Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Chantix No Better Than Nicotine Patches Except When It Comes to Suicide Rates

Chantix No Better Than Nicotine Patches Except When It Comes to Suicide Rates | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In disappointing news for Pfizer, a study found that its controversial Chantix pill for quitting smoking failed to show any benefit over nicotine patches and lozenges among people trying to kick their habit.


Although the study did not question the effectiveness of the product, the findings may represent another hurdle in the quest to transform Chantix into a blockbuster seller. Ever since it was approved a decade ago, Chantix has been dogged by safety concerns, lawsuits, and languishing sales.


The study, which was published in the Journal of the American Medical Association, compared three approaches to quitting smoking in which 1,086 patients either used a nicotine patch, the Chantix pill, or a combination of a patch and nicotine lozenge.


The findings, which relied on lab tests to gauge carbon monoxide levels, did not find any statistically significant differences between the products at either six months or one year. At six months, for instance, the quit rate was 23 percent for the patch; 24 percent for Chantix; and 27 percent for a patch and lozenges. And at one year, the quit rate was 21 percent, 19 percent, and 20 percent, respectively.

Pharma Guy's insight:

I was wondering why I'm seeing more Chantix ads on TV after a lull. I guess Pfizer was trying to get as many new Rx's as possible before these data came out. For more information about Chantix and suicide, read "Consumer Groups Petition FDA to Keep Black Box Warning for Pfizer’s Chantix"; http://sco.lt/76uiDx 

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FDA Updates Chantix Label to Include Potential Alcohol Interaction

FDA Updates Chantix Label to Include Potential Alcohol Interaction | Pharmaguy's Insights Into Drug Industry News | Scoop.it

AUDIENCE: Family Practice, Patient, Pulmonology


ISSUE: FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. FDA has approved changes to the Chantix label to warn about these risks. Refer to the Drug Safety Communication for a detailed data summary.


BACKGROUND: Chantix is a prescription medicine that is FDA-approved to help adults quit smoking.


RECOMMENDATION:  Healthcare professionals should weigh the potential risk of seizures against the potential benefits before prescribing Chantix in patients with a history of seizures or other factors that can lower the seizure threshold. Advise patients to immediately stop taking Chantix if they develop agitation, hostility, aggressive behavior, depressed mood, or changes in behavior or thinking that are not typical for them, or if they develop suicidal ideation or behavior.

Until patients know how Chantix affects their ability to tolerate alcohol, they should decrease the amount of alcohol they drink. Patients who have a seizure while taking Chantix should stop the medicine and seek medical attention immediately.


Also refer to the Drug Safety Communication for more information for patients and healthcare professionals.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Pharma Guy's insight:


Meanwhile, it's long been reported that Chantix is "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch." Read more about that here.

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Consumer Groups Petition FDA to Keep Black Box Warning for Pfizer’s Chantix

Consumer Groups Petition FDA to Keep Black Box Warning for Pfizer’s Chantix | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Several consumer groups have petitioned the FDA to increase the warnings about the controversial Chantix smoking-cessation drug, which has been linked to risks of suicidal behavior and hostility, based on new scientific information they say has become available since a serious warning was placed on the product labeling five years ago.


In their petition, the groups cite fresh analyses of studies and side effect reports to argue the pill causes distinct psychiatric side effects – suicidal ideation and behavior, aggression and violence, psychosis, and depression – which should be more clearly spelled out in the product labeling.


The move comes one week before an agency advisory panel will review whether some of the existing warnings on the Chantix labeling should be removed, a step that Pfizer, which sells the drug, has requested based on the results of several studies. Last month, in fact, the FDA updated the labeling to indicate the drug may not carry the risks of suicidal behavior.


Pfizer maintains that change was warranted based on a meta-analysis of five studies involving nearly 2,000 patients that did not show an increase in suicidal thoughts or actions among those who took Chantix compared with a placebo. The drug maker also pointed to four observational studies of thousands of patients that did not find differences in risk between its pill and other nicotine treatments.


The petition, however, also argues that those recent studies had methodological flaws and other limitations. “None of the studies are of sufficient quality to establish a convincing estimate of incidence, provide a valid comparison to other treatments, or have the scientific weight to refute evidence from other scientific methods,” the groups wrote.

Pharma Guy's insight:


In a comment to this post a certain Dr. Epi wrote:


The comment by Pfizer is amusing to any scientist, unless the scientist is taking Chantix. None of the research that the company cites re Chantix is any better at proving causation (or lack of causation) than adverse reaction reports. All most of those studies can show is association, not causation. That’s why replication in science is so important — as is close examination of individual patients. Adverse event reports can tell you if the patient experienced the side effect after taking the drug and it went away when they stopped. The more dramatic the adverse reaction — and the Chantix reports are very dramatic — and the more they show a pattern (ditto re Chantix reports) the more likely they are to show causation.

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Pfizer Wants Black Box Removed From Chantix Label

Pfizer Wants Black Box Removed From Chantix Label | Pharmaguy's Insights Into Drug Industry News | Scoop.it
In a boost to Pfizer, the FDA has updated labeling on its Chantix smoking-cessation pill to indicate the drug may not carry the risks of suicidal behavior, a controversial issue that prompted the agency to include a serious warning in the labeling in 2009.


The labeling change, by the way, was made on September 19, but Pfizer had not publicly discussed the changes until today, when a watchdog group called the Institute for Safe Medicine Practices planned to release an analysis placing Chantix in an unflattering light and calling for the Black Box warning to be strengthened. The timing of the disclosure of the labeling change suggests that Pfizer sought to mitigate any negative publicity that may have ensued.


