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Serious controversy brewing: are Chantix and Champix safe?
This article was originally written in August 2006. Since then there has been mounting concern regarding varenicline’s safety. Due to a number of recent developments, this article’s safety discussion is presented in chronological order. Each underlined date is a link to the development’s online source.
May 10, 2006 - The FDA approves Chantix’s Patient Information Sheet. The “Sheet” warns [...]
Those who don’t know cessation study history are destined to repeat it
Chantix entered the quitting product market as a prescription aid at a time when nicotine replacement therapy or NRT was the clear front-runner. Nicotine gum was first approved by the FDA for prescription use in 1984 and was followed by the nicotine patch in 1991. Both the gum and patch were approved for over-the-counter [...]
Pfizer’s five initial clinical trials of varenicline were published in July and August 2006. Three are comparable in that they involved a 12-week treatment period using 1mg of Chantix twice daily. In the Chantix study headed by Gonzales, 21.9% of Chantix users were still not smoking at one year. In Oncken the rate was 22.4% and in Jorenby 23%.
That’s an average one-year rate of 22% [...]
“What’s it like using varenicline?”
On May 11, 2006 the U.S. Food and Drug Administration (FDA) announced approval of the prescription drug varenicline, to be sold under the trade name Chantix. Today it is marketed as Champix in 20 European nations (including England and Scotland), Australia, Korea, Brazil, Mexico and Japan, with 2007 worldwide sales of $883 million (see PDF page 37). Interestingly, in the U.S. [...]
“Does Chantix really work?”
”Tell me the truth, what are my chances?” Frankly, not good. Putting aside for the moment growing concern over FDA acknowledged links between Chantix and suicide, if Chantix (whose chemical name is varenicline) is used as a stand-alone quitting aid without ongoing counseling or support, your chances of quitting smoking for one year are probably less than 1 in 11. But when [...]