Chantix & Violence: What Patients Have In Common
8 CommentsBy Ed Silverman // July 22nd, 2010 // 8:42 am
For the past three years, the Chantix smoking cessation pill has caused a stir after being associated with suicidal behavior and vivid dreams (see here and here). Consequently, the government banned the Pfizer drug for pilots and licenses wouldn’t be issued to truck drivers taking the med (see this). The FDA subsequently imposed a risk management program and Pfizer added warnings.
Now, a new study in The Annals of Pharmacotherapy finds Chantix is not only associated with violent and agressive thoughts and acts, but has also identified some of the common characteristics among people using the pill and their subsequent behavior. The drug “does have warnings about psychiatric side effects, but it skims over aggression/violence towards others to focus mainly on suicidal behaviors,” says Thomas Moore, one of the co-authors and a senior scientist at the Institute for Safe Medication Practices, a non-profit that has issued reports previously about Chantix side effects.
“We believe this may be the first scientific report to examine the characteristics of aggression/violence as a psychiatric side effect for any prescription drug. What do these cases look like? A question answered for possibly the first time. We found the details striking and chilling. This is the first time we know of that aggression/violence has been clearly documented as a side effect in a peer reviewed scientific journal. This raises the question of whether (Chantix) is suitable for use in the military, by police and others who are already in stress situations. One key characteristic of these events is uncontrollable rage. Not a good side effect for people paid to carry guns.”
The researchers obtained 78 adverse event reports from the FDA MedWatch database containing medical terms describing possible acts or thoughts of aggression/violence; four more cases came from clinical trials, and three others came from published literature. Ultimately, they used 26 case reports for study and these described 10 events with assault, nine cases of homicidal ideation and seven instances of other thoughts or acts of aggression/violence. They noted that the patient population was predominantly middle-aged women, but “an unlikely age group and sex for assault and acts of
violence toward others.”
“In all 26 cases,” they write, “the acts or thoughts of violence appeared to be inexplicable and unprovoked. A woman struck her 17-year-old daughter in the mouth while the daughter was driving a car, with a young granddaughter also present. A 42-year-old man punched a stranger at a bowling
alley. The stranger and two friends responded and kknocked out the subject’s front teeth. A 24-year-old female started beating her boyfriend in bed because he “looked so peaceful” and she later attempted suicide. A 29-year-old female struck an acquaintance twice in the face, and then started smashing doors in her own home and beating on her truck.” (Take a peek at Table One).
And how about those common characeteristics? The most frequent ones inexplicable and unprovoked
events; the victim was anyone nearby (a boyfriend, spouse, child, neighbors, a policeman, coworkers, acquaintances and strangers); there was no indication of a prior history of similar behavior and early onset of psychiatric adverse effects, often before stopping smoking.
A Pfizer spokesman says the drugmaker could not immediately comment, but is reviewing the study.
UPDATE: Pfizer sent us this statementA: “Pfizer takes the safety of all of its medicines seriously. All post-marketing reports of adverse events are reviewed by Pfizer, and reported to regulators, including FDA. The currently approved Chantix label contains a boxed warning regarding reports of serious neuropsychiatric events reported in some patients. If these neuropsychiatric symptoms are observed by the physician, patient or caregiver, patients should stop taking Chantix and notify their healthcare provider immediately. There is no reliable scientific evidence demonstrating that Chantix causes these events.”
In discussing the limitations of the study, the researchers ask if the behavior can be attributed to a withdrawal syndrome from stopping smoking rather than the effects of the drug. But they argue this is unlikely, because the initial onset of adverse effects in 89 percent of the patients occurred in the first week of treatment before they reached a target quit date. And they rarely found similar behavior in patients who used nicotine replacement products, according to their review of Medwatch reports. Nonetheless, they believe, “it appears likely that these events occur typically in a relatively small and susceptible population that is affected early.”
By the way, the authors reported these conflicts: a portion of the research was performed under consulting contracts by Moore and Joseph Glenmullen, a clinical instructor in psychiatry at the Department of Psychiatry at Harvard Medical School, with the US Army Trial Defense Service in connection with expert testimony in a criminal case. The Army had no involvement in the conduct, design, or conclusions reached, they write. And Glenmullen has been retained as a potential consultant in legal cases involving the drug.
ol cranky
hmmm, how long before we hear Mel Gibson was using Chantix to quit smoking?
John Q
How long before the FDA pulls this deadly drug from the market? How long before cessation “experts” quit accepting pharma money to promote this novel drug? There are many questions “ol cranky”, and I can assure you that none of them are funny!
