![]() ![]() These warnings were based on postmarketing reports describing changes in mood and behavior during and after Chantix use (see 2008 Public Health Advisory and 2009 Public Health Advisory).įDA is continuing to evaluate the risk of neuropsychiatric events with Chantix. Such events can include changes in behavior, hostility, agitation, depressed mood, and suicidal thoughts or actions. 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. ![]() 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. 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. 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. 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 (see Data Summary below for more information). Neither study found a difference in risk of neuropsychiatric hospitalizations between Chantix and nicotine replacement therapy (NRT e.g., NicoDerm patches).
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