replacement therapies were only responsible for 16 hospitalizations.

While these studies do not indicate a difference in nicotine replacement therapies, the FDA would like to reiterate that both studies had a number of study design limitations. According to the FDA, the studies only reviewed neuropsychiatric events that resulted in hospitalization, and they did not have a large enough sample size to detect rare adverse events. Thus, the FDA has reason to believe that neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy.

Although these two studies did not suggest an increased risk of neuropsychiatric events that result in hospitalization, they do not rule out an increased risk of other neuropsychiatric events with Chantix. The FDA is continuing its efforts to evaluate the risk of neuropsychiatric events associated with Chantix. Accordingly, the agency has requested that the drug manufacturer conduct a large safety clinical trial of Chantix to assess neuropsychiatric adverse events. Results from this study are expected in 2017.

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Again, if you or a loved one has been injured by Chantix, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.