Chantix

“If Chantix has been studied and has been found to have likely caused 98 deaths and an additional 188 attempted suicides and it is allowed to remain on the market because smoking cessation is such an important goal, then what is the point of removing e-cigarettes from the market while studying its potential adverse effects?” Dr. Siegel asked in his blog.

“Suppose e-cigarettes were to be found to have caused 100 deaths. Would that warrant taking it off the market, since it — like Chantix — is helping people to quit smoking?” he asked further.

“… unlike Chantix – for which there were many immediate post-marketing reports of potential adverse effects, e-cigarettes have been on the market for more than 3 years and there have yet to be any severe adverse effects reported,” Dr. Siegel said.

“In other words, we know that people are dying from taking Chantix but we’re going to allow it to remain on the market because it’s helping people to quit smoking. We know that there is no evidence that anyone is dying from using electronic cigarettes, but we’re going to take them off the market, even though they are helping people to quit smoking. That just doesn’t make any sense,” Dr. Siegel said.

Dr. Siegel also blames the pharmaceutical industry’s massive power to influence opinion, whether it’s a position taken by a consumer group, an erroneous statement made by a nonprofit organization, or the public opinion in general.

He notes that some anti-smoking groups are calling on the FDA to withdraw e-cigarettes from the market despite a lack of evidence suggesting they are harmful, yet the same groups do not advocate for the removal of Chantix, even though the drug tops the FDA’s list of most dangerous drugs.

“So far, every anti-smoking group which has called for the removal of e-cigarettes from the market has been found to be financially tied to Big Pharma. The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and Action on Smoking and Health have all received funding of some sort from the pharmaceutical industry,” Dr. Siegel said.

SOURCE: Chantix Recall › FDA favors Chantix over e-cigarettes. Why?

Subsequent attempts to quit involved Zyban, nicotine gum, nicotine patches, nicotine lozenges, various herbal “de-tox” remedies, and Chantix. I even bought this little gadget that punched holes in my cigarettes, allowing most of the smoke to escape through the filter. As ingenious as that device seemed to me, it was as frustrating as trying to drink with a broken straw. After a minute of sucking air, I simply got another straw that wasn’t broken.

Eventually, the only method I had left to try was the primitive, old-fashioned cold turkey method. Had electronic cigarettes been around when I was trying to quit, I assure you, I would have bought them.

The idea of an alternative cigarette is so appealing that many smokers probably have conceived of a fake cigarette at some point in their lives. I remember sitting on a long, trans-Pacific flight, experiencing the first withdrawal pangs from all the cigarettes I chainsmoked in LAX hours before, when the idea of inventing a fake “traveling” cigarette came to mind – basically just a flameproof, smokeless dummy that smelled and tasted like a real cigarette … an adult pacifier of sorts. But that was just pure fantasy to me.

Electronic cigarettes are like those fantasy cigarettes, only better. They are battery powered cylinders with chemically loaded cartridges that deliver vaporous nicotine and other substances. In other words, they simulate real cigarettes like nothing else on the market.

Unfortunately, new studies reveal that these e-cigarettes are not without their own dangers. The Food and Drug Administration has not approved them for use and therefore does not regulate them. However, the FDA has conducted lab analyses and says that e-cigarettes contain toxic chemicals such as diethylene glycol (an ingredient used in antifreeze) and other toxic and carcinogenic substances.

In fact, the agency is asking the public to report any adverse events or product quality problems associated with the use of e-cigarettes to the FDA’s Medwatch Adverse Event Reporting Program.

Perhaps smoking substitutes are destined to be like so many of the substitutes for sugar, salt, and fat – marginally satisfying replacements that eventually prove to have negative side effects and health risks that are just as bad or worse than the real thing. The FDA’s e-cigarette advisory should remind smokers that, like Chantix, not all smoking cessation methods and replacement therapies are safe and risk-free.

SOURCE: Chantix Recall › Are e-cigarettes too good to be true?

“People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away,” The FDA warns in its latest announcement.

The FDA also urges friends and family members to be observant of those using the medications, watching for behavioral changes in particular. The FDA said observers noticing such changes should “tell the person their concerns and recommend that he or she stop taking the drug and call a health care professional right away.”

Health officials are reluctant to withdraw smoking cessation drugs from the market even if the drugs prove to be dangerous for many people because smoking is the leading cause of preventable death in the U.S. Instead of an outright ban, they recommend taking the drugs with extreme caution.

