Chantix Tops New Report On Serious Side Effects
18 CommentsBy Ed Silverman // October 22nd, 2008 // 2:21 pm
The number of serious problems and deaths linked to medications reported to the FDA set a record in the first three months of this year, the Institute for Safe Medication Practices reports. The FDA received nearly 21,000 reports of serious drug reactions, including over 4,800 deaths, according to ISMP’s an analysis of federal data dating to 2004. Yearly totals went back to the 1990s.
Two drugs accounted for a disproportionately large share of the latest reports. One was heparin, the tainted blood thinner from China that caused an international safety scandal. The other was Chantix, a new kind of anti-smoking drug from Pfizer, which refuted the findings. The drug accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1001 new cases, including 50 additional deaths. Earlier this year, the FDA warned that Chantix may be linked to psychiatric problems, including suicidal behavior and vivid dreams, and the government banned it for pilots.
In a statement, the FDA tells The Wall Street Journal that it “confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline (Chantix) in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate.”
“We believe that one of the most important tools to promote is to monitor trends on a regular basis,” Thomas Moore, a senior scientist with ISMP, tells the Associated Press. “Knowing which drugs are causing injuries and how many people are being hurt is the raw material we need to fashion sound measures to promote patient safety.”
The total of 20,745 cases reported from January to March was 38 percent higher than the average for the previous four calendar quarters, and the highest for any quarter, the report said. Fatalities accounted for 23 percent of the cases. The total number of deaths, 4,824, was an increase of nearly 3 percent from the last calendar quarter of 2007 (here is the report).
Previous research from ISMP has shown that serious drug safety problems reported to the FDA increased markedly from 1998 to 2005. The FDA case reports provide a signal of possible problems with a drug, but a cause-and-effect connection can only be established through painstaking investigation.
Source: Associated Press
James R
Pfizer needs to say that Chantix, when used as directed, could have a devestating effect on public safety if a pilot blacks out.
That’s the thing about Chantix, you really have no idea if it is toxic to your body. You really have to hope that it is not.
Instead, they have a press release that tries to blame patients that have contacted the FDA with firsthand reports about issues with Chantix.
Sam
The FDA needs to take a stand against an anti-smoking drug that has caused over 1000 adverse effects and probably more incidents never reported, and forget about corporate profits and label changes and more about patient safety. Take the drug off the market.
John Q
Not only should the FDA be charged with these deaths and injuries, but also Pfizer and their whole host of “experts” that have lied and continued to push this deadly drug to the consumers.
It is a outrage and should be punished with the same “biased” judgement as the team of experts paid by Pfizer. Pfizer is paying “experts” to kill and injure innocent people that have relied on this information to be true and factual.
How long will the consumer suffer from the lies told by the FDA, Pfizer and their “experts” before one of them has the decency to come forward and tell the truth.
It will be amazing to actually see someone do as they are paid to do. Or, is that the proposal we are seeing now?
Jim
John Q
Right now the consumers are speaking with their pocket books; Chantix sales are continuing to decline.
I believe this could be the confluence of two events, the consumers awareness of the negative effects and possibly doctors reluctance to prescribe the drug.
I for one believe the Chantix problems thus far reported are merely the tip of the iceberg and the chantix wonder drug will soon fade into fen-fen obscurity.
On another note, Pfizer reinstituted its advertising progam but I must admit I have seen less and less of these commercials on TV. However, I just may be watching the wrong programs.
Jaynesday
Jim, Your comment about the consumer speaking with their pocket book is the crux of what I feel is the only way to turn around pharma. The current course is unacceptable.
If the consumer’s power to correct bad products is taken away with preemption,
If the FDA continues to turn a deaf ear to the consumer and side with the manufacturer,
If Pharma will continue to advertise poor product directly to the consumer,
Then a networked system of product warnings (grading of products) must be established to help the consumer steer clear of bad product.
An early warning system must be establish for self protection of the consumer in lieu of the currently failing system.
Consumers must be empowered to “speak” to the manufacturer in the only language they will listen to, that being their pocket book.
