Pfizer Strengthens Suicide Warning On Chantix Label
24 CommentsBy Ed Silverman // January 18th, 2008 // 9:22 am
The drugmaker updates the label to reflect ongoing concern that the anti-smoking drug is connected to suicidal thoughts and behavior.
You may call last November, the FDA began reviewing cases of suicidal thoughts and aggressive and erratic behavior in Chantix patients that were received from Pfizer, along with a number of reports from the media and internet sites. At the time, the agency wrote on its web site that “preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation and changes in emotion and behavior within days to weeks of taking Chantix.”
And so today Pfizer says its updated label includes a warning “that patients who are attempting to quit smoking with Chantix should be observed for serious neuropsychiatric symptoms, including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.” No figures were immediately available on cases reported.
A notable example, however, that drew national attention to Chantix was the case of Carter Albrecht. While in a drunken rage, the Texas musician banged on the door of a homeowner, who feared an intruder, and shot and killed the young man. Although Albrecht was later found to have tested for a high level of alcohol, he’d also begun taking Chantix, the smoking-cessation drug, a week earlier and complained of vivid dreams. Hallucinations are noted as only a rare psychiatric disorder, but “Chantix dreams” were cited by Albrecht’s family and girlfriend as possibly contributing to his outburst.
The FDA, meanwhile, had asked Pfizer for on additional cases that may be similar. The agency is “currently evaluating the material Pfizer submitted in response” as well reports of drowsiness in people taking Chantix who had difficulty driving or operating machinery. We are awaiting an update from Pfizer concerning the info provided to the agency.
Lisa Van S
This can be seen as an honorable move,..And refreshing to see.
Brian
I agree..good luck to folks who want to quit!!
Laurie
Good for Pfizer.
henry
good for the regulators. pfizer were put under pressure.
Justice in Michigan
Pfizer’s reporting is mandated by FDA regulations. Any stronger warning comes from FDA, not the company. So far, then, Pfizer can only be congratulated for not committing felony fraud.
Atlex
Justice in Michigan,
Your characterization is not quite fair or accurate. Label changes typically involve a negotiation between the FDA and the manufacturer. In many instances, no matter the seriousness of the AE, that process can take many months. Considering how quickly there have been multiple updates to the label (remember there was a change to the label in November), it is highly likely that Pfizer is collaborating with the FDA to ensure rapid reporting of AEs and, subsequently, developing label changes in an expeditious manner.
This is particularly interesting because the label change suggests that the AE concerns have yet to be proven as caused by Chantix; instead, it looks as though since causality could not be dismissed, the decision was made to be as transparent as possible. I’m not suggesting that this deserves high praise, but combining it with Pfizer’s transparency around torcetrapib just over a year ago and this situation, it looks as though Pfizer is becoming increasingly transparent in its public actions. That is certainly not a bad thing.
Justice in Michigan
Atlex - Thank you; I stand corrected. I had misread the original piece and did not see what I think you rightly describe - it does appear that Pfizer is taking some initiatives here.
If this represents the future - as I hope it does - I would be less concerned about FDA preemption.
Lisa Van S
Atlex,
For me,.. Its the Zoloft that comes to Mind. Again,.. I believe Pfizer did an honorable thing by being transparent on Chantix.
henry
After WFAA-TV in Dallas reported musician Carter Albrecht’s violent death–perhaps under the influence of Pfizer’s smoking-cessation drug Chantix–more than 5,000 complaints about the med’s side effects poured into the FDA. And the complaints were serious: 55 reported suicide, 199 reported suicidal thoughts, and 417 complained of depression, according to the TV station, which obtained the reports. Hundreds of others mentioned anger, aggression, amnesia, hallucinations, and homicidal thoughts.
Pfizer did the right thing but did they have a choice?
5,000 complaints is a lot. Sure the FDA weren’t happy, extra work for them.
Bad publicity– so deal with it with a bit of good publicity and what do you know Pfizer is a feel good company. Things are looking up!
Atlex
Henry, there are a number of issues with those complaints. Self reports in general are difficult to assess. A single very public incident can generate far more self reports of possible side effects than would nornally be expected. Moreover, without investigating, it’s hard to know what is a drug AE and what’s not. For instance, 55 suicides sounds like a lot, but given that hundreds of thousands or millions of people are using the drug, does that number differ dramatically from what might occur in population of that size, particularly one that is more susceptible to depression and anxiety (smokers and those trying to quit). The mentally ill tend to have high smoking rates and smoking cessation, itself, causes many of the effects reported above. Working through all of these issues is complex and can be very time consuming. The key here, as reported in the press, is that not every report to the FDA involved patients who had ceased smoking and, thus, a link to the drug seemed possible. That’s why the FDA and Pfizer made the decision to update the warning.
henry
I understand, but a company has to expect self reports, after heavily marketing a smoking cessation drug to the general public that appears to have side effects usually reserved for patients with mental health issues. It is a gamble they took. However the reaction from the public was too strong and could not be ignored by the FDA.
