2009 FDA ACTION UPDATE: Since the below article's original publication on April 2, 2008 the U.S. Food & Drug Administration (FDA) announced on July 1, 2009 that Chantix must carry a black box warning, the FDA's highest warning level. This FDA site link discusses the new warning and allows viewing of September 2009 FDA video on the black box warning update.
WARNING: As advised by the FDA and Pfizer, "If either you, your family or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if you develop suicidal thoughts or actions, stop taking CHANTIX and call your doctor right away."
WARNING: Do not rely upon any information in this article, including comments made by other Chantix users, to replace individual consultations with your doctor, pharmacist or other qualified health care provider.
WARNING: If you or your loved one is using or considering using Chantix or Champix be sure to read the new patient Medication Guide released on May 16, 2008. Also watch the safety warning video clip released by the FDA on April 1, 2008 (FDA website clip in various formats or WhyQuit link in Windows Media format only). If unable to watch the clips you can read warnings discussed in the clip at the FDA website.
Varenicline, approved by the U.S. FDA on May 11, 2006, is a quit smoking pill manufactured by Pfizer and marketed in the U.S. as Chantix and other nations as Champix. On May 16, 2008 the U.S. Food and Drug Administration and Pfizer updated Chantix's patient Medication Guide [Internet Archive link to old outdated May 16, 2008 Guide: DO NOT RELY UPON - for historical purposes only] to warn that users may experience changes in behavior, agitation, depressed mood, and suicidal thoughts or actions while using Chantix to help them quit smoking. According to the Guide, while some may begin experiencing these symptoms when they start taking Chantix, others develop them after several weeks of treatment or after ending Chantix use. According to the Guide, if you, your family or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if you develop suicidal thoughts or actions, stop taking Chantix and immediately call your doctor.
Users and family members should carefully read the entire Guide as aside from mental health warnings it contains a number of warnings regarding other side effects. Additionally the Chantix "Full Prescribing Information Sheet" should be read as it contains a complete listing of the more than 160 potential side effects that have been seen in Chantix users [link to current prescribing info - email for 2007/2008 versions].
April 1, 2008 the (FDA) released a video clip (YouTube copy), together with an announcement telling doctors and health care providers that the FDA has now linked Chantix to "serious neuropsychiatric problems" in users including behavioral changes, agitation, depressed mood (depression), suicidal thoughts and thinking and suicide. It is the clearest government warning yet of actual links between varenicline and life-threatening mental health concerns.
As shown by the many mental health comments shared below by users and surviving family, never in history has any quit smoking product produced such horrific side effects stories as are being played out among Chantix and Champix users.
A May 21, 2008 study by a medication watch-dog non-profit examined 6,363 varenicline FDA adverse drug reaction reports implicating Chantix and found that 3,063 involved serious injuries, including 78 deaths. It found that during the last quarter for which data is available, the 4th quarter of 2007, that Chantix registered more FDA adverse reaction reports than any other medication. It cautioned users to consider the use of alternative approaches to smoking cessation.
This all comes on the heels of latest clinical trial pitting Chantix against the nicotine patch, the results of destroy the widespread yet false belief that Chantix has proven superior to existing nicotine replacement therapy products.
Funded by Pfizer and published on February 8, 2008 in Thorax (link to free, full-text copy of the study), study participants in both the Chantix and nicotine patch groups were asked at 24 weeks and again at 52 weeks whether or not they had smoked within the past 7 days. Responses were verified by measuring exhaled carbon monoxide. Which group won? It was a draw. The authors found "no significant differences at week 24" "or at week 52."
But if you read the study's summary you'll see that the above statistical draw finding isn't mentioned. Instead, Pfizer declares Chantix a big winner. But how?
The full text study shows that Chantix users were given a week longer than patch users to adjust to brain dopamine pathway stimulation via varenicline (Chantix) prior to counting any continued smoking by particpants, even one cigarette, as a total and complete defeat (using a "continuous" cessation standard). Pfizer knew that a signifncant percentage of patch users would require a couple of days to adjust to dopamine pathway stimulation via the patch and used this fact to disqualify them using a "continuous cessation" standard.
But when looking at the actual percentage of particpants in each group who where not smoking at either the six-month mark or one year, there was was no statistically significant difference between patch and Chantix users. This pre-cessation adjustment period "slight of hand" was also recently seen a July 2009 pre-quitting nicotine patch study by the nicotine patch's co-inventor.
What's troublesome is that the FDA knew or should have known that the only way Chantix could be made to appear superior than NRT was by allowing Pfizer to play quitting definition shell games.
Official U.S. cessation policy, as reflected in the 2008 U.S. Clinical Practice Guideline declares that in compiling, comparing and presenting quitting method evidence that point prevalence stop smoking rates should be used, as using a continuous cessation standard undercounts successful quitters.