Justice in MI
Hi Jaynesday - I’m trying to get a clearer idea how this would happen. how would consumers get the info they needed to make choices? Do you imagine a data base independent of FDA? (There are some.) Reliance on groups like Health Reserach Group/Public Citizen?
As has been noted, there are a few drug safety systems independent of FDA. (And, yes, FDA is “second-guessed” by these every day, so another pro-preemption argument goes up in smoke.)
These include organizations like BC’s Therapeutic’s Initiative, Medicaid systems in some states (which stopped buying Vioxx two years before it was withdrawn, and on a safety, not cost, basis), HRG of Public Citizen (which directly warns people against using certain meds), counter-detailing programs, the Medical letter to a degree, and elsewhere. As you may know, one of the consequences of PDUFDA was that some of FDA’s own drug safety initiatives had to be cut back in order to meet their share of PDUFA obligations. This has nothing to do with “coziness” - just resource allocation.
Do you imagine consumers making use of such resources? Do they need to be organized in some way - a kind of patients’ union - sas opposed to each acting individually with their particular docs?
Jaynesday
Justice,
It needs a name - Pharmaceuticals Monitoring and Feedback Organization maybe. (PMFO)
I could only suggest crazy ideas being an outsider but yes unattached to FDA would seem wise now. However if major organizational changes could happen, namely a fresh start with disconnection to political and pharmaceutical relationships along with a total revamp of the AE system, then maybe FDA affiliation wouldn’t be a problem. I would think that a total deconstruction and rebuild would be required.
The other option as you mentioned would be to increase the scope of current monitoring groups. Public funding, establishing requirements for nationwide reporting and feedback methods through a nationwide network, etc are some of the things that would be needed. Among others of course.
What I would see it boiling down to would be that every drug and device would have a simple to understand rating or ranking evaluation (possibly every drug/device manufacturer itself should also be rated). When a doctor says to a patient “we need to put you on this drug” he will have at his disposal, and will be expected to provide, the current (real time) evaluation of that product to the patient so that together they can review options and make decisions together.
So you might hear this - Well Bob, we need to take care of your pain. Here are our options. Drug A is rated at a 5 out of 10 the manufacturer is rated overall as a 2. Current problems with this drug are xxxxx and you need to watch out for yyyyy. Drug B is rated at a 8 of 10 and the manufacturer. is rated at a 9. The cost of drug A is $50 per and Drug B is $70 per. What do you think. Are you willing to pay the extra price or not?
So this establishes the typical free market system again in the drug/device market place. No two ways around it the manufacturer is dealing directly with the customer and as we know the customer is always right.
John Q
Chantix is second compared to a tainted drug from China. Where is the outrage? Have we become so accustomed to lies and false reports that this is acceptable?
Who is accountable for the continuation of falsehoods? Pfizer and their experts. What involvement does the FDA maintain with this revolting company to allow such travesty?
The worlds largest smoking cessation experts and clinics are involved with refusals to admit and hard denials to the AEs reported. Millions are being poured into education partners by Pfizer while patients suffer and die.
Surly answers and justice will come. Until that day, patients and doctors alike will look to the FDA for drug safety and information. Sad.
Justice in MI
Thanks, Jaynesday. Essentially, you are suggesting an evidence-based system as many have put forward.
As is clear, making such asessments would require reliable data, which is probably the biggest hindrance of all. We did not learn much about Vioxx and Celebrex, for example, until FOIA requests forced the raw data out of FDA.
Certainly, there are other surveillance organizations, and some do head-to-head studies of safety and efficacy. For obvious reasons, such comparative studies are rarely pursued by the industry.
Some states have, in essence, created their own systems via Medicaid formularies (which, by law, have to be based on efficacy/saftey, not cost). Of course, the very existence of such systems flies in the face of the notion that FDA must be the sole arbitrer of such things - it never has been and, until the current administration, virtually never claimed to be.
Whatever the alternate systems are, the current FDA is clearly is not it. In the absence of new institutions, smart consumers and physicians will need to go a good deal of work on their own to make reliable judgments.
