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Chantix, Suicide, and the Point of Prescription Drug Warnings

Quick poll: Think back to the last time you bought a prescription medication. Did you read any of the information about the drug printed on the papers inside the box? And if you did read it, did that stop you from taking the drug?

I can’t recall a time when I read any of that fine print, despite the fact that I’m fascinated by medicine and often write about it. I got thinking about the potency (or impotence) of these warnings this week while reading about a controversy surrounding Chantix, a drug that helps people quit smoking.

Chantix (Pfizer’s branded name for varenicline) works by stimulating nicotine receptors in the brain, thus curbing cravings for cigs. The Food and Drug Administration (FDA) approved the drug in 2006. Since then, a small percentage of people who take Chantix have reported neurological side effects, and serious ones: depression, psychosis, erratic behavior, even “feeling like a zombie.” The drug has been linked to more than 500 suicides, 1,800 attempted suicides, and the bizarre death of an American musician. Here are a few anecdotal reports about the drug from a Reddit thread:

  • Chantix was the most miserable drug I have ever taken…severe gi distress, depression, paranoia, crazy and vivid dreams, etc. BUT, it got me off cigarettes after everything else I tried had failed…As I knew that it really fucked with you I prepped by temporarily getting rid of the guns and having my brother check up on me daily…What keeps me from going back to smoking is knowing that one day I’ll want to quit again, and I NEVER want to experience Chantix again!!!
  • I’m convinced Chantix played a part in my divorce. My ex gave up smoking, her Pepsi habit, as well as marriage.
  • My mother was on it (and successfully quit smoking using it) and she had some outrageous paranoia. She would accuse us of conspiring against her, making her sick, not loving her, lying to her, stealing things (that she misplaced), turning the dog against her (da fuq??), trying to poison her and sabotaging her car…she smoked for 40 years and failed at quitting hundreds of times. Chantix did the trick somehow but made her nuts.

Yikes! Reading stories like that might scare me enough to think twice about the drug. But would the information in the package insert?

That insert has been the focus of the recent hoopla about Chantix. In 2009, the FDA decided that the Chantix insert needed a “black box warning” about the risk of neurological side effects (so named because this text is outlined with a black border). Here’s part of that warning:

Advise patients and caregivers that the patient should stop taking CHANTIX and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior while taking CHANTIX or shortly after discontinuing CHANTIX.

The black box is the FDA’s most severe safety warning. Pfizer fought it tooth and nail, citing several studies showing that Chantix is not associated with a higher risk of psychiatric problems. (If you want to read more about these studies and counter arguments from the FDA advisory panel, check out this excellent piece by John Gever at MedPage Today.) Earlier this month, the FDA confirmed that the warning would stay, and in fact suggested that it have even stronger language.

But… why so much fuss over these warnings, anyway? Does anyone actually read them?

There doesn’t seem to be a lot of research on that question, though the data that does exist suggests that some patients are more conscientious than I am. One report I stumbled on, surveying 1,500 patients from a community pharmacy in Germany in 2001, found that 80 percent always read the inserts. A 2007 study looked at 200 patients in Israel who were prescribed antibiotics, analgesics or antihypertensives. It found that just over half of participants read the inserts. And a 2009 study in Denmark found that 79 percent of patients “always or often” read them. On the other hand, a 2006 report of American consumers reported that just 23 percent looked at this info.

Even if patients are interested in reading those materials, they might not understand the information. A 2011 study asked 52 adults with a high-school education or less to read the package insert and similar materials describing an antidepressant medication. Afterwards, less than 20 percent could name the the rare-but-dangerous side effect of the drug. A report from the Institute of Medicine similarly concluded that drug labeling is a big part of why patients often use drugs incorrectly.

Studies like those have led some researchers to propose ways to make labels more useful to patients. But the reason Pfizer was so concerned with the black box warning for Chantix has little to do with consumer behavior. The company was worried because of the warning’s potential influence on doctors and their prescribing habits.

There aren’t many studies looking closely at the correlations between black-box labeling and prescribing patterns. But there are two notable examples that seem to suggest that the warnings have teeth. Remember the Vioxx controversy? Vioxx was a hugely popular anti-inflammatory drug that was pulled from the market in 2004 because of its risk of heart disease and stroke. After that, the FDA reacted by issuing black-box warnings for several similar drugs, leading to a “rapid decline” in prescriptions.

The other example comes from the link between antidepressants and suicide in children and adolescents. In March 2004 an FDA advisory committee reported on this link, and several months later it issued a black-box warning on all antidepressants. By June 2005 prescriptions for children and adolescents had dropped 20 percent.

To sum up, I was wrong: prescription warning labels, though flawed, actually matter to many patients, doctors and pharmaceutical companies.

As for Chantix… if you’re thinking of trying the drug to quit smoking, you might want to wait until results come back from a prospective clinical trial slated to end next year.

UPDATE at 11:50am: I added the sentence about the 2006 report on Americans’ use of package inserts. (Thanks, Kelly Hills!)

