Bad reputation: Chantix may have to keep its “black box” warning

Pfizer's controversial smoking cessation drug may not have persuaded the FDA yet


Pfizer wants the FDA to remove the “black box” warning from its smoking cessation drug Chantix, but the FDA is pushing back. Last year, the FDA kept the label in place, pending the results of a major study Pfizer was then in the process of conducting, according to Reuters.

The study of more than 8,000 users is now complete, and it supposedly shows that Chantix did not cause an increase in serious neuropsychiatric side-effects.

However, FDA staff disagree. They claimed that there were inconsistencies in data collection, and that the severity of some side effects was mischaracterized. The FDA opinions were part of a preliminary review before a meeting of an advisory panel Wednesday to review the findings of Pfizer’s study.

The black box contains a message that warns Chantix users about suicidal thoughts, hostility, and agitation.

Despite clinical trial results showing it to be safe and well-tolerated by most patients, serious side effects — including suicide and murderous rages — have been reported almost since the day it was first sold. So many users have reported side effects, in fact, that the FDA forced Pfizer to put a “black box warning” on the package, the most severe warning label possible. The black box contains a message that warns Chantix users about suicidal thoughts, hostility, and agitation.

Chantix brought in $671 million for Pfizer last year. In four years, they will lose patent exclusivity, and will be forced to compete with generic versions. Removing the black box warning could help the company maximize profits from the problematic drug before that happens.

Marc Bruxelle /

Jim McDonald
I spend most of my time studying the regulatory, legislative and scientific challenges to vaping, advocating for our right to exist, and talking with others who do the same. Consider me a source for information, and feel free to agree or disagree with anything I say. I love good coffee and sweet Michigan cherries. My childhood hero was Gordie Howe.
  • Jim, I loved that you used a photo of Viagra for your lead image…at least, that’s what a friend told me it looks like. Wait. Never mind.

  • tmom

    I tried Chantix a few years ago. I felt like I was doing meth, and smoked 2 times a much as before. I can see the rages and suicide.

  • Sharon Thompson

    I think Chantix should be banned totally. It was prescribed for me by my doctor before the neurosurgeon would perform surgery on my neck. Even though I had suffered from pain and diminished physical mobility, I had always had a positive engaging and happy attitude. I now have NO life, I am unfortunately alive. If I was an animal, someone would put me out of my misery. I can not put into words how badly depression ends life. As soon as the neurosurgeon said I had healed I returned to smoking. It’s been 8 years since I used Chantix. I am on antidepressants, that only keep me from crying nonstop. Last year the ambulance came for me, I could not figure out what was going on. They found a huge mass growing on my brain. They cutoff almost half of my skull to remove it. Unfortunately they did not remove the depression and I am still alive. Is the risks of Chantix worth the reward of not smoking? NO! 2+ years ago my daughter bought me a vape pen, I’m a non-smoker now.

    • Jim McDonald

      I hope you get some treatment for your depression. It sounds terrifying. I’m glad you were able to quit smoking.

  • Tara Caron Antonuccio

    So Pharma gets it’s way, and the FDA votes to remove the black box warning from Chantix. I heard it only passed by one vote, and that the deciding vote was made by a gentleman with -surprise!- Pharma ties. The conflicts of interest within the FDA to various pharmaceutical companies is outrageous. I get so angry about the vaping issue, on a daily basis. I want these criminals prosecuted…and I hate the feeling of powerlessness it gives me.

    • Jim McDonald

      I don’t think the FDA has made a decision yet. The vote you’re talking about was the advisory panel that met the day after these recommendations were made. They don’t have to agree with the panel (although they often do).

      • Tara Caron Antonuccio

        Ok, thanks for clearing that up, Jim. I’d be surprised if they decide to keep the warning though…especially with time running out on the patent.