Chantix Gets A Black Box Warning

chantixToday the FDA announced that it would be requiring the makers of Chantix, a smoking cessation drug, to put a black box warning on its packaging.  The black box warning is the strongest step the FDA can take, short of pulling a drug from the market.

This New York Times article focuses primarily on the risk of depression and suicide.  The FDA has received 98 reports of suicide and 188 reports of suicide attempts among Chantix users.  However, I vividly recall reading this New York Magazine article first person account of Chantix's other psychological side effects, including terrifying nightmares and psychotic episodes.

Chantix first came to the attention of many people in conjunction with the sad story of Carter Albrecht.  A musician who played with Edie Brickell and the New Bohemians, Albrecht was by all accounts a kind and gentle man.  Right up until the night he violently attacked his wife, then ran next door and began trying to kick in his neighbor's door. 

Albrecht's neighbor, awoken from a sound sleep and sorely rattled by what was happening, fired a gun through his door to deter the man on the other side, not knowing that it was Albrecht.  He fired high, intending to give a warning shot.  Sadly, Albrecht was a tall man (6 foot 5) and the shot hit him in the face, killing him.

Albrecht had no history of domestic violence, or of violence of any sort.  However, he had recently begun taking Chantix, and he and his wife had been out drinking that night.  Chantix's warning label strongly advises against mixing Chantix with alcohol.

It's fairly easy to find other first person accounts of psychotic episodes while taking Chantix - simply search any stop smoking message board, or even Google, for phrases like "chantix + psychotic" or "chantix + rage."  Judging from what you can find on the internet, Chantix's psychological side effects are a lot more common than Phizer would have us believe. 

And yet, it's not as if the FDA is trolling message boards looking for evidence.  For one thing, in order to be clinically valid, these incidents have to be reported to the FDA.  Most people for whatever reason simply stop taking Chantix, and perhaps confess to some strange behavior on a message board one day.  The stigma of mental illness, the uncertainty of the cause and effect, and the difficulty in officially reporting "weird behavior" (as opposed to a clear cut statistic like suicide and suicide attempts), all may be acting to obscure the true risks from side effects of Chantix.

On the opposite side of the equation, the CDC reports that smoking results in 438,000 deaths per year in the United States, from causes such as emphysema, cancer, and heart disease.  Not to mention the cost, both financial and personal, of a daily smoking habit.  The truth is that every drug has side effects, Chantix included, but we take them anyway because the benefits outweigh the risks. 

If you're on Chantix, or thinking about taking Chantix, you have my wholehearted support.  But please be careful!