Study Counters Warnings on Quit-Smoking Drug

Oct 3, 2009 | Posted by: roboblogger | Full story: Mental Help Net

The smoking cessation drug varenicline does not increase the risk for self-harm or depression, according to a new British study.

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“Just Say No to Smoking Bans”

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Oct 3, 2009
 

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Tell that to the families of the dead who took Chantix and then killed themselves. Absolutely F'n amazing the spin these people will put on these issues. Swallow a bottle of the pills yourself and see what happens, a holes.

“Just Say No to Smoking Bans”

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"the limited power of the study means we cannot rule out either a halving or a twofold increased risk"

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Oct 4, 2009
 

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Sheri wrote:
"the limited power of the study means we cannot rule out either a halving or a twofold increased risk"
Antis are good at talking out of both sides of their mouth with their forked tongues.

“KISS THIS SMOKERS BUTT”

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Oct 4, 2009
 

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Sheri wrote:
Tell that to the families of the dead who took Chantix and then killed themselves. Absolutely F'n amazing the spin these people will put on these issues. Swallow a bottle of the pills yourself and see what happens, a holes.
Wasn't there a man in Texas who took chantix , went next door and killed his neighbor?

“Just Say No to Smoking Bans”

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Oct 4, 2009
 

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u cannot own me wrote:
<quoted text> Wasn't there a man in Texas who took chantix , went next door and killed his neighbor?
I find it interesting that this "two-fold risk increase" is not a concern where it applies to Pfizer, yet there is an outrage over electronic cigarettes and shs. What is the risk increase of shs anyway? I know that as of now there is no risk increase for e cigs, yet Pfizer wants them banned. Why is that?

“Just Say No to Smoking Bans”

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Oct 4, 2009
 

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u cannot own me wrote:
<quoted text> Wasn't there a man in Texas who took chantix , went next door and killed his neighbor?
Yes, I believe there was. His family is suing Pfizer...hope they win.
mazed

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Oct 4, 2009
 

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Let's see, the authors of the study said their data failed to find a connection--not that there was no connection. Further, they cautioned that their study should NOT be regarded as conclusive and that further research was warranted.

Okay, so the media is trying to make these people's work into something that it wasn't. So are the people posting here.

Again, the "two-fold increase" was part of a comment that equally suggested a "halving". By Sheri's logic the reduction of the ill effects by half should be a cause for concern where Pfizer is concerned.

The entire sense of the sentence was that the study, while it failed to find a correlation, was not sufficient to rule out such a correlation, positive or negative.

Your twisting and removal of context for the sake of hysteria-mongering is pretty pathetic.
Time to quit

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Oct 4, 2009
 

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mazed wrote:
Let's see, the authors of the study said their data failed to find a connection--not that there was no connection. Further, they cautioned that their study should NOT be regarded as conclusive and that further research was warranted.
Okay, so the media is trying to make these people's work into something that it wasn't. So are the people posting here.
Again, the "two-fold increase" was part of a comment that equally suggested a "halving". By Sheri's logic the reduction of the ill effects by half should be a cause for concern where Pfizer is concerned.
The entire sense of the sentence was that the study, while it failed to find a correlation, was not sufficient to rule out such a correlation, positive or negative.
Your twisting and removal of context for the sake of hysteria-mongering is pretty pathetic.
Sheri has no logic. The person that they are referring to drank to excess. His blood alcohol level was more than twice the legal limit for driving in TX. He beat his girlfriend. She locked him out of the apartment. He began beating on his neighbors door and his neighbor shot him. Alcohol consumption definitely played a role in his death. It is unlikely that he would have hit his girlfriend and beat on his neighbors door if he had not been drinking. I quit smoking a number of years ago. I had vivid dreams when I quit. I was emotionally unstable when I quit. I went into a depression. I no longer had nicotine coursing through my veins. I was in physical and mental withdrawal. Chantix has helped lots of people quit. Some people are unable to quit, even with Chantix and that just shows the strength of the addiction. If these smokers were all that concerned about getting a dangerous drug off the market, they would be lobbying full time to get nicotine off the market. Smoking causes cancer, heart disease, lung disease, strokes, diabetes and shortens the lifespan of virtually anyone who does it. The proof is significantly better than the proof that Chantix is harmful, but these fools get upset every time something comes on the market to help people quit. None of these fools even understands about quitting because they have not done it yet, so they are the last ones that we should be listening to when it comes time to quit. They are afraid that they will end up in an even smaller minority of smokers and have even less political clout than they have today. They are sour grapes types of people because they are unable to quit they want everybody else to be unable to quit too.

