Chantix Effects Not Tested on Mentally Ill, Despite FDA Suggestions: Report

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According to a new report, both Pfizer and federal regulators ignored calls for the smoking cessation drug Chantix to be tested on users with mental illnesses. Critics now argue that such pre-market testing may have revealed the serious psychological Chantix effects, which have allegedly resulted in hundreds of suicides and suicide attempts. 

According to a report issued by, Pfizer won approval to market Chantix in 2006 through an expedited process over the objections of some of the FDA’s own drug safety reviewers, who said that the drug should be tested on people with psychological problems.

A disproportionate number of smokers suffer from depression, anxiety and other psychological issues, yet the report suggests that Pfizer did not adequately test the side effects of Chantix on this population of potential users.

Chantix (varenicline) was approved by the FDA in 2006 as a prescription medication to help people quit smoking. The drug works by reducing the positive feelings that come from cigarettes, blocking the receptors in the brain commonly stimulated by nicotine. However, the drug has been linked to increased risks of suicide and suicide attempts, aggressive behavioral changes and other psychiatric side effects, which have resulted in fatal or catastrophic injuries for many users. Since Chantix was released it has been linked to nearly 100 suicide deaths, 200 attempted suicides and 5,000 psychiatric events.

Officials from the FDA and Pfizer deny that there were any missteps in the approval process for Chantix, despite the fact that the FDA ordered Pfizer to conduct clinical trials on the mentally ill in 2009, three years after the drug was approved. As early as 2008, some attorneys investigating Chantix suicide lawsuits raised questions about why the drug had not been tested on people with psychological problems.

The FDA has received hundreds of adverse event reports involving Chantix problems, leading to a “black box” warning being added to the medication in June 2009 about the potential psychological side effects. Following the rising tide of suicide reports, the FDA ordered the new clinical trials in hopes of gaining more data on how often neuropsychiatric symptoms with Chantix occur and what conditions cause them.

A growing number of individuals throughout the United States have filed a Chantix lawsuit against Pfizer. All of the complaints involve similar allegations that Pfizer failed to adequately research the effects of Chantix or warn about the increased risk of unusual and aggressive behavior, such as suicide and unexpected acts of violence.

The federal Chantix litigation has been consolidated as part of an MDL, or multidistrict litigation, for pretrial proceedings before U.S. District Judge Inge P .Johnson in the Northern District of Alabama. The parties have been directed by Judge Johnson to submit a joint proposal by February 1, 2011 regarding the process for selecting a pool of initial cases that will be eligible for case-specific discovery and trial, if necessary.

These early cases, which are known as Chantix bellwether lawsuits, are used to help the parties gauge strengths and weaknesses of their cases, and may lead to an eventual Chantix settlement or other resolution for the litigation.

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1 comment

  1. terri Reply

    Finally…finally…Chantix’ side effects are coming to light. It’s been a long time coming for those injured/affected early on.

    Please note: I took this drug in good faith and with only the BEST intentions!! I did NOT take two complete scripts w/in a year… with the hopes of having a bad reaction and taking an early retirement. I did not WANT to partake in two hospital stays, a psyche unit, intense outpatient therapy for past 2 1/2 years and wake up when being taken off a ventilator…six days after ingesting 240 sleeping pills…and cutting self w/razors…surrounded by devastated/confused family members. What the…?!

    I was a “steady eddy” when I started my first chantix regimen in Oct. ’06. Age 55, married 37 years, mother/nana of six, working at a job I’ve loved for past 23 years…lots of friends and large family…silly siblings I love getting the giggles with….very active – – playing softball in senior league, love to walk, sunbathe, read, snowcones, barbecue, juming on the tramp w/grandkids….loved my life. Just wanted to make it even better by putting the habit to rest. Almost put myself to rest instead.

    Feared drugs as a teen. At 55, can describe a hallucination. Months prior to my “attempt” deceased loved ones came to my room at nite trying to convince me my job was done here. They were so happy, healthy and ended our meetings w/strong, solid hugs. I could’ve SWORN it was all real. In fact, got to the point couldn’t decipher reality from hallucinating/dreaming. I was so confused…so terribly, terribly tired.

    Jan. ’08
    Taken by ambulance middle of nite w/heart attack symptoms. Stayed a week, rleased w/diagnosis – – possible virus.

    May ’08
    Daughter called one day after work…says, “mom, what’s wrong? You’ve changed…people are talking…hmmmm…really? Laughed, picked up keys, took long drive to rural area, parked on an angle on used car parking lot…wrote short note, “it’s been real…” which was found by police the next morning when I was found…unconscious and unresponsive. Taken to little country hospital, put on life support, family and work was notified, and the nightmare is just now ending. All rights were stripped, driving, babysitting my beautiful grandbabies, credibility…GONE…just like that!

    I never would’ve put Chantix in the equation. No one knew I was on it! Only my mom knew. She started to feed me negative articles and I finally took notice. O…M….G….could this POSSIBLY NOT be my fault???!!! Could I really not be a crazy person???!! Can a drug alter a person’s mind…so completely….sneakily…slowly….and THOROUGHLY????!!! But, it was FDA approved!! They wouldn’t put it out there if it wasn’t ok!!! My doctor likes me….SHE wouldn’t want to hurt me!!!! What the hell happened???!!!!!!!

    How MANY people have been injured, died by their own hand, behaved violently/hatefully…not even KNOWING WHY their ways of thinking are soooo distorted?????!!!! UNEXPLAINED ACTS OF VIOLENCE, SUICIDES, WEIRD THOUGHTS, ETC….CAN MAYBE NOW BE EXPLAINED!!!!!!! Everyone who filled a Chantix prescription has a right to know about the VENOM that flows thru their veins. Surviving family members and loved ones deserve to know HOW/WHY a member committed suicide….the drug takes over your mind and believe me, suffocates any happy vibes you may have.

    To live seems pointless…almost funny!! I don’t remember feeling sad, mad, glad, etc….just flat. And tired. Very, very tired. I pray…along w/so many others for my day of vindication.

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