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Reports Of Anti-Smoking Pill Chantix Causing Depression And Suicidal Ideation Made To FDA

Pfizer Increases Warning About Abnormal Behavior Of Patients Using Its Smoking Cessation Medication In January 2008

(Posted by Tom Lamb at DrugInjuryWatch.com)

On November 20, 2007 the FDA issued an "Early Communication About an Ongoing Safety Review Varenicline (marketed as Chantix)" to inform healthcare providers about reports the agency had received of people exhibiting various types of abnormal behaviors while using Chantix.  These reports included new-onset of depressed mood and suicidal ideation, as well as other unusual changes in emotion and behavior within days to weeks of initiating Chantix treatment.

In that November 2007 Early Communication item regarding Pfizer Inc.’s anti-smoking pill Chantix, the FDA recommended the following measures:

  • Healthcare professionals should monitor patients taking Chantix for behavior and mood changes.
  • Patients taking Chantix should contact their doctors if they experience behavior or mood changes.
  • Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

And in the closing part of that Early Communication:  "FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action."

Only two months later it was announced that the package insert, or label, for Chantix was getting a stronger warning about such abnormal behavior in people taking this smoking cessation drug.

From a January 18, 2008 Bloomberg report, "Pfizer’s Chantix Gets Warning Over Suicidal Thoughts (Update1)", we get these details about the announcement concerning the increased Chantix warning:

A possible link between the drug and reports of agitation, depressed mood and suicidal thoughts among some patients taking it can’t be ruled out, Pfizer said today in a statement. The behavior could be worse in people with a pre-existing mental illness, the New York-based company said….

"A causal relationship between Chantix and these reported symptoms has not been established," Pfizer said in the statement.  "In some reports, however, an association could not be excluded."…

An advisory about the symptoms was already included in the drug’s prescribing information under the "post-marketing experience" section. The enhanced warning will make the advisory more prominent to doctors and advise them to monitor for unusual behavior in their patients, Pfizer said. The drug was approved in the U.S. in 2006.

For those interested, we have provided links so that you can see how this new warning appears in the January 2008 Chantix package insert — in the new WARNINGS section — and compare it to the November 2007 version of the Chantix.

P.S.   On February 1, 2008 the FDA issued these two items concerning Chantix and the associated side effects discussed above:

Public Health Advisory; and,

Healthcare Professional Information Sheet.

We will continue to watch Chantix for further drug-safety developments.  (2/2/08) 

12 responses to “Reports Of Anti-Smoking Pill Chantix Causing Depression And Suicidal Ideation Made To FDA”

  1. Roy Avatar
    Roy

    I took chantix and I became suicidal, homicidal and very paranoid. Wanted to take my life and did not know why. Quite the chantix and all the side effects went away and I do not drink. Now having health issues a month later after using chantix and quit smoking for two months on own .Such as pains in back around lung areas, chest, and headaches.Maybe health issues due to long time smoking. Never had while smoking now all of a sudden I do.

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    I appreciate you sharing your experience with Chantix.
    Hopefully you have spoken with the prescribing doctor, or some other doctor, about the various possible Chantix side effects.
    If you want, you can submit a MedWatch report to the FDA to let them know about your experience with using Chantix. Here is link to a page on our web site that will let you know how to do this:
    http://www.druginjurylaw.com/medwatch-report.html
    I hope your condition improves with time.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. Nikki Gibbs Avatar
    Nikki Gibbs

    I took chantix for a 2 month period and while i did quit, i became very depressed suicidal and did even attempt an over dose, i was paranoid and even at times thought i was having a sort of duel personality problem, it was a very disturbing time for me and i am still having issues with this.

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    Nikki:
    I appreciate you sharing with us your experience using Chantix.
    Some lawyers are investigating possible Chantix lawsuits; my firm, however, is not involved with those cases.
    We wish you the best going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  5. Gretchen Avatar
    Gretchen

    I was taking Chantix for a month and a half. I have no history of mental illness, but within 2 weeks I became very depressed, mentally disorganized, and paranoid. I felt as though I couldn’t concentrate on anything. These changes were sudden and intense, so I quit taking Chantix, but I did not wean myself off of the pills. By quitting Chantix cold turkey, I felt like I had a 2 week tequila hangover. I would recommend taking with a doctor about weaning yourself off the medication.

    Reply
  6. Tom Lamb Avatar
    Tom Lamb

    Sharing this information concerning your use of Chantix — in particular, the way you stopped and what you recommend, instead — should be valuable to other people using Chantix, now, or considering to do so, or not, in the future.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  7. Steve Avatar
    Steve

    I have been taking Chantix for 2 weeks and less a little stomach ache that lasts about 5 minutes I have been fine. I have quit chewing, but now I am thinking of quiting Chantix early…

    Reply
  8. Tom Lamb Avatar
    Tom Lamb

    I appreciate you letting us know about your experience thus far with Chantix.
    I hope you can stay “quit” once you do stop using Chantix.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  9. Richard Avatar
    Richard

