Kristie McNealy, MD

Each year, smoking kills hundreds of thousands of people in the US, and smokers are constantly urged to quit by using any number of stop smoking drugs, programs or systems. There is bad news for some would be quitters though. The US Food and Drug Administration is once again expressing concern over Pfizer’s anti-smoking drug Chantix (varenicline). To date, there have been nearly 500 reported cases of suicidal thoughts and 39 completed suicides among patients taking Chantix. The drug, which binds nicotine receptors in the brain is believed to cause the worsening of psychiatric symptoms, even if they are well controlled before starting the medication.

Chantix was originally approved by the FDA in May 2006, and an FDA communication in November of 2007 expressed concerns over reports of increased suicidal thoughts in patients taking the drug. According to Pfizer, Chantix will now contain a stronger warning for patients and physicians stating that:

Patients who are attempting to quit smoking with CHANTIX should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

Pfizer stresses that there was no evidence of worsening psychiatric symptoms in the original 5,000 person, placebo controlled trial, but that trial did not include people a history of serious psychiatric disorders. While smoking is a dangerous habit, it’s obviously important to weigh the potential risks and benefits of any stop smoking program or medication before beginning it. If you want to quit smoking, you can find free information on how to quit at SmokeFree.gov.

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