Tobacco companies have produced a vulnerable population, thousands of millions of people, which to drug companies equates to thousands of millions of dollars, a marketing dream. but in this case dreams turned into a nightmare.
Preemption-it works both ways.
Brian
It’s probably time to consider all smokers as mentally ill. I believe chantix has forced smokers to face what hold nicotine has on their lives. The key attribute is the antagonist profile which blocks nicotines’s effect and subjects the smoker to some degree of withdrawal. Like all medications there is a treatment resistant population. They always seem to speak the loudest but their opinion should be weighed with the drugs larger benefit. Chantix was not marketed for the first year it was available but most reports AE came during the second year after the highly questionable Texas musician case. To me there is a certain level of deceit among the public which is considered ethical when it comes to pharma companies but in truth it debases us all..
Lisa Van S
Brian,
Is their any group of Individuals you dont consider Mentally Ill.
Brian
Lisa,
I’m okay..you’re ok but smokers are addicts in the exact same way as heroin, meth and cocaine abusers. Many would consider the latter as mentally ill with the same dopamine over stimulation fully prevalent in nicotine addiction. Post-mortem exam of a smoker shows increased level of nicotinic acetylcholine receptors over normal’s. I would say it’s definitely a sign of mental illness to be in need of a foreign substance to feel normal. I realize this may be considered a nouveaux interpretation of mental illness but it’s time has come.
Pat
MY daughter went off Chantix on Thursday and by Saturday experienced depression, an anxiety and now its been 4 weeks and she cannot teach or be left alone. Pfizer denies and such sides effects after taking chantix when I called them. but this is a solid 4th grade teacher who never had any mental problems
Lisa Van S
Pat,
The best advice I can give you is to, monitor her 24/7 until it passes, no one knows how long it will take, individual cases have varied. Unfortunately you wont recve any compassionate support here!… You can find withdrawal support on http://www.paxilprogress.org great support, from a great group of folks. Good Luck
henry
Chantix, our prescription treatment to aid smoking cessation achieved revenues of $280 million, an increase of 311% compared with the year ago quarter.
The DTC adverts work.
Cyndei
I was prescribed Chantix. Right after filling the prescription I learned of the possible side effects, causing anxiety and/of depression. I just happen to be a Zoloft patient too. Now I just want my money back from someone. My pharmacy says contact Pfizer, and Pfizer says contact my pharmacy. Kinda getting the run around, but patient enough to find out how I can get my out of pocket money I spent back. My prescription insurance too should get their part back too. Any advice?
pg
PFIZER CHANTIX
http://wwww.pharmalot.com/2008/01/pfizer-strengthens-suicide-warning-on-chantix-label/#respond
If I were a Pfizer agent I would be thanking some of you for falling for our ‘ tactics’ and so believing we are beginning to act honorably.
As I am NOT a Pfizer agent, I would like to remind you that Pfizer are NOT honorable and, for those of you who think they have suddenly and miraculously reformed their history of misconduct and lack of integrity in their scientific studies, would also like to draw your attention to the fact that in AT LEAST OCTOBER **2006** (and perhaps far earlier) Pfizer ALREADY knew that Chantix / Champix caused suicidal ideation, aggression, agitation, mood swings…etc….but didn’t get around to update the label until JANUARY 2008
Pfizer, as usual, waited to be caught out at what their drugs do before acting honorably (!). Had Pfizer actually BEEN honorable, then various Chantix / Champix suicides, and homicides such as that committed by Albrecht, would have been avoided. Had Albrecht been just an ordinary next door neighbour rather than a musician who had brought national attention to the matter, then there would still be no label update. Rather unlucky for Pfizer that it DID get brought to national attention because, while its really nothing but another psychiatric medication, nothing much different chemically than the usual unscientifically designed antidepressant or antipsychotic , it can’t so easily be blamed on the PATIENT as its not being promoted for ‘mental illness’.
People congratulating drug companies like Pfizer for honorable acts where there are none, are exactly what drug makers rely on and a big part of how they get away with it.
But MORE importantly, people who are seen to be trying to bring accountablility to the drug companies for the damage done by some of their drugs but who fail to research on others and end up endorsing the drug company as evidenced above when those drugs have been marketed and have caused deaths due to lack of honor on the part of the drug company involved…..are an even bigger asset to the drug companies, so please people, remember that and RESEARCH the facts on the drug you’re referring to before congratulating a drug company on its honorability. It can make things FAR worse if you don’t.
