The writer, who dissects some of her own experiences with Chantix, lends credence to the bare-bones clinical trials that are often all that is necessary to successfully get a new product onto the market. Some have even gone so far as to say that in the current approval environment, the onus is not to prove that the subject product is SAFE, but rather that there is reasonable improbability that the product would be found NOT to be safe.
Thus, any concerns, which appeared to be minimal at the clinical trial stage of an emerging product, would presumably and quite understandably be exacerbated once usage of the product has multiplied in tandem with thousands, if not millions of users.
Further, it has been reported that Chantix clinical trial participants were not a true representation of the smoking sector, given that many scientists are of the view that smokers as a group have a higher incidence of physical, as well as emotional illness and psychosis, than non-smokers.
In the Chantix clinical trial, it has been reported that such participants were weeded out. Still, according to information on the prestigious Mayo Clinic's web site, a sizeable majority of participants—even with weekly counseling sessions—could not manage to stay smoke-free beyond the Chantix program period, or within a year after concluding.
In fact, on the surface it appeared that the Chantix success rate appeared laughingly low. However, it compared favorably when put up against Zyban, an anti-depressant used as a smoking cessation tool. And—an easy stretch—Chantix did well when compared against participants trying to quit smoking, but taking a sugar pill instead.
Since Chantix hit the market, the US Food and Drug Administration (FDA) has been inundated with scores of adverse reactions reports. Users report wild mood swings, disturbing dreams, anxiety, aggression, and the most serious of all—suicide ideation. While the latter was minimal, if even a no-show in clinical trials, given the size of the smoking population and the glee with which the smoking community has embraced Chantix as the answer to their prayers, it's little wonder such reports are coming in.
Some of those reports are disturbing, as there have been well over 30 actual suicides linked to the use of Chantix.
The idea behind Chantix was to shield certain receptors in the brain from receiving, or responding to nicotine. Without Chantix, these receptors foster the release of dopamine, which is responsible for the pleasurable feeling when lighting up. When the nicotine is blocked, dopamine levels are minimized, effectively stemming the pleasure derived from smoking.
While this loss in pleasure has worked well for some people ('well gee, if the cigarettes don't do anything for me any longer, then why bother?...'), it has proven distressing for others—especially individuals driven to take a puff after their resolve has abandoned them, only to find with horror that the illicit cigarette provides no pleasure whatsoever.
And that's the point made by Danforth: that individuals react differently to Chantix. In her case, she found that Chantix made her more productive as a writer. She describes bursts in creativity, in energy and of insomnia that was nothing short of unsettling. While her output was unparalleled while she was on Chantix, the hypergraphia (the manic need to write) was exhausting, and "the brain buzz got to be too much." The writer attempted to modify the dose without success, and finally quit Chantix altogether before going back to smoking.
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One can imagine that given the complexities of the human mind, a typical response to Chantix simply does not exist. And depending on the individual, a person could wind up with any combination of adverse effects. Or all of them. Or none of them.
You just don't know.
And that's the scariest part.
The FDA is continuing to investigate reports of Chantix adverse effects, including actual suicide, and suicide ideation. In the meantime Chantix users, some of whom have recovered from pretty horrendous adverse effects, are contacting a Chantix lawyer.