The 2008 U.S. Guideline update states that, "As in the 1996 and 2000 Guidelines, a point prevalence outcome measure (7-day point prevalence, when available), rather than continuous abstinence, was used as the chief outcome variable. Point prevalence was preferred for several reasons. First, this was the modal reporting method among the analyzable studies. Second, continuous abstinence data may underestimate the percentage of individuals who are abstinent at particular followup timepoints, although some data suggest that these rates are similar. Finally, most relapse begins early in a quit attempt and persists. A point prevalence measure taken at 6 months certainly would capture the great majority of those relapse events. Therefore, whenever possible, 7-day point prevalence abstinence data were used. If point prevalence data were not available, the preferred alternative was continuous abstinence data."
The July 2009 pre-quitting patch study suggests that had Pfizer researchers given patch users the same extra week to adjust to its use as was given Chantix users, that the likely closeness of performance results would have compelled the FDA to reflect long and hard about allowing Chantix to remain on the market.
What Pfizer's Chantix versus patch study did note was that two Chantix users experienced severe depression, with suicidal ideation causing one to be hospitalized 11 days after ending Chantix use. It found that among 376 Chantix users and 370 patch users that the likelihood of Chantix users experiencing vomiting was 5.5 times greater than among nicotine patch users, that decreased sense of taste was 5.3 times greater, abdominal pain was x5, disturbances in attention x4.5, nausea x4, flatulence x4, constipation x3, headaches x2, dizziness x2, diarrhoea x2, with 2.3 times as many Chantix users complaining of fatigue.
UK Stop Smoking Services may offer the highest caliber government sponsored cessation services of any nation. Services include free individual or group counseling and support. Figure 4.2 on PDF page 49 of a just released study analyzing program performance shows that at 4 weeks after starting varenicline treatment, that 63% of varenicline users were still not smoking as compared to 51% who quit without using any quitting product, and 48% using nicotine replacement products (NRT) such as the nicotine patch, gum or lozenge.
Keep in mind that these are 4 week results, that both varenicline and NRT users still face another 4-8 weeks of treatment before trying to adjust to living and functioning with natural brain dopamine levels. The only long-term UK program evidence, an April 2005 study, did not include varenicline. But bringing together all real-world data we have so far provides a rough sense of how Chantix quitters might compare at the 1 year mark in head-to-head competition with supported and counseled cold turkey quitters. It found that while 25.5% of those quitting without using any pharmacology were still not smoking at one year, only 15.2% of NRT quitters and 14.4% of bupropion (Zyban) quitters were still not smoking.
A February 8, 2007 Wall Street Journal story reported on real-world quitting method surveys showing that non-pharmacology cold turkey quitters performed as well as or better than those using nicotine replacement products, including a 2006 National Cancer Institute study. What smokers need and deserve is industry honesty and research integrity, factors missing from Pfizer's handling of varenicline.
Clearly, as shown below, it can no longer be asserted that Chantix is safe. As shown above, neither can Pfizer assert that Chantix offers meaningful improvement over existing nicotine replacement products. The only remaining question is whether or not real-world Chantix use will prove more effective than quitting without using Chantix. Although not conclusive, the early evidence clearly suggests that quitting on-your-own may actually prove superior. If true, it makes the below user horror stories even harder to accept.
The FDA's video clip openly admits a glaring defect in the FDA's drug approval process, that it allowed Pfizer to market Chantix to groups excluded from clinical trials. "During the pre-market studies of this drug people with serious psychiatric illnesses were not included and that means that the safety of the drug in these populations is really not known," the FDA's spokesman states.
Pfizer's chief defense to escalating mental health concerns is the implication that nicotine addiction and depression accompanying withdrawal are to blame, not Chantix.
"Nicotine is a very powerful addiction," asserted Ponni Subbiah, Pfizer's vice president of Medical Affairs at a June 5 press conference held at Pfizer's New York headquarters to defend Chantix. "We don't know what is causing what, but the withdrawal phenomenon is important to bear in mind and it is something we're going to have to do more research on."
The Wall Street Journal attended the press conference and reported that "Pfizer did say that smoking is associated with suicide." "One of the key points the company tried to make at the meeting was that depression - which is a risk factor for suicidal behavior - is not unusual in people who are trying to quit smoking," reported NewsInferno. "During its own key trials, Pfizer said that it did not see an increase in psychiatric events in patients taking Chantix compared with placebo," reported the Associated Press.
A June 11, 2008 Wall Street Journal editorial by Pfizer's chief medical officer implied that much of what he termed "sensational media reporting" was attributable to normal quitting symptoms or pre-existing underlying depression, not Chantix. "Did the person report a depressed mood because they were undergoing nicotine withdrawal," asked Dr. Feczko? "Did they smoke because they were depressed ? or was their depression caused by Chantix?"
According to the U.S. Surgeon General, "historically, the great majority of smokers (more than 90 percent) who successfully quit smoking did so on their own." Today there are 45.7 million U.S. ex-smokers. If Pfizer is correct and suicidal thinking and suicide are a normal part of quitting smoking, then where are the hundreds of news stories about cold turkey quitters killing themselves? Search as you might, I doubt you'll locate any.
Pfizer is using the normal sense of emotional loss felt when quitting without pharmacology as a smoke-screen to hide depression being chemically induced by varenicline's blocking effects.