The new study, published in the Canadian Medical Association Journal, included the results of 14 random, blinded clinical trials that monitored cardiovascular health in more than 8,000 patients taking either Chantix or a placebo. Collectively, the trials found that 52 smokers in the Chantix groups suffered a heart attack, stroke, or other serious cardiovascular event while just 27 smokers taking placebo experienced the same cardiovascular problems. According to the New York Times, the “weighted, relative difference” between the two groups was 72 percent.

In the real world, the findings of these two latest Chantix studies mean that “doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug,” the New York Times reported.

“We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A.,” said Dr. Curt D. Furberg, a Wake Forest professor of medicine and senior author of the new report. “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.”

Dr. Furberg said that there were safer ways for smokers to quit and called for Chantix to be removed from the market.

“It piles up,” Dr. Furberg told the New York Times. “I don’t see how the F.D.A. can leave Chantix on the market.”

The study’s lead author, Dr. Sonal Singh, an assistant professor of medicine at Johns Hopkins University, said that since Chantix gained market approval in 2006, both Pfizer and the FDA have ignored signs that it might be linked to increased cardiovascular risks.

“The F.D.A. should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”

“This would have raised a red flag for us if the flag hadn’t already been flying,” Dr. Celia Winchell, a leader in the FDA’s Center for Drug Evaluation and Research told the New York Times. However, short of a recall, the new findings are likely to have little impact on the FDA’s treatment of Chanitx because the drug already carries the agency’s strongest black-box warnings.

Since its debut, Chantix has been prescribed to 13 million people. Last year, the drug earned Pfizer $775 million in sales.

SOURCE: Chantix Recall › Chantix significantly increases cardiovascular risks, according to another new study

The FDA said that a randomized, double-blind, placebo-controlled clinical trial of 700 smokers were given Chantix or a placebo. All of the participating smokers had been previously diagnosed with heart disease. Although results found the risks to be relatively small, after 12 weeks more than twice as many Chantix patients suffered heart-related problems than the placebo patients. Seven out of 353 Chantix patients had a nonfatal heart attack, versus 3 out of 350 of the placebo patients.

Other adverse events reported to be more frequent in the Chantix group included angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

The FDA advises that patients taking Chantix should check with their doctor if they have new or worsening symptoms of heart disease, such as difficulty breathing, chest pain or pain while walking.

Shortly after Chantix first became available in the U.S. in 2006, patients began reporting negative side effects to the FDA, most notably for suicidal thoughts and actions. In 2009, the FDA required Chantix to carry a black box warning, the agency’s strongest warning, because of persistent complaints about depression, violent mood swings, vivid dreams and nightmares, and suicidal behaviors.

Source:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm259469.htm

http://www.chantix-legal.com/news/2009/07/01/fda-now-requiring-stronger-warnings-on-chantix-labels/

http://www.chantix-legal.com/news/2011/05/31/chantix-suicides-and-violence-much-more-common-newly-found-reports-show/

SOURCE: Chantix Recall › FDA warns of new heart risks associated with Chantix

WhyQuit reports that in surveys and scientific studies, more people were found to have successfully quit smoking long term using the cold turkey method than nicotine replacement therapies (NRT). NRT delivers smokeless nicotine to the user through chewing gum, lozenges, patches, and nasal sprays. NRT manufacturers typically tout their products as effective ways to ease nicotine withdrawal symptoms, which, in theory at least, should help smokers to quit. However, the vast majority of NRT users either resume smoking or become as addicted to expensive nicotine gum, patches, and lozenges.

Although no studies have compared cold turkey to Chantix, researchers have studied Chantix against NRT. While one study showed that Chantix appeared to be more effective than NicoDerm CQ in the short term, after a year, the success rate was statistically the same for both Chantix and NRT users. According to WhyQuit, the study forced Pfizer researchers to report that there were “no significant differences” between Chantix and NRT, but Pfizer’s ads do not mention the statistic.

If cold turkey is more effective than Chantix, and NRT is about the same, “why assume Chantix’s long list of serious use risks in exchange for little or no benefit?” WhyQuit asks.

The organization says that without support, “Chantix is probably worthless.” While counseling and support have proven their ability to drastically boost the chances of quitting permanently, Chantix has never been tested as a stand-alone smoking cessation aid. The drug is packaged with a support plan that includes a toll-free number and a web site to which consumers may turn for extra support. Pfizer hasn’t said what percent of Chantix users take advantage of the support program, but if the support seekers were subtracted from the total number of