Needless to say, with preemption, the urgency to do so will increase many-fold for those not wanting to play Russian roulette with their healthcare.
Pharmacritique
Justice in MI
Well, independant drug evaluation systems are in bade shape nowadays… Just look what happens to therapeutics Initiative in BC…
Merrill Goozner from the Center for Science in the Public Interest tells us in an article we can support Therapeutics Initiative by sending a letter or a mail to the chairman of the review committee.
http://www.gooznews.com/archives/001217.html
“A source tells us the provincial government recently announced that a review of the Therapeutics Initiative would be conducted at the University of British Columbia October 30 and 31, 2008. Bassam Masri, chairman of the Department of Orthopedics at UBC, will serve as chair of the review committee and the external reviewers will be David Henry, President and CEO of the Institute for Clinical Evaluative Sciences, Lisa Dolovich of the Centre for Evaluation of Medicines at St. Joseph’s Healthcare Hamilton, and Jean Gray of the Department of Pharmacology at Dalhousie University.Our sources in the international medical community tell us that a letter of support for continued funding for TI is being circulated and will be sent to Dr. Masri. Supporters of TI can write Dr. Masri at the following address:
Bassam A. Masri, M.D.
Gordon & Leslie Diamond Health Care Centre
3rd Floor, 2775 Laurel Street
Vancouver, BC V5Z 1M9
Canada
bas.masri@vch.ca
*
I wrote about this on Pharmacritique and gave some other links.
http://pharmacritique.20minutes-blogs.fr/archive/2008/10/15/big-pharma-veut-eliminer-therapeutics-initiative-groupe-cana.html
John Q
Why has it taken so long with much pleading from patients for this information to become available, if only to stop others from the same fate? One of the majors problems with patients reporting the AEs to their doctors has been Pfizer is a well oiled machine with all their lies and insist that patients are only experiencing nicotine withdrawal. Patients are still getting prescriptions of Chantix from their doctors because patient rely on the doctor to be concerned about their health, not pharma.
Does nicotine withdrawal cause these AEs? According to Pfizer and their team of experts that is the only problem. So many doctors have been willing to stand behind Pfizer’s bullying and their lies even as patients are experiencing the horrible side effects and death. Why are the doctors so willing to believe pharma over the patients? How has this medication become second in AEs only to tainted heparin from China?
Before the system can move forward some hard questions must first be answered. While there are varied ideas about the future, what is happening now and why? Lives depend on some answers.
Justice in MI
Pharmacritique - Thanks for your important update. TI has been essential for many of us.
John Q. - I don’t know anything about Chantix per se (beyond what I’ve read on Pharmalot). But is it sad, indeed, that patients have to become researchers within the current environment.
Unfortunately, I believe that is what they have to do.
Justice in MI
the leter below sent:
Dear Dr. Masri:
I was shocked to learn that Therapeutics Initiative is facing the possibility of
discontinuation. I personally rely on TI, and I use it as an example of evidence-based
medicine in my courses at the University of Michigan.
If it is discontinued, I will continue to use it as an example - not only of EBM, but of
what happens to EBM within the current climate. Indeed, exploring TI’s fate, the reasons
for it, and the individuals and interests involved, will itself become a research project
in my course.
Regards,
James R
We could talk all day about AE’s and their innacurate assertions about Chantix. Pfizer does seems confused to how they should handle this time-bomb.
With that said, Chantix is a whole different animal. It seems that this drug deeply affects many patients, making basic thinking processes diffucult or sometimes impossible.
More testing and trials are definitely appropiate with this drug. Until that time, reports of severe psychotic side effects will continue to rise.
Apparently, Pfizer has chosen to blame patients who have reported their experiences to the FDA via the MedWatch reporting system. They also claim that nicotine withdrawal is a resonable explanation as to why patients have had phychotic episodes. I find that hard to believe. Maybe Pfizer should concentrate on how this medicine causes changes in the brain’s normal functions, including how long it may take for patients to start feeling normal again, if ever
John Q
My point is why and how is this happening? There are experts that are arguing the fact that any “real” side effects are not happening while patients are suffering and dying and at the same time the FDA refuses to handle this crises.
