On January 3, David Collins killed himself with a shotgun, three months after he began taking Chantix, Pfizer's controversial smoking-cessation pill. Now, his widow, Linda, has filed what may be the first product-liability lawsuit against the drugmaker over Chantix side effects and an alleged failure to provide sufficient warnings. And her lawyer predicts many more such lawsuits are on the way.
In her lawsuit, which was filed in federal court in Indianapolis, Collins claims Pfizer failed to adequately study Chantix; delayed publication of studies containing Chantix risk info; failed to update Chantix labeling sooner, and denied Chantix is explicity to blame for suicide by instead suggesting such behavior may be the result of nicotine withdrawal. Here is the lawsuit.
"The magnitude of the safety signal associated with the risk is alarming," Kristian Rasmussen, one of Collins' lawyers, tells us. Prior to the suicide, David Collins exhibited aggression and had strange dreams, but had no history of mental illness. Pfizer has been criticized for not including people with mental illness in its clinical trials, because the drug causes neuropsychiatric side effects.
You may recall the FDA, last February, issued a health advisory about Chantix concerning ties to the side effects, shortly after Pfizer upgraded the labeling. At the time, the FDA reported 39 suicides and 491 cases of suicidal behavior or thoughts.
Since then, the Institute for Safe Medication Practices issued a report showing nearly 1,000 serious side effects of various sorts were reported concerning Chantix, prompting federal agencies to ban use of the drug by pilots and truck drivers. Pfizer responded with a publicity campaign.
A Pfizer spokesman send us this statement: "Pfizer is aware that a lawsuit has been filed in federal court in Indianapolis, Indiana, but we have not been served with a copy of the complaint. Pfizer will file a formal response to the lawsuit at the appropriate time.
"Pfizer believes that it has acted responsibly, appropriately and in the best interests of patient safety at all times in connection with its smoking cessation aid Chantix. Approximately 7.5 million people worldwide have taken Chantix since its approval in 2006.
"Pfizer reviews the risks and benefits of all of its products, including Chantix, on a continuing basis. Based on Pfizer’s review of the available safety information, including certain neuropsychiatric adverse event reports received to date, we believe the Chantix label accurately reflects the product’s efficacy and safety profile, thereby facilitating appropriate use by physicians and patients. It’s important to note that a causal relationship between these reports and the use of Chantix has not been established."
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http://www.psychdrugdangers.com/VareniclineSuicides.html
232 cases of suicidal ideation, 6 attempted suicides and 29 completed suicides were reported to the FDA's MedWatch system in late 2006 through 2007 where Chantix was identified as the Primary Suspect Drug. Also included were numerous reports of suicidal ideation dechallenge (dechallenge is the medical term for an adverse reaction abating or ceasing when a medication is stopped).
It really is amazing how Pfizer would like everyone to believe suicide is a normal behavior from nicotine withdrawals. Even when you commission top smoking cessation experts to reiterate the safety of this drug over and over, it does not actually stop the AEs from occurring.
Pfizer is so stuck on that magic number of 7.5 million worldwide that apparently a few people(to them anyway)do not matter. There was a delay of neuropsychiatric events being reported after use of this drug, and even now these reports are questioned.
This legal action was only a matter of time.
I would like for some of you doctors to tell us if they have ever prescribed chantix to there family members.{In the last six months} If this is so safe.. why do they not alow pilots and truck drivers to take this medicaction. Are there lives more important than others? The V.A. is looking in to the problem of suicide while on this drug also. How many of our troops have died from complications from Chantix,that have blamed on other things.I can not wait to see the law suits.. I have lost my brother to this drug. This drug is very dangerous...CHANTIX...Killed my brother..
Looks like we have another Paxil scenario all over again.. Very sad that peoples lives are seen as just statistical..
I took Chantix last November. During the first week, I had nightmares, confusion, weird thoughts, hallucinations, and suicidal ideations. Then I started having seizures, (I immediately stopped taking the medicine). Suddenly, I could not work, I could not drive,and I was fearful that the effects of this drug were permanent. I had to call my parents to come and help me with my four children. After many years taking care of them, I could not function because I was in no shape to take care of myself, let alone the children. I have had problems convincing my doctors that Chantix had a role in my unusual behavior. I still think that everybody should stop smoking However, taking this medicine while having public safety responsibilities is very risky, at best.
Were you taking any antidepressants while taking Chantix?