16 thoughts on “Chantix, Suicide, and the Point of Prescription Drug Warnings

  1. Apparently that decline in antidepressant prescriptions was followed by an actual increase in teen suicides:

    http://www.nbcnews.com/health/kids-health/black-box-warning-antidepressants-raised-suicide-attempts-n134896

    There’s the correlation and causation problem of course.

    I’ve seen another study I can’t find now, suggesting that the black box warnings may even prime people for a nocebo reaction, where merely knowing about possible side effects causes more people to experience them. As with placebo, it’s not clear whether there’s a real physiological response happening with a psychological mechanism, or people are reporting things that they might not have reported if they hadn’t been warned (so not actually increasing incidence, only reporting of incidence).

  2. You must not ever have had many problems with drug interactions! Not only do I routinely read the labels and the lengthy inserts, I usually Google the drug’s name. Doctors and pharmacists are far too rushed for me to rely on them for this kind of information.

  3. I always read the material carefully. Then I don’t take the drug. This has worked well so far. Since I avoid drugs (except alcohol and caffeine) pretty assiduously, I usually don’t have to fear drug interactions, but I have many horror stories about things that happened to friends and relatives. Of course I have had the good luck not to get hooked on nicotine, which I understand is the most addictive of all drugs, and may therefore require strong and dangerous countermeasures.

  4. I wonder if the apparent side effects of Chantix are actually the effects of withdrawal from nicotine ? I have heard some pretty bizarre stories from heavy habitual smokers who were quitting – including one who had serious thoughts about murdering his wife.

  5. My daughter killed herself while taking this poison. She had no history of psychiatric problems and was still smoking so it wasn’t from nicotine withdrawal. It also took a full year longer to have the black box warnings put on Canadian packaging so it wasn’t from the “nocebo effect.” Warnings say people on the drug should be monitored but my daughter was living alone when she mixed a bottle of aspirin and sinus medication into a protein shake and drank it. A full bottle of sleeping pills was left untouched. If you aren’t thinking straight, there is a good chance you don’t realize it’s caused by the medication. Taking Chantix/Champix is a game of Russian Roulette.

    1. I’m terribly sorry for your loss, Patricia. It must be an urgent calling for you to get word out about the dangers of this drug.

  6. I generally don’t read drug package inserts for ones I and my family have been prescribed, but I do generally do research via web searches and scientific paper searches, with plenty of skepticism. The inserts pretend to be more authoritative than you generally can be with drug side effects and they are extensively vetted by the drug manufacturers, who have obvious biases. They’re also not well written.

  7. I’ve used it and it worked pretty well with only minimal side effects. The only problem was that some time after stopping it i started smoking again.

  8. I took this nasty pill and it warped my brain it ruined my life I atempted suicide and feel as though this drastic change.in my brain via this pill played a huge roll. I am very sorry but I’m here to say stay away. My heart Dr told me to try it and I’m sooooooooooooo sorry I did . It may be able to help some but I am one to say that it didn’t help me to quit just made me crazy paranoid and am still dealing with its misery . Please consider other options cause it’s caused major trouble in my life I wish I could go back and have not ever been intoduced to this horrid medicine .

  9. i lost a woman i wanted for 15 years to that poison,my doctor would not treat me for a medical condition unless i quit smoking,even testing my blood for nicotine…i can easily see how some may commit suicide when on that trash,it turned me into a non responsive zombie…avoid it if possible,i still hurt from losing her because of my catatonic state of mind when i saw her for the first time in 15 years,try nicotine gum instead,what a prolonged painful nightmare for me,sorry 2 hear of others losses as well….also avoid acetaminophen staggered poisoning,you can die quickly from liver failure…4 doctors said nothing to me about that trash,especially combined with hydrocodone,evidently my doctors do not read…i died again….i am not a doctor,just a typical citizen of this country…someone tell moira i am sorry

  10. Yes, there are warnings about this drug, I read them before taking it and so did my husband. We planned on starting Chantix at the same time, but somehow I started it 4 days after him. This drug altered his state of mind to the point that he couldn’t even recognize that he was having side effects the warnings told us about. He was completely delusional, suicidal, hostile, having hallucinations and felt that something else was controlling his thoughts and actions.Thank God I was only on my first dose and could recognize it otherwise I’d have a dead husband right now from suicide. It took him several weeks to recover from this and feel back to himself again. The one dose I took, was the only dose I took.

  11. Chantix is the worst drug on the planet! My husband took it for ten weeks and has never been the same since. His doctor said he didn’t approve of the drug because it caused seizures in some people. My husband has had 7 seizures in the last 4 years. His personality has changed, he goes into rages and calls the police and tells them to take me away. Our relationship has changed, he doesn’t trust me anymore. We have known each other all of our adult lives. I’ve contacted several lawyers to help me but not one would take our case. Fighting Pfizer is just too much for them. I haven’t given up yet and still want to take these bastards down! I also know of two other people that have lost everything because of this drug. If anyone out there has any information on this or ways to get them please contact me

  12. I am supposed to start taking this medication today. I’ve been reading reviews for two days now and I’m absolutely terrified to start taking this. I am 38, have 4 daughters and a husband. I’m afraid of what this will do. Someone please help ? Any advice or suggestions will be greatly appreciated. Thank you.

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