NEW YORK Pfizer’s smoking cessation drug Chantix has updated its label to include a warning that patients who are attempting to quit smoking with the drug should be observed for serious neuropsychiatric symptoms, including changed in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior, based on post-marketing reports.
The current update, based on Pfizer and FDA’s ongoing safety review of post-marketing reports, is provided to better ensure that healthcare providers and patients will appropriately consider this information in their discussions about Chantix. A causal relationship between Chantix and these reported symptoms has not been established. In some reports, however, an association could not be excluded.
In the clinical trial, more than 5,000 patients were treated with Chantix and changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior occurred at a rate comparable to placebo-treated patients.
According to Pfizer’s chief medical officer, Joe Feczko, “Chantix is a real breakthrough medicine that has helped many smokers who want to quit. We hope that today’s labeling change will further facilitate the important dialogue that should always occur between patients and their doctors when considering any prescription medication.”