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On Friday the FDA issue a Public Health Advisory for Pfizer’s popular smoking cessation drug Chantix. This advisory comes just two months after an Early Communication advised physicians of a possible link between Chantix and neuropsychiatric symptoms. The FDA has now said that it is becoming increasingly likely that this association exists. The shooting death of Dallas musician Carter Albrecht, reportedly to be linked to Chantix, triggered public awareness and controversy about the drug. Since then numerous claims of aggression, depression, suicidal ideation and even suicidal action have been reported. In the UK public controversy was sparked when at least three suicides were linked to the drug. While more research is needed to draw conclusive results, it does appear that Chantix may affect some people far more than making them not want to smoke.

“Chantix has proven to be effective in smokers motivated to quit, but patients and health care professionals need the latest safety information to make an informed decision regarding whether or not to use this product,” said Bob Rappaport, M.D., director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products. “While Chantix has demonstrated clear evidence of efficacy, it is important to consider these safety concerns and alert the public about these risks. Patients should talk with their doctors about this new information and whether Chantix is the right drug for them, and health care professionals should closely monitor patients for behavior and mood changes if they are taking this drug.”

No causal relationship has been established between Chantix and neuropsychiatric events; however, an association cannot be ruled out. Patients with preexisting mental heath problems should exercise extra caution as study results suggest that Chantix may trigger old mental illness to present themselves again. The FDA will continue to monitor reports associated with Chantix, and along with ongoing studies and data analysis hopefully we will soon know exactly why some people have responded to the medication in the way they have.

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