The labeling change also comes just three weeks before the FDA holds an October 16 meeting to discuss “safety data from observational studies and a meta-analysis,” according to a September 9 notice in the Federal Register. These are the same data that is now referenced in the updated Chantix labeling. So why have a meeting?


Pfizer would like the serious warning, which is known as a Black Box in regulatory parlance, removed, the Associated Press writes.


Meanwhile, ISMP reviewed side effect reports filed with FDA and found that Chantix accounted for more cases of suicide, self-injury or homicidal thoughts than any other therapeutic drug between 2007 and the third quarter of 2013. Moreover, Chantix ranked first in both suicidal and self-injurious thoughts as well as homicidal thoughts, and these reports outnumbered those for any other drug by more than three times.


Pharma Guy's insight:


Chantix may be "eight times more likely to be linked with a reported case of suicidal behavior or depression than other nicotine replacement products, such as the nicotine patch," as reported by authors of this study: "New study says Chantix raises suicide risks"

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NIH & Former Amarin Exec Push Drug Made from Bulgarian Trees to Compete with Chantix

NIH & Former Amarin Exec Push Drug Made from Bulgarian Trees to Compete with Chantix | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Rick Stewart didn’t know about the laburnum trees growing in Bulgaria — and their potential to produce a drug for quitting smoking — back when he was the chief executive of the pharmaceutical company Amarin.


He was too deep inside the drug industry, a place often criticized for its short-sighted focus on profits. He had to fail first. Only then could he spot the opportunity in those yellow-flowering trees.


Now, with the help of the National Institutes of Health, Stewart is trying to introduce the laburnum-derived drug to the U.S. market. The pill works by interrupting tobacco cravings, much like Pfizer’s top-selling Chantix, but possibly without that drug’s high-profile side effects and at a much lower price. A recent run of positive studies have buoyed the pill’s prospects. Today, researchers are excited about what could be the first new treatment for smoking cessation to emerge in years.

Pharma Guy's insight:


NOTE: In 2008, Chantix (sold as Champix overseas) posted $846 million in worldwide sales. But that blockbuster number dropped 17 percent the next year when the FDA slapped a “black box” warning on Chantix and Zyban because of the risk of suicidal behaviors and other mental-health problems. Facing a wave of damaging publicity, Pfizer went on to settle 2,900 lawsuits for nearly $300 million. Chantix’s reputation is still suffering. Last year, it recorded $647 million in sales.

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FDA says Pfizer's Chantix must continue to be Pilloried by 'black box' label

FDA says Pfizer's Chantix must continue to be Pilloried by 'black box' label | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Pfizer's controversial smoking-cessation drug Chantix will continue to be stuck with a black-box warning label at least until late next year, assuming the U.S. Food and Drug Administration follows the recommendations of its experts.


On Thursday, an advisory panel for the regulatory agency voted to hold fast on maintaining the FDA's most severe warning label on the product, which has been reported to trigger suicidal depression, intense anger and other psychiatric troubles. Those claims began to surface soon after Pfizer launched the stop-smoking drug in 2006.


The label and news reports quickly eroded Chantix sales, which have dipped by $648 million this year, slightly off from 2013--and significantly down from $846 million recorded in 2008. Plus there were the lawsuits. Last year, Pfizer paid out more than $275 million to settle thousands of them alleging that Chantix triggered suicides, suicidal thoughts and other psychiatric problems.

Pharma Guy's insight:


In the Larry Niven science fiction story, Death by Ecstasy, a belter, Owen Jennison, is found dead on Earth in a locked Los Angeles apartment. His death is an apparent suicide. Hamilton, a friend and former crewmate of Jennison, is called to the scene to investigate. He finds Owen with a droud (a wirehead's transformer) plugged into the back of his head. The latter apparently starved himself to death while continuously stimulating the pleasure center of his own brain.

In the real world of today, there are many legal and illegal drugs and other chemical compounds that people use to stimulate their pleasure centers. One such agent is nicotine. Another is Pfizer's Chantix, a smoking cessation drug that competes with nicotine to stimulate the brain's pleasure center. In other words, Chantix takes the place of nicotine and like nicotine stimulates dopamine production, which "gives you a feeling of pleasure."


Pfizer should take advantage of the vivid, Chantix-induced dreams/hallucinations reported by patients and redesign their ads with that in mind. Find out more about that here: Chantix Californication Dreamin'

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Pfizer settles all 2,900 lawsuits against its anti-smoking drug Chantix

Pfizer settles all 2,900 lawsuits against its anti-smoking drug Chantix | Pharmaguy's Insights Into Drug Industry News | Scoop.it
All of the nearly 2,900 lawsuits claiming pharmaceutical giant Pfizer Inc.'s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled - for about $300 million - so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday.


Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a less severe warning label for Chantix.


While the lawsuits are now in the rear view mirror for Pfizer, the company is fighting to get the U.S. Food and Drug Administration to ease up on the "black box" warning on Chantix - a label added in 2009 to warn of potential serious side effects.   


The Wall Street Journal recently reported that the FDA in September updated the warnings and precautions section on Chantix to include information about some new studies that show the drug's psychological effects, including suicide, isn't as bad as once thought.


Pharma Guy's insight:


Say Pfizer wins its case against the FDA and is no longer required to include black box warnings about "new" serious side effects. That would mean that Pfizer can more aggressively market Chantix, including "reminder" ads on Twitter. However, I am sure that Pfizer sales reps will NOT be distributing reprints focusing on the "new" safety information, the rules for such distribution were recently relaxed by the FDA (read "Presenting 'New Risk Information' About Drugs to HCPs").

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K.I.R.M. God is Business " From Day One"'s curator insight, July 2, 4:51 AM

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