Today’s FDA warning follows a Nov. 20, 2007, FDA Early Communication to the public and health care providers that the agency was evaluating postmarketing adverse event reports on Chantix related to changes in behavior, agitation, depressed mood, suicidal ideation, and actual suicidal behavior.
Chantix, approved in 2006, works by blocking nicotine receptors to the brain. Chantix is the first such nicotine receptor partial agonist approved by the FDA. It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy.
According to the FDA Nov. 20 Early Communication, Pfizer had submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use. At the time, the FDA said that its preliminary assessment revealed that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment.
The role of Chantix in these cases is not clear, the FDA said
The role of Chantix in these cases is not clear, the FDA said, because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
Today, the FDA said “it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms.” The agency said that it had asked Pfizer to elevate the prominence of this safety information regarding suicidal thoughts and other psychiatric problems to the warnings and precautions section of the Chantix prescribing information, or labeling. In addition, the FDA is working with Pfizer to finalize a Medication Guide for patients.
Earlier this month, Pfizer had announced that it would be making warnings on suicide and other psychiatric problems on the Chantix label more prominent. The previous caution regarding these problems was far less prominent than the warnings for other various side effects, including nausea, changes in dreaming, constipation, and gas and vomiting that appeared on the Chantix label.
Chantix may have played a role in the death of musician Carter Albrecht. Albrecht, best known as a member of Edie Brickell and the New Bohemians, started taking Chantix in late August 2007. He was well liked in the community, and had no prior history of violence.
Immediately, Albrecht began to complain of vivid, hallucinatory dreams — a common Chantix side effect. One night about a week after he started taking Chantix, Albrecht had a violent encounter with his girlfriend. The episode occurred after Albrecht had consumed a couple of alcoholic drinks.
Albrecht’s girlfriend reported that he was confused, and did not recognize her. Before the night was over, Albrecht had been shot dead by a terrified neighbor on whose property he had trespassed.