Pfizer mixed reports of serious problems among 26,000 records of non-serious side effects such as nausea and rashes.
According to MSNBC:
“Pfizer officials said ... there's no proof that Chantix causes suicide or other serious side effects ... In the third quarter of 2010, [Chantix] ranked first in reported deaths, with twice as many fatalities logged as any other drug”.
The decision to quit smoking is an important and powerful preventive action, but please think long and hard before you decide to take the stop-smoking drug Chantix to help you do so. This drug may cause an inordinately high number of serious side effects, including suicides and psychotic reactions where people with no history of violent behavior suddenly kill themselves or others after taking the drug.
There are currently hundreds of lawsuits pending against Pfizer (the drug's manufacturer) alleging that Chantix caused serious injury or deaths. This includes one case where a man suddenly shot himself and his wife in what their families describe as a "Chantix-fueled rage."
To get an idea of just how risky this drug appears to be, an analysis by the non-profit Institute for Safe Medication Practices (ISMP) found that in the third quarter of 2010, Chantix:
- Surpassed all other regularly monitored drugs in terms of adverse events
- Ranked first in reported deaths, totaling more than twice as many as any other drug they regularly monitor
- Accounted for more possible cases than any other drug for suicidal/self-injurious behavior, depression, psychosis, hostility/aggression, and convulsions.
Chantix has had a troubling history since it was first approved by the U.S. Food and Drug Administration (FDA) in 2006. In 2008, ISMP also found that adverse event reports for the drug outnumbered those for other prescription drugs on the U.S. market, including notoriously toxic chemotherapy drugs. In 2009, the drug received the stringent black box warning (the strongest warning possible) to warn users of the suicide risks, but now it turns out the suicides may have been even more common than previously thought.
Pfizer Submitted Side Effect Data Through "Improper Channels"
The ISMP analysis revealed another troubling turn of events in the Chantix saga, which is that the drug's manufacturer had been submitting safety data to the FDA through "improper channels" for years.
"The third quarter totals for 2010 had been boosted by 589 reports about serious and fatal adverse events that had occurred in prior years but were not entered into the FDA AERS [Adverse Event Reporting System] system until July 2010. We found 12 newly entered cases with manufacturer dates from 2006, the year varenicline [Chantix] was first approved, 119 from 2007, and 176 additional cases from 2008.
The rest of the 589 cases were for 2009 and early 2010, but also not entered into the reporting system until July 2010 or later.
Prominent among these newly available cases were 150 completed suicides identifying varenicline as the primary suspect drug. These additional cases more than doubled the total suicides that were in the AERS system and available to the FDA and others for safety analysis."
Apparently the data was not found earlier because Pfizer was submitting only periodic reports on adverse events to the FDA, which is all that is required of side effects that are "less serious" or already noted on the label or "expected."
Because suicides had already been identified as a risk of Chantix, they were labeled as "expected" and did not need to be reported through the expedited system that the FDA requires companies use to report serious and unexpected adverse events.
Further, Pfizer grouped hundreds of cases of suicide, suicide attempts, and psychosis in with more than 26,000 mostly non-serious side effects in a text report format rather than inputting them into the AERS system that the FDA searches to identify reports that might signal a safety issue for additional study.
"To classify a suicide or suicide attempt as an "expected adverse event" rather than submitting it promptly as a 15-day report where it would have been immediately available is troubling in our view. Additional questions arise about how Pfizer coded hundreds of reports of depression and suicidal ideation.
When the FDA surveillance system did not include more than half the reported suicide deaths in which varenicline was primary suspect drug, it is a safety lapse that warrants careful investigation."
Pfizer also reportedly received a warning letter from the FDA in May 2010, indicating deficiencies in the company's reporting of adverse events. ISMP reported:
"Among the violations the FDA alleged had occurred were failure to submit serious adverse event reports for cases already in company files until identified by an inspector, misclassifying and downgrading events without reasonable justification, and failing to submit expedited reports within 15 days as required.
The agency also alleged Pfizer had failed to keep prior commitments to improve training and performance for adverse event reporting. The specific cases cited as examples in the letter did not include varenicline but applied broadly to Pfizer's safety surveillance program."
How Does Chantix Work?
Chantix works directly in your brain to ease nicotine withdrawal symptoms, which may help explain why it appears capable of causing extreme mind-altering behaviors.
The main ingredient in Chantix, varenicline, causes the release of dopamine within your brain while blocking nicotine from occupying your alpha 4 beta 2 receptors. Many antipsychotic drugs block dopamine receptors, but they're also known to cause movement disorders. (For example, the loss of muscle control seen in Parkinson's disease is the result of the destruction of dopamine-producing cells in your brain.)
Your alpha 4 beta 2 receptors play numerous roles in your brain and are central to your muscle's ability to properly contract. This includes both voluntary movement, and involuntary muscle contractions such as your heart muscle, and the smooth muscles that line your blood vessels.
The drug decreases your ability to feel pleasure (by blocking your brain's pleasure centers), which can lead to severe depression, and in addition it may also wreak havoc on your heart and cardiovascular health. Most notably, though, are the potential implications this drug may have on your psyche. Among the many psychiatric and other potential side effects listed on the Chantix Web site are:
Changes in behavior, thinking or mood Hostility Agitation Depressed mood Suicidal thoughts or actions Anxiety Anger Mania Abnormal sensations Hallucinations Paranoia Confusion Nausea and vomiting Sleep problems (trouble sleeping, changes in dreaming) Constipation and gas
A Safer Plan to Stop Smoking: Step One, Address Your Diet
Chantix is in no way an essential drug, and in my opinion the risks of taking this drug far outweigh the potential benefits of stopping smoking. One needs to be very careful about jumping out of the frying pan into the fire. A similar example would be having your mercury amalgam fillings removed by a non-biological dentist who will release loads more mercury into your system and cause you serious harm.
However let me make myself very clear -- I do NOT recommend smoking, and I suggest quitting to be optimally healthy (and for the health of those who live with you) -- but using a toxic drug like Chantix is just not a wise solution.
In my experience there is a great deal of confusion surrounding aggressive stop-smoking recommendations. Most experts advise this as a primary recommendation and pay little attention to a person's diet.
This is unfortunate, as when most people stop smoking they tend to reward themselves with junk foods as a substitute for their cigarette addiction. As a result they can easily gain a lot of weight. Obesity has been associated with higher rates of chronic medical problems and a poorer quality of life than smoking, so it is not a smart trade.
If you are currently overweight or obese AND a smoker, I strongly suggest you work on improving your diet and achieving your ideal weight BEFORE you attempt to quit smoking. But even if you're not overweight, my advice is the same -- get your nutritional program on track first, then tackle the cigarettes.
Eat for your nutritional type, eliminate sugar (especially fructose) and grains, and make sure to consume adequate amounts of omega-3 fats. These three powerful steps in the right direction will put you well on your way to good health, and then you can tackle the smoking head-on.
Tips to Stop Smoking
The dietary improvements mentioned above will go a long way toward helping you give up nicotine. Good nutrition will minimize feelings of depression you may encounter when you quit smoking, and you'll feel healthier in general, which can help motivate you to stick with your decision to quit.
When you do decide to stop, one of the best and safest ways to quit smoking is cold turkey. In the long run, smokers who quit cold turkey do better than those who used "helps" like nicotine gum, the patch, or stop-smoking drugs.
If you do need some help along the way, I highly recommend you take advantage of the Emotional Freedom Technique (EFT), which can help you break the habit and also deal with the emotions you experience when you quit.