In addition to boxed warnings on product labeling, the FDA will also require all adverse risks to be described in the drugs’ Medication Guides. The same regulations will also apply to generic versions of Zyban.

According to the FDA, analyses of both Chantix and Zyban users revealed disturbing patterns, noting that while many people stopped experiencing adverse affects once they discontinued the medication, others “continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.”

The FDA also said it will require the drug manufacturers to conduct new clinical trials to determine how frequently serious neuropsychiatric symptoms occur in patients undergoing various smoking cessation therapies. To help discern whether the drugs cause the symptoms or merely exacerbate them, the trials will include patients with and without psychiatric disorders.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Sources: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm

http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm169988.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm

SOURCE: Chantix Recall › FDA now requiring stronger warnings on Chantix labels

Wolbert, who has been a non-smoker for 30 days, attributes his success to seven-week group therapy session at Washington University’s Siteman Cancer Center. Like many others who have tried to quit smoking, Wolbert used Chantix unsuccessfully in his previous attempts to quit.

I can relate to Wolbert’s experience. I also used Chantix unsuccessfully for months, spending well over $400 for the drug. After a couple of weeks, I found that my cravings had dropped from a pack a day to half a pack a day, but they never subsided any more than that. I decided that I needed old fashioned will power to quit the other half pack. But my will power was in short supply. It was insufficient. But lack of willpower was why I started taking Chantix in the first place. The desire to quit was like being bound in a straightjacket.

Two months into my Chantix prescription, I realized that my progress had stalled. Another month and I heard the clock ticking. My 16-week Chantix regimen was three-fourths over and I never progressed beyond week two.

Worst of all, I hated the way I started to feel on the drug: sluggish, prone to fits of depression and self-pity, some of the worst anxiety I have ever experienced, an inability to focus, forgetfulness, absent mindedness, an aversion to social occasions, and intense dreams that seemed to stamp my days with a residual “cruddy” feeling.

I stopped Chantix right after FDA warnings about a possible link between the drug and suicide emerged. I could imagine myself going down that path if I continued treatment.

I mostly felt like myself again about 4 days after stopping Chantix. The exceptions were that I had a high anxiety level and an inability to concentrate. At first I thought these symptoms were related to reduced nicotine intake, but the problems grew worse even after I started smoking more and more.

I wondered if there was such a thing as Chantix detox. I researched the idea online but couldn’t find anything. I turned to natural, holistic methods of nicotine and drug detoxification. I just wanted Chantix out of my body and out of my brain.

Several months after I became a Chantix dropout (which was a difficult fact to face given that Chantix is the most widely hailed smoking cessation therapy ever) I decided I had had enough of thinking about quitting and trying to quit and promising to quit. I just needed to quit, period, before I lost my sanity.

I became a non-smoker by following the advice of Allen Carr, the smoking cessation guru whose books and “Easyway” seminars have helped many people around the world quit smoking without the use of drugs and nicotine replacement therapies.

Carr died a couple of years ago, but while he was alive he claimed his program had nearly a 100% success rate in getting people to stop smoking permanently and without withdrawals. Moreover, Carr claimed his program required no willpower whatsoever. I laughed at that idea at first.

Carr taught people how to navigate the mental labyrinth that smokers become lost in after they abstain from cigarettes. He called this the “nicotine trap,” and came up with more ways than Houdini to escape it.

Carr taught me to recognize the physical sensations of nicotine withdrawal; not to fight them or grit my teeth in resistance or try to squash them out but to just sit in quiet acceptance and observation of them whenever they emerged. In doing so, I realized that nicotine withdrawal and cravings weren’t as bad as everyone says they are. In fact, merely observing the physical sensations of these nicotine fits would cause them to subside almost as quickly as they came.

There was, of course, much more to his program, but understanding and accepting what I experienced was essentially what helped me to quit. Other parts of Carr’s program served as “get out of jail free” cards every time I had an urge to smoke.

As Eric Wolbert of St. Louis suggested, and as Allen Carr himself advised, smokers should regard quitting with anticipation and delight, never with fear and dread. That may sound like an impossible task to someone locked within the “nicotine prison,” but many programs and seminars exist that give smokers the right tools need to unleash the simple but incredible power of their minds … and to step outside of nicotine’s clutches once and for all.

SOURCE: Chantix Recall › Note to Chantix flunkees: there’s still hope even after the magic pill fails