HERE is how I know PFIZER knew AT LEAST 15 months ago, and maybe even earlier:
http://www.network54.com/Forum/182310/message/1159916766/
“OCT 2006: ALERT TO SMOKERS. NEW ANTISMOKING DRUG IS **UNSAFE**
Posted October 4 2006 at 4:18PM admin…”
“….PSYCHIATRIC DISORDERS. Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. Infrequent: Aggression, Agitation, Disorientation, Dissociation, Libido decreased, Mood swings, Thinking abnormal. Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation…”
Thank you Pfizer, you pushed your drug Chantix to the US, then as Champix to Europe and have caused suicides and homicides and of course ‘mental illness’ in people simply wanting to give up smoking who have been misinformed by industry influenced drug regulators etc. Now, as usual, having got it established on the market by keeping quiet, you simply do what you did with Zoloft (keeping things hidden for as long as you could get away with it, quite some time with Zoloft, huh? 1983) see page 2 of 2 here:
http://www.ssri-uksupport.com/PfizerZoloft1983.pdf
just as your competitors do with Paxil, Prozac, Efexor, etc, - you just add the odd VERY LATE LABEL when you’re caught out, and keep raking the $$$ in for years while people die, by paying out whoever in fines and/or bribes to ensure that the drugs will stay on the market no matter how many people die. Because you, like your equally unethical competitors, KNOW that once you’ve got it past the drug regulators (in whichever way you find works with whichever member you’re dealing with!) and onto the market it’ll make you money for years.
PFIZER, HONORABLE?
It would be a complete change about and would save many thousands of lives if they were.
But VERY sadly, they remain anything BUT honorable.
pg
Justice in Michigan, you were right FIRST time. Any negotiation that is what we would see as ’successful’, on things a drug maker knew long before is because it is necessary FOR THE DRUG MAKE looking at long term profits to keep a dangerous drug on the market. It’s certainly not due to transparency, they already KNEW that DIRECT EFFECTS OF CHANTIX (not of the person taking it) were as listed in the post above. Pfizer knew that at LEAST in October 2006, and maybye far earlier, the date I give is that date I know of.
Transparency where life endangering effects are concerned would include immediately pointing those effects out, immediate and VOLUNTARY warning, etc.
You were right in your FIRST comment.
pg
The link above,
http://www.network54.com/Forum/182310/message/1159916766
refers to
http://www.rxlist.com/cgi/generic4/chantix_ad.htm
which states:
“…Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening…”
Whenever those clinical trial were undertaken, that was the date (which has to be before October 2006 when the network54 site reported) when Pfizer KNEW that these events happened.
It also includes the usual adverse PHYSICAL events that could not possibly have ANYTHING to do with ‘mental illness’ and in any event does anyone know of ANYONE in amongst the millions of people who have given up smoking either with no help, or with patches or gum, who have gotten the side effects listed for CHANTIX?
It IS the DRUG. It is not the smoker, or some underlying “hidden” illness. It happens when people start on CHANTIX, not before, not after and does not happen on millions of smokers giving up in any other way.
PFIZER’s CHANTIX or CHAMPIX is just another DANGEROUS DRUG very much like Zoloft - but marketed to get a different section of society to make a profit.
Kaylynn
I had serious rage issues and VERY serious hallucinations while taking it. On the 15 day I woke up on my balcony at 2 a.m. My first thought was “what am I doing out here?” my second was “Oh yes, I was going to go flying over the river because it’s such a nice mild evening”. My third as I put my foot on the railing was a terrified “I am not a bird! I can’t fly!!!”
Thank the stars I woke up. I “knew” I could fly –until I woke up.
I stopped taking them immediately. A report was filed with my physician and with the pharmacy and Pfizer. I have a lovely letter from the company stating that “Pfizer has never claimed that it’s medications are risk free.”
Weird dreams and emotions people can deal with as a risk of a medication. Hallucinations and violence are not acceptable.
This drug should be pulled immediately.
Ministry of Truth » Blog Archive » If suicide is painless does that make the Indy spineless?
[...] following a number of cases in the US that have linked the drug not only to suicide but in one case to a high profile shooting: A notable example, however, that drew national attention to Chantix was the case of Carter [...]
michelle m
my husband has taken chantix to stop smoking but for the 6 months he has been a complete pyshco, he has rage to the point he has become abusive physical and verbally, he has threatened to shoot me and my family, he has destroyed my dresser with his bare hands, he has punched holes in our home, he has come at me with garden shears, disconnected my car battery so i can not escape, and turned our home upside down in a fit of rage, the list could keep going. I had finally had enough and called the police, as a result he was arrested and went to jail for domestic violence. I dont believe we would be in this situation if he hadn’t taken the “CHANTIX” medication. He is now facing felony charges for domestic violence and is being treated by our family doctor with medication to balance him and is being treated by a counselor. Mine and my 2 childrens world has been turned upside down as a result of this drug, my 9yr old daughter has told her grandma she has been through so much over all of this, she is emotionally a reck, as for my 4yr old i can tell she has been affected, she hides when things get crazy and has told her grandpa mommy and her have a safe hiding place. No child should have to live like this. “CHANTIX NEEDS TO BE PULLED FROM THE MARKET” NOTHING GOOD CAN COME OF THIS!!!