“Just Say No to Smoking Bans”

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Time to quit wrote:
<quoted text>
Sheri has no logic. The person that they are referring to drank to excess. His blood alcohol level was more than twice the legal limit for driving in TX. He beat his girlfriend. She locked him out of the apartment. He began beating on his neighbors door and his neighbor shot him. Alcohol consumption definitely played a role in his death. It is unlikely that he would have hit his girlfriend and beat on his neighbors door if he had not been drinking. I quit smoking a number of years ago. I had vivid dreams when I quit. I was emotionally unstable when I quit. I went into a depression. I no longer had nicotine coursing through my veins. I was in physical and mental withdrawal. Chantix has helped lots of people quit. Some people are unable to quit, even with Chantix and that just shows the strength of the addiction. If these smokers were all that concerned about getting a dangerous drug off the market, they would be lobbying full time to get nicotine off the market. Smoking causes cancer, heart disease, lung disease, strokes, diabetes and shortens the lifespan of virtually anyone who does it. The proof is significantly better than the proof that Chantix is harmful, but these fools get upset every time something comes on the market to help people quit. None of these fools even understands about quitting because they have not done it yet, so they are the last ones that we should be listening to when it comes time to quit. They are afraid that they will end up in an even smaller minority of smokers and have even less political clout than they have today. They are sour grapes types of people because they are unable to quit they want everybody else to be unable to quit too.
Had there been just that one suicide, then your point would be valid. The musician from Dallas has become the poster child for Chantix suicides much as Heather Crow is the poster child for shs.
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.
http://www.pharmalot.com/2008/07/widow-sues-p...

“Just Say No to Smoking Bans”

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Oct 4, 2009
 

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mazed wrote:
Let's see, the authors of the study said their data failed to find a connection--not that there was no connection. Further, they cautioned that their study should NOT be regarded as conclusive and that further research was warranted.
Okay, so the media is trying to make these people's work into something that it wasn't. So are the people posting here.
Again, the "two-fold increase" was part of a comment that equally suggested a "halving". By Sheri's logic the reduction of the ill effects by half should be a cause for concern where Pfizer is concerned.
The entire sense of the sentence was that the study, while it failed to find a correlation, was not sufficient to rule out such a correlation, positive or negative.
Your twisting and removal of context for the sake of hysteria-mongering is pretty pathetic.
Other than spin control for Pfizer then, what is the point of this press release?

“Just Say No to Smoking Bans”

