Chantix Gets New Warning of Suicide, other Psychological Problems

<"">Chantix, the stop smoking drug that has reportedly caused suicidal thoughts and other psychological problems in some users, will soon bear new warnings.  Pfizer, the maker of Chantix, has chosen to include warnings about instances of depressed mood, agitation, suicidal thinking and suicidal behavior that have been reported among some users of the pill, even though the company claims that a “causal” link between the problems and Chantix has yet to be proven.

Such Chantix side effects may have played a part 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.    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.    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.  It was the Albrecht death that first put a spotlight on possible Chantix problems.

Chantix, approved in 2006, works by blocking nicotine receptors to the brain.  Chantix is the first such nicotine receptor partial agonist approved by the Food & Drug Administration (FDA).  It was heralded as an alternative to other smoking cessation drugs and nicotine replacement therapy. Prior to Pfizer’s announcement that it would be adding new warnings, the Chantix  package insert warned  that psychotic and suidical behavior were potential side effects.  But that caution 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.

Today Chantix is getting a warning on its U.S. label that asks doctors to monitor for suicidal behavior, depressed mood and other psychological problems. While Pfizer has conceded that it has received various reports of psychological problems in people taking Chantix, the company won’t say how many.  And Pfizer insists that people giving up smoking, or people who are smokers in the first place, tend more toward depression than their nonsmoking peers.

Pfizer’s decision to modify the Chantix label could be a move to head off regulatory action by the FDA.  In November, the FDA announced that it was beginning a safety review of Chantix after Pfizer submitted several postmarketing cases to the agency describing suicidal thoughts and occasional suicidal behavior possibly linked to Chantix use.  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.

According to The Wall Street Journal, Chantix is  used by more than five million patients and had sales of $603 million through the third quarter of 2007, in its first full year on the market.

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