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FDA Date: 10/24/11
Chantix FDA Drug Safety Communication
FDA Drug Safety Communication for Chantix Safety Review Update of Chantix (varenicline) and Risk of Neuropsychiatric Adverse Events
FDA has reviewed the results from two FDA -ponsored epidemiological studies that evaluated the risk of neuropsychiatric adverse events associated with the smoking cessation drug Chantix (varenicline). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT; eg, NicoDerm patches).
However, both studies had a number of study design limitations, including only assessing neuropsychiatric events that resulted in hospitalization, and not having a large enough sample size to detect rare adverse events. 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.
Healthcare professionals and patients should continue to follow the recommendations in the physician label and the patient Medication Guide, and to monitor for neuropsychiatric symptoms when prescribing or using Chantix. Based on FDA's assessment of currently available data, the Agency continues to believe that the drug's benefits outweigh the risks and the current warnings in the Chantix drug label are appropriate.
The risk of serious neuropsychiatric events with Chantix is currently highlighted in the Boxed Warning and Warnings and Precautions section of the physician label and in the patient Medication Guide. Such events can include changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. These warnings were based on postmarketing reports describing changes in mood and behavior during and after Chantix use.
Overall, FDA has determined that the current warnings in the Chantix drug label, based on postmarketing surveillance reports, remain appropriate.
FDA is continuing to evaluate the risk of neuropsychiatric events with Chantix. The drug manufacturer is conducting a large safety clinical trial of Chantix to assess neuropsychiatric adverse events; results from this study are expected in 2017.