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In the 4th quarter of 2007 varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury for 769 different drugs in the 4th quarter. Only 35 drugs accounted for 100 or more reports. This large volume of reports prompted us to conduct an analysis of all adverse events for varenicline since marketing approval in 2006.
The FDA has recently issued a Public Health Advisory about one of the most marked adverse effects of varenicline, psychiatric symptoms that included “changes in behavior, agitation, suicidal ideation, attempted and completed suicide.” 2 However, the FDA alert provided no information about the numbers of reported neuropsychiatric events among treated smokers.
From May 2006 through December 2007, the FDA had received 227 domestic reports of suicidal acts, thoughts or behaviors, 397 cases of possible psychosis and 525 reports of hostility or aggression. These totals included 28 cases of suicide and 41 mentions of homicidal ideation, 60 cases of paranoia and 55 cases of hallucination. The categories were not mutually exclusive.
However, the adverse drug event reports for varenicline describe other kinds of serious harm for which no warnings now exist, either from the FDA or from the manufacturer, Pfizer Inc. The cases (including those with psychiatric effects) were classified using standardized medical queries developed by the pharmaceutical industry to identify potential adverse events in clinical studies and postmarket surveillance. Adverse event reports in themselves do not establish a causal link to the drug, only that an observer suspected a relationship. Depending on the features of the specific event, it could be counted in multiple categories, and classifications are not definitive. Among the most prominent were:
· Accidents and injuries. A total of 173 serious events described accidental injury, including 28 road traffic accidents and 77 falls, some leading to fractures of rib, facial bones, hand, ankle, spine, and lower limbs. In these cases a variety of potential causes were identified, including loss of consciousness, mental confusion, dizziness and muscle spasms.
· Vision disturbance. At least 148 reports contained medical terms indicating vision disturbances, including 68 cases described as blurred vision and 26 terms indicating transient or other forms of blindness. This reported effect could also describe a mechanism that could or did contribute to accidents and injuries.

“Just Say No to Smoking Bans”

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· Heart rhythm disturbances. The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have non-cardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms
· Seizures and abnormal muscle spasms or movements. Serious reported events included 86 cases of convulsions (seizures), 372 reports of a wide variety of movement disorders, including tremors, muscle spasms, twitching, tics, drooling, and motor hyperactivity. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from these data.
· Moderate and severe skin reactions. Reported serious events included 338 cases of hives or swelling of the tongue, face, eyes, lips or other areas. In addition, 65 cases were classified as severe and included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.
· Diabetes. The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified numerous cases of symptoms and laboratory tests consistent with new onset diabetes.
http://www.ismp.org/docs/vareniclinestudy.as · Accidents and injuries. A total of 173 serious events described accidental injury, including 28 road traffic accidents and 77 falls, some leading to fractures of rib, facial bones, hand, ankle, spine, and lower limbs. In these cases a variety of potential causes were identified, including loss of consciousness, mental confusion, dizziness and muscle spasms.
· Vision disturbance. At least 148 reports contained medical terms indicating vision disturbances, including 68 cases described as blurred vision and 26 terms indicating transient or other forms of blindness. This reported effect could also describe a mechanism that could or did contribute to accidents and injuries.
· Heart rhythm disturbances. The FDA received 224 domestic reports classified as potential cardiac rhythm disturbances. This category, however, was dominated by reports of sudden loss of consciousness, an event that could also have non-cardiac causes. However, this category also included smaller numbers of cardiac arrests and identifiable abnormal cardiac rhythms
· Seizures and abnormal muscle spasms or movements. Serious reported events included 86 cases of convulsions (seizures), 372 reports of a wide variety of movement disorders, including tremors, muscle spasms, twitching, tics, drooling, and motor hyperactivity. The extent to which these problems resolved with a reduced dose or by halting treatment could not be determined from these data.
· Moderate and severe skin reactions. Reported serious events included 338 cases of hives or swelling of the tongue, face, eyes, lips or other areas. In addition, 65 cases were classified as severe and included blisters, exfoliation of the skin and lips, and Stevens-Johnson Syndrome.
· Diabetes. The FDA has received 544 reports suggesting varenicline may be related to a loss of glycemic control. This category included many cases of weight loss or gain that could have alternative causes, but also identified numerous cases of symptoms and laboratory tests consistent with new onset diabetes.
http://www.ismp.org/docs/vareniclinestudy.asp

“Just Say No to Smoking Bans”

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Recommendations

We have immediate safety concerns about the use of varenicline among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury. Other examples include persons operating nuclear power reactors, high-rise construction cranes or life-sustaining medical devices. Based on reports of sudden loss of consciousness, seizures, muscle spasms, vision disturbances, hallucinations, paranoia and psychosis, we believe varenicline may not be safe to use in these settings. The extent to which varenicline has already contributed to accidental death and injury has not yet been investigated because these adverse effects had not been previously reported. The Federal Aviation Administration approved varenicline for use by airline pilots3 before most of these reports were available.