ChampixSucker
I took Champix in March of ‘08 and I am still suffering from most of the side effects of this poisonous drug. I started to feel some of the bad effects (nausea, mental fog, trouble sleeping, sore eyes, constipation, gas) of Champix while taking it but I was determined to quit smoking. For the first month I felt exceptionally good and I was telling everyone how great it was but the euphoria came crashing down and I went into a deep depression. I was able to make it through the full 3 month course but when I stopped taking it is when I really got messed up. I developed Psychosis NOS, Major Depressive Disorder, suicidal, Emotional instability, aggression, INTENSE rage, panic attacks, hallucination, Somatoform Disorder, Delusional Parasitosis (bug crawling sensations all over my body), Cholinaergic Prurritus, Hyperacusis (sensitivity to certain frequencies of sound causing severe pain and pressure in my ears), Severe Insomnia, Memory Loss, Brain Fog, Lowered Inhibitions, Hair was constantly hurting all of the time and lost lots of it (27 year old male), Irritable Bowel Syndrome (started as extreme constipation and gas, fatigue, Severe Eye pain, unsightly puffy bags under eyes, excessive weight gain, gingivitis, prostate pain, frequent urination, black out and become out of control when drinking, decreased sexual pleasure and ability to maintain erections. I think that is everything!!! I went to the psych ward recently due to being suicidal and at a breaking point with my symptoms and I was treated like scum and given brain damaging neuroleptic (anti-psychotic) drugs against my will. I have made some small improvements since taking Champix but it looks like the nightmare will never truly end. If you are one of the many that gets burned by this medication be warned that the doctors will probably not be able to help you and will most likely deny that anything is even happening to you or that it is related to Champix and the side effects may be permanent. I had a similar reaction in respect to rage and disinhibition from taking Zoloft when I was younger which altered my life substantially and now Champix has put the nail in the coffin. Apparently these two drugs have a similar mechanism but Pfizer with held this information and marketed the drug in a deceiving way not mentioning any of the neuro-psychiatric and mind altering side effects of the drug when it first hit the market in order to boost sales of their poison. The medical community has know for quite some time that dopamine plays a role in mood regulation and the fact the Champix targets the “pleasure centre” of the brain makes them grossly negligent for not investigating this further and informing consumers. Many people including myself (I turned down a prescription of Zyban due to my experience with Zoloft) would not have taken it if we would have been informed of the risks and Pfizer knew that. SHAME ON THEM FOR RUINING MY LIFE AND MANY OTHERS INCLUDING THOSE WHOM ENDED THE MISERY BY TAKING THEIR OWN LIFE.
YOU’VE BEEN WARNED
Jennifer
I would love for my brother to stop smoking would never recommend this product to him now that I know how severe and dangerous the side effects can be. The best way to quit is never to start in the first place. Here is another article from a wellness site about the Chantix side effects and a more natural approach to quitting…
Madelene Smullen
Thank you for enriching the On the internet entire world with this post!
Leslie
So although I’m not a big fan of Pfizer or other big pharma companies generally, I just cannot honestly thank Pfizer enough for development of this particular medication.
I took Chantix for almost 12 months after smoking for approximately 45 years and trying unsuccessfully to quit thousands of times. Chantix was my last best hope! Yes I had vivid dreams, but they were “fun” type of dreams. I never experienced uncontrolld rage, anger, depression, any of those things.
Interestingly, I note that the study into these side effects is from a very small population compared to the very large number of persons who have been prescribed and have taken this drug with great success, including me. Maybe I’m just lucky, I don’t know. I’ve been off the drug now for 4 months and am no longer nicotine dependent. Nor am I depressed or angry or rageful or anything else. All I am now is an ex-nicotine addict!
I am so thankful for this medication because no other therapy worked for me. Nicotine replacement, if you ask me, is a joke. And, if you want lack of effectiveness, look at the NRT statistics of who remains nicotine free following quitting, if they really quit at all, with NRT. I even became addicted to the nicotine nasal spray and those Commit Losenges. It was awful, replacing nicotine with nicotine and got me nowhere.
Also, if one really wants to know something about the effect this drug has on those using it, go check out a website called “Quitnet” where, among other clubs on the site, there is a Chantix Users Club. Quitnet has absolutely nothing to do with Pfizer or any other pharma company. Admittedly, there were and have been a few persons I’ve associated with on the Quitnet website who suffered from depression and other maladies associated with Chantix — but the discussions in the forums show that far more persons have been successful in their efforts to quit smoking because of the help Chantix delivers as compared to those who unfortunately suffered side effects.
So for those of you working to keep this drug off the market, or taken off the market, in my humble opinion, you will be doing society a huge disservice and you will actually be promoting continued tobacco usage, with side effects significantly more serious like cancer, heart disease and COPD — not to mention the affect of smoking on other organs, not to mention the human brain.
In my humble opinion, at this time, a risk benefit analysis should keep this drug available to those who can take it without the unwanted side effects unless and until a larger study could be conducted that justified it being withdrawn from the market. Otherwise, it should be allowed for those who can take this drug without all these side effects.
Virginia Lee
When will Pfizer be made to release the post marketing clinical trials? None of the ones associated with mental health have results published even though they were completed long ago. There is proof and it is in Pfizers hands. When will someone step up to force them to be honest to the general public for a change? I do not care if they are the FDA’s biggest customer. We need answers before chantix turns our own citizens into time bombs. Violence was included in the initial information but is not now. Why? $$$
TERRI
Virginia, I’m with you.