    Fortunately I survived the deadly side effects of Chantix manufacturer Pfizer. Its smoking cessation drug. What’s a few lives or disabilities when Pfizer is pulling in billions from the American public, or the world for that matter. Sure tobacco is slowly killing people slowly after many years of use. However Pfizer, with Chantix can finish the job in just a few short days. After trying this deadly product for 10 of the 12 week program I ended up in the emergency room with a catheter in my heart and consequently spent the 2007 holiday season in the hospital. Many Americans are treated for thyroid conditions and as I found out the hard way this will block that medication as well. I still have not seen any warnings about this interaction. How well was Chantix tested? Only the public will find out if they survive. For people thinking of trying this product please beware.
    The anti-smoking system, a 12-week program that diminishes cravings for nicotine by blocking targeted receptors in the brain from receiving nicotine, thereby mitigating the release of pleasure-loading dopamine, has been the subject of intense scrutiny and media attention since coming onto the market amidst much fanfare just a few short years ago.
    However, an alarming parade of adverse effect reports, including aggression, depression, suicidal thoughts and actual suicides, has raised the red flag. While Chantix remains on the market, the US Food and Drug Administration (FDA) is continuing to investigate, and is advising doctors to carefully monitor their Chantix patients, as well as carefully determine the suitability for patients considered candidates for Chantix.
    According to the report the number of adverse events linked to Chantix rose from 700 in the first three months, to 3,700 at the conclusion of the nine-month data window. What is most disturbing is the number of attempted suicides, up to 18 from zero in that same interval. The data, when broken out, demonstrates a trend that shows suicidal thoughts nearly doubling every three months throughout 2007.
    Chantix, and it’s UK counterpart Champix, first came onto the market in August of 2006 after completing the requisite pre-market trials which test the product on a small cross section of patients thought to be a statistical representation of the wider population. However, it has been reported that those trial participants were carefully chosen, and those individuals with serious physical, or emotional issues or conditions were weeded out.
    It has also been reported that trial participants received weekly counseling sessions, something most people in the real world would either not have access to, or could ill afford.
    For its’ part, Public Citizen put Chantix on its ‘Worst Pill List’ early on, and advocated that Chantix be curbed for seven years, as it is the time, according to a Public Citizen spokesperson, that it takes for the true merits, or risks of a drug to come into view.
    Sure enough, the media and the Internet have been rife with stories, and reports of Chantix users experiencing a wide range of adverse affects, some of them serious—and the most serious of all, suicide ideation.
    Initially, Pfizer listed the five most common, and relatively minor side-effects on the product label, but reserved the more serious adverse effects for a product insert, produced with fine print, that was meant for doctors and medical professionals. Here, is where language articulating the potential for depression, aggression, and suicide ideation could be found.
    That has since changed, as Pfizer updated the warning on the Chantix box in January.
    It now warns all patients be observed for potential neuropsychiatric symptoms, including among other things, suicidal behavior.
    However, Public Citizen is not satisfied. It wants the strongest warning possible—a black box warning—for a drug that has been allegedly found to be at the root of so much hurt and injury, and even death.
    In the 18 months since Chantix came on the market, it has been embraced by millions of Americans desperate to quit smoking. In their wake, are the scores of Americans trying to quit Chantix. If indeed, it isn’t too late.
    Pfizer, for its part, stated that in its view post-marketing data is inconclusive. Further, the manufacturer continues to believe in the safety, and efficacy of Chantix. Pfizer also stresses that it has worked closely with the FDA in updating product labeling, and reminds us that smoking remains the leading preventable cause of disease and premature death in the US, with more than 438,000 deaths annually, attributable to smoking.
    Still, drugs promoted as helpful should not help you to the hereafter. Those having experienced injury, or the loss a loved one not to smoking, but to the effort to quit smoking via Chantix, may be well advised to seek legal counsel.

    Reply
  10. Tom Lamb Avatar
    Tom Lamb

    I appreciate you taking the time to share your experience with and thoughts about Chantix.
    Hopefully your information will save someone from going through what you did when using this increasingly-apparent unsafe drug.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  11. mary Avatar
    mary

    Iam a stubborn person and I took chantix three times. The first time I was successful for a month and a half. I thought I could smoke just one. Well since then I tried to use chantix two times since and both times I became so mentally confused and unsure of life, I had to stop the medication. I wanted to die. I was so paranoid this last time I wouldn’t come out of my house. Something was different about me while taking the chantix and almost cost me my life trying again for a third time. I refused to believe it was the chantix, no doubt in my mind it was that drug. I never felt so uneasy in my life. The first time I took chantix I became depressed and irritable, I blamed it on everything else, but lost a three job I loved after being on the chantix. This last time I have no doubt the chantix has some kind of very dangerous negitive affect on my brain. I was scard to death this time but relizing it is the chantix, I felt better and more hopeful there was a reason. I really thought I was going out of my head. I also had terrible pain in my liver and stomach for about 15 minutes after taking the chantix. I am a nurse and worked in the counseling feild and I have no doubt about the chantix being potentionally dangerous to some. I won’t chance it again and try to take it again. I’ll keep praying. Mary

    Reply
  12. Tom Lamb Avatar
    Tom Lamb

    Mary:
    I appreciate you taking the time to share the details of your serious apparent side effects and unfortunate experiences while using Chantix.
    Hopefully your information will benefit someone else who may be going through difficult times while using Chantix and wondering what is going on with them.
    I wish you the best in all aspects going forward.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply

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