Chantix Adds Warning to U.S. Label
Pfizer, the maker of Chantix, a drug approved by the FDA to assist smokers in quitting, has updated the product's label to include a warning that patients who are using Chantix should be watched for serious neuropsychiatric symptoms, such as changes in behavior, agitation, depressed mood, and suicidal thoughts or behavior. A causal relationship has not been established between the use of Chantix and these symptoms, but, in some reports, could not be ruled out. These are results of Pfizer and the FDA's ongoing safety review of post-marketing reports. |