In addition, we recommend that patients and doctors exercise caution in the use of varenicline and consider the use of alternative approaches to smoking cessation.



Finally, we urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks. We promptly notified the FDA of our findings.







This report was written by:



Thomas J. Moore, Senior Scientist, Drug Safety and Policy, ISMP

Michael R. Cohen RPh, MS, ScD, President, ISMP

Curt D. Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine.



Sez Who

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Oct 4, 2009
 

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Sheri wrote:
<quoted text>
Other than spin control for Pfizer then, what is the point of this press release?
To describe the findings of a controlled study of 80,660 men and women, which found no evidence that Chantrix increases the risk for self-harm or depression. This is of interest to many people who are trying to quit smoking and many be considering using Chantrix, who are trying to weigh the benefits and dangers.

You seem to be a fear monger for the dangers of anything that may assist people to successfully quit smoking. Why? Since you have not tried to quit yourself, you have no personal stake in this discussion.
Sez Who

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Sheri wrote:
Recommendations

Finally, we urge the FDA and the manufacturer to provide warnings to doctors and patients for those adverse effects that can be adequately documented through existing data, and to undertake on a priority basis epidemiological studies or other research to assess other potential risks.
Since you posted the whole thing, you must approve of the contents. Do you approve of the section that recommends "...undertake on a priority basis epidemiological studies or other research to assess other potential risks" ? Do you understand that the British study you are maligning is responsive to that recommendation?

“Just Say No to Smoking Bans”

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Sez Who wrote:
<quoted text>
To describe the findings of a controlled study of 80,660 men and women, which found no evidence that Chantrix increases the risk for self-harm or depression. This is of interest to many people who are trying to quit smoking and many be considering using Chantrix, who are trying to weigh the benefits and dangers.
You seem to be a fear monger for the dangers of anything that may assist people to successfully quit smoking. Why? Since you have not tried to quit yourself, you have no personal stake in this discussion.
Ahh, but I do have a stake in warning people about any kind of drug that alters the brain since I had that experience with anti-depressants. They are horrible drugs that should be used only in a state of emergency. I intend to continue this warning WITHOUT your permission.

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Sez Who wrote:
<quoted text>
Since you posted the whole thing, you must approve of the contents. Do you approve of the section that recommends "...undertake on a priority basis epidemiological studies or other research to assess other potential risks" ? Do you understand that the British study you are maligning is responsive to that recommendation?
Here's what jumped out at me.
In the 4th quarter of 2007 varenicline accounted for 988 serious injuries in the U.S. reported to the FDA, more than any other individual drug in this time period. By comparison the FDA received a median of 5 reports of serious injury for 769 different drugs in the 4th quarter. Only 35 drugs accounted for 100 or more reports.
Sez Who

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Sheri wrote:
<quoted text>
Here's what jumped out at me.
In the 4th quarter of 2007 varenicline accounted for 988 serious injuries...
Did you know there is a nonprescription drug that kills 400,000 Americans a year?

http://www.americanheart.org/presenter.jhtml...

I await your outrage.
mazed

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Oct 5, 2009
 

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Sheri wrote:
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Other than spin control for Pfizer then, what is the point of this press release?
Are you saying studies that do NOT support the correlation must be regarded as simply spinning press releases and need justification beyond their existence in order for the public to see them?

Well, of course, you would be. Why am I surprised?
mazed

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Sheri wrote:
<quoted text>“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.
Ah, yes, and quoting the attorney of the woman suing the company added such a nice touch to the credibility of your post. Always best to have the opinion of an unbiased expert in the field when examining scientific evidence.

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