Hello my name is Garland McLaurin, I'm am working on a story about the issue of Chantix and suicides. I would like to talk to anyone effected by the drug. Please email me at gmclaurin@newsproject.org so that we can talk, I would love to talk to James R and Doug Collins on the message board.
I doubt my husband will talk to you, but I can email you. My husbands dr prescribed Chantix some time last year. After only about a month, my husband started having crazy dreams, suicidal thoughts (he won't tell me that's what it is, but he says it in so many words) and his attitude is horrendous. We just want something to take the effects away.
Robert Wood Johnson Foundation, Marketing arm of Johnson and Johnson pharmaceutical and its surrogates; American Cancer Society, National Lung Association, and American Heart Association work very hard at convincing the American public of the dangers associated with smoking and Secondhand Smoke. They do this in order to sell their cessation drugs, without telling the dangers associated with the drugs.
When I began taking chantix I started having strange vivid dreams. However I already knew that was a side affect, along with the increased risk of having suicidal thoughts. While on the drug the funniest thing happened I QUIT SMOKING. So I guess the drug works like it's supposed to. I am sincerely sorry to those who have lost someone who was taking the drug. However the side affects are well known and not kept secret, and any time someone chooses to take a new medication they should find out from their doctor all the possible side affects or drug interactions then choose whether or not to take it.
About a week and a half ago, I started taking Chantix in an attempt to stop smoking. During the first week I experienced agitation, but I kept taking the medication thinking it was a side affect and would go away eventually. A couple days, I could not stop crying. I felt so worthless, like I could not do anything right, everything depressed me more so than usual (I have bipolar disorder) and although I take four different medications for my disorder, the Chantix totally took over my mood and I started having thoughts about suicide that before I would of never ever have I lost a boyfriend to suicide last year and I saw how it affected those left behind, myself and my child included, and the thought would of never crossed my mind until I took the Chantix. It is dangerous and should be banned, expecially to people with existing emotional disorders. Also, I have not even slowed down smoking, it is not working as far as my smoking goes, I still smoke as much as I normally do. Do not take this medication, it is not worth it. There are other ways to quit, herbal remedies that don't have such wicked side effects that could lead to a tragic event that isn't worth it. I would rather smoke for now until I find something safe to take than feel so depressed that I feel like I cannot go on.
I almost killed myself while taking chantix. It is a shameful secret I carry with me. I was only on the drug for about two weeks. Please do not let anyone you love take this drug.
I Just got out of the hospitol. On chantix for just over 3 weeks. I died. I have 2 children. I was put on life support. The medical staff revived me after 18 hours on support. My children were taken from me because of the suicide attempt. I have no prior history of this kind of problem. I was ill informed. My life has been turned upside down because of this.
We live in the UK where Chantix is known as Champix, and still prescribed to NHS patients who are depressed
My husband and I stopped smoking with Champix, back in November 2010. Unfortunately, our stop smoking specialist did not take into account that my hubby had depression and was taking 50mg Sertraline each day. He had also had a recent one week course of steroids for a chest infection and a course of antibiotics. On 6 December he had his first psychotic episode. It was devastating to see my quiet and loving husband turn into an argumentative tyrant, refusing to reason and physically threatening me when I took him to hospital.
He had more episodes during December and I began to research Champix, among friends and on the internet. I quickly realised that people with a known history of depression should not take the drug. We both stopped taking Champix after I realised that my husband was having more episodes and his behaviour was getting more bizarre. He began to lose huge amounts of short term memory and our GP refused to let him drive.
I cried for him on Christmas Day. He was so sad and his speech was slurred and incoherent. On Boxing Day he refused to believe he had experienced such feelings, so I filmed one of his episodes. He was distraught when he saw how angry, irrational and unpleasant he was. He cried when he became aware of the stress this placed on me.
Further psychotic episodes occured in January and our GP referred my hubby to a Neurologist. By February I became increasingly fraught with the snailpace of the NHS, so I demanded a mental health assessment be made. Hubby has finally been allocated an appointment with a psychiatrist.
His symptoms have now subsided and it has been over 3 weeks since his last episode. Yes, we are both smoking. It would have been impossible to endure the last 3 months battling with this confusing illness without going cold turkey.
I have no idea what the immediate future will bring, but, I would never recommend Champix.... particularly if there is any history (past or present) of depression
Drugs are not needed to stop smoking. Smokenders has highest success rate of all approaches. I used them to quit 30 years ago and haven't had a smoke since then.
http://smokenders.com/