As part of its service to drug consumers, the FDA has recently been providing a video service, or news show called FDA Patient Safety News. Billed as a video news show for health professionals, FDA Patient Safety News is basically the articulation of recent safety updates and concerns duly noted in text on the same web site, but presented in video form. Two professionally dressed hosts, one male and one female, sit behind a desk on a set fashioned after a typical television news show, with the FDA as a backdrop. The show appears to be a monthly production, and can be viewed as individual chunks by topic, or as a full webcast combining all of the videos, and therefore all of the updated safety alerts for that month, into one entire show.
However, a Chantix video alerting viewers to the potentiality of suicide and suicide ideation has mysteriously disappeared.
According to advocate John R. Polito, who edits why quit.com, the FDA posted the Chantix video clip, along with other video clips in its regular monthly update of health and product alerts. That was Tuesday, April 1st. However, by Thursday of that week Polito was reporting that the Chantix video clip was no longer available on the FDA website. Polito writes that he contacted the FDA to inquire as to why the video clip was pulled, and indicating that he had in his possession a copy of the video clip that he was intending to share via the whyquit.com web site. Polito also asked in his query to the FDA, if Chantix manufacturer Pfizer had played a role in the removal of the video.
That request was made, according to a screenshot on the whyquit web site, on April 3rd, with a follow-up April 4th.
As of yesterday, the link to the pulled FDA video on www.whyquit.com was not working, and the complete FDA video show, known as Show #74, also fails to work.
While the remaining video presentations related to other products play successfully, the Chantix video does not, nor does the full show, of which Chantix was a part.
It has not been determined why this video was pulled. However, it does underscore mounting concern over Pfizer's once-heralded anti-smoking pill that was initially designed to help smokers quit by blocking nicotine receptors in the brain. Such an action results in a much smaller release of dopamine in the brain, which is known to be responsible for the sensation of pleasure after a smoker inhales.
Since Chantix was brought to market in 2006 there have been hundreds of adverse effects reports—everything from weird dreams to anxiety, aggression, depression, suicide ideation and actual suicide. Pfizer beefed up the warning labels for Chantix in February, and the FDA is highlighting adverse effects once buried deep in product literature few consumers would bother to read. Meantime, the advocacy group Public Citizen is calling for a black box warning for Chantix, considered the strongest warning the FDA, and a manufacturer can issue for a product barring complete removal of the product from the market.
It has been reported previously that Chantix delivered a positive success rate, when compared to direct competitors such as Zyban, and compared with placebo, in clinical trials. Still, the majority of handpicked trial participants did not successfully quit smoking long-term, even with the intervention of regular counseling sessions. The latter would go far to help patients through the myriad of emotions that have been reported when Chantix is used alongside the normal challenges of attempting to quit what is for some, a lifelong and decades-long habit. However, it can be assumed that most patients attempting to quit on Chantix would not have the luxury of private counseling.
Further, Polito reminds us at whyquit.com that there is no credible data demonstrating that "Chantix is safe and effective for smokers having any significant medical condition, including alcohol abuse, as Pfizer intentionally excluded them from its five initial studies."
Polito goes on to say, "excluded groups truly are human Guinea pigs, rolling risk dice and now being experimented upon, most without any warning whatsoever."
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According to whyquit.com Chantix, also marketed as Champix in 20 European nations, achieved worldwide sales of $883 in 2007, its first full year of distribution. One could assume Chantix/Champix might be on track to reach the $1 billion plateau in 2008.
Doctors have since been warned to be extremely careful in prescribing Chantix, to ensure patient profile is the best possible fit for the risks, and nuances relative to Chantix. The FDA, meanwhile has Chantix under surveillance, and is carefully watching for continued reports of adverse reactions, or suicide.
Chantix users harmed by the drug, or those who have lost loved ones allegedly due to Chantix use may well be watching from the courtroom as part of a Chantix lawsuit.