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Pfizer Adds Suicide Warning to Chantix

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Pfizer has decided to update its labeling on Chantix to inlcude warnings that the stop smoking drug could cause suicidal thoughts and other psychological problems in some users. The new Chantix warnings will caution doctors to monitor users for signs of depressed mood, agitation, suicidal thinking and suicidal behavior.  Despite the new Chantix warnings, Pfizer maintains that a “causal” link between the problems and Chantix has yet to be proven.

Pfizer’s decision to modify the Chantix label could be a move to head off regulatory action by the Food & Drug Administration (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.

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 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.

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.

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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