Varenicline: Big foot, crop circles and the big black box

I helped a middle aged male patient quit smoking. I offered “smoking cessation medication” to him and he accepted it.  He had no psychiatric history. Within a week, his wife called me to report odd behavior.  He was staying up late, delusional, sexually aggressive, expressed thoughts of suicide. I had to hospitalize him in a psychiatric hospital.  When we stopped “the medication”, he became “normal” and has had no problems since.  Was it due to Varenicline? NO!!!  It was in the mid 1990’s, a full decade before Chantix was marketed in the US.  The drug?  Nicotine replacement patches. 

Mysterious reports of suicide and suicidal ideation NOT SEEN in randomized controlled trials have popped up all over the world.  Much like reports of crop circles and Big Foot, it’s really hard to track them down.  It’s difficult to find a normal person with no history of depression, no life stressors, and no alcohol use who just jumped up and committed suicide on Verenacline. On the other hand and so tragically, it’s very common for patients to commit suicide for a variety of reasons. It’s an entity as old as Judas Iscariot and it isn’t likely something that will go away anytime soon.       

US suicide rates increased for the first time in a decade according to a report in October 2008 from the Johns Hopkins Bloomberg School of Public Health’s Center for Injury Research and Policy.  The increase was noted from 1999-2005 BEFORE VARENICLINE CAME ONTO THE AMERICAN MARKET and primarily due to an increase in suicide among middle aged whites from ages 40-64.  An unusual finding was that rates in women demonstrated the most significant jump, a first -time statistic.  The full report was published in the American Journal of Preventive Medicine in December 2008.

Suicide is the 7^th leading cause of death in the US.  In 1996, 31,000 US citizens committed suicide. According to reports, it’s bad to be from Alaska, Nevada, New Mexico, or Montana all with the highest rates of suicide in the US. (Do they sell more Varenicline in those states?  Wait, that was 1996, no varenicline to blame there),  but it’s good to be from Washington D.C. and the state of  New York with the lowest rates.  It’s bad to be in a bad relationship, to drink alcohol or to be a New York City police officer, all of which are associated with a higher risk of taking ones life. (Maybe we should put a black box warning on bad relationships, alcohol or law enforcement as a profession).  One article sited Veterinarians as having an unusually high rate of suicide. Go figure.  I thought folks who were pet people were relatively well adjusted and happy.  With suicide rate reporting, there must be more to it than meets the eye. Hmmm…………..

The most recently published information on Varenicline was presented in Orlando 3/09 at the ACC demonstrating that of 714 adults randomized to varenicline or placebo NONE OF THEM demonstrated suicidal ideation or suicidal behavior. My personal experience with smoking cessation period is that quitting smoking is tough .  We gleaned this information from the standing whine from unsuccessful quitters that usually goes something like this:  “I had to either start back or kill my husband”. Do you get the idea that quitters get a bit aggressive, even when they go cold turkey?

 There is simply too much good randomized controlled data available to combat this unfounded rumor of suicidal behavior with Varenicline.  Unfortunately, with billions of dollars of blood money to spend, the tobacco industry can fan the flames until we all believe we’ve seen a Big Foot in our back yard.  As prescribing physicians we must continue to rely upon fact and not innuendo. Varenicline is an excellent tool for smoking cessation and with the exception of nausea, headache and stomach upset, it’s relatively benign. We should discuss with our patients the reports of aggressive behavior and suicidality with the FACTS firmly in hand .

   When faced with the option of lung cancer, sudden death, heart attack, stroke or choking to death slowly over a decade, or sinking myself into poverty and illness, or  abandoning my family too early in the name of tobacco addiction,  I’ll take my chances with Big Foot, a crop circle or whatever is in the black box any day.    

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