OK, try it like this. Put any name you want with Chantix. Call it any drug you can think of and then put that in the contents of Chantix and the reports from the ISMP(the FDA has confirmed the reports). It has caused many deaths and AEs quickly after its launch. Reports have only gotten worse and the FDA has turned a blind eye, and doctors do not want to talk about it as their “experts” have assured them it is not the drug causing these heart attacks, suffocation, psychiatric disorders etc.
How has this happened? How have we let pharma rule in this manner? If this is not handled in a manner that disallows pharma from paying for data, experts and even the FDA, the medical field will be playing “doctor” with the general population as the patient will know more about the true nature of the drug than the real doctors.
Jim
I have written this before but the reason that Chantix is allowed the leeway that it is granted is because of the anti-smoking crusaders inside and outside of government. I know this is not the only reason because Chantix is only marginally more effective then Bupropien over the course of 52 weeks and Bupropien (Zyban) no longer enjoys patent protection.
The new ads mention the psychiatric symptoms but they fail to disclose the more serious physical side effects that manufacturers of other drugs are required to disclose in their ads; other drugs mention the risk of lymphoma as a possible adverse event and I am sure that this side effect is listed as Rare in the Prescribing Information.
belinda smith
My doctor perscribed chantix to me october 2007 and I have not been the same person since. I have horrible dreams of dying and deamons trying to kill me. I am a truck driver and I am now 44years old, I am a mother of three children. My children help me with my buisness. There ages are 24,21 and 19, they wanted me to quit smoking so I asked my doctor for help and he perscribed chantix and since I have very bad mood swing out of know were my children are affaid of me. I have threatened to hurt them and hurt myself and I have also threatened to hurt my husband I cry all the time an I am always have suicidle thoughts and I always cry for know reason. I have lost two ontracts behind this problem. I need some help for myself and the safety of my family. I have a new grandbaby and love her and my family more than anything in this world. I did not realze that something was wrong with me until my sister told me that the medicine chantix that I took had bad effects and people jave died. need help because I cant stop crying, I cry day and night for no reason. I want my life back I feel like I am going to die
David Fry
See
http://www.cancer.org/docroot/PED/content/PED_10_2X_Cigarette_Smoking_and_Cancer.asp
and
http://www.naag.org/adoption-of-fire-safe-cigarettes-by-tobacco-industry-may-save-countless-lives.php
440,000 people a year die from smoking related diseases. 1000 a year die from smoking related fire deaths and tens of thousands are seriously maimed. The cost of smoking throughout a lifetime is in the tens of thousands of dollars.
The quality of life of a smoker is greatly diminished. Some of alternative treatments to CHANTIX probably should be tried first by most smokers but have a very low success rate.
CHANTIX has by far the best success rate. I smoked for 30, tried every method in the book to quit. Was starting to have some of the more serious smoking related health problems, and CHANTIX worked like a charm. For me it was a life saving miracle drug.
Most chemo therapies have serious side effects that make the side effects of CHANTIX look mild. Nobody in their right mind would be screaming about those side effects.
Smokers who want to quit should not have CHANTIX taken away as a means of quitting.
If even 1 tenth of the people who die or are injured each year of smoking caused fires alone are saved that fate the positive effects of CHANTIX would out weigh the negative effects.
The way these drugs should be evaluated is by making an honest weighing of the positive against the negative, not by a mindless focus on the negative alone. When I was prescribed the drug my doctor was very careful in making sure that I was aware that the drug had known side effects, and probably had some unknown side effects, but that the success rate was so high that I’d be crazy not to try it. This same doctor had refused to prescribe me ZYBAN several year prior to CHANTIX coming out, because he felt the side effects of ZYBAN were to severe to justify the possible benefits.
PLEASE, PLEASE, PLEASE!!!! TAKE A RATIONAL APPROACH TO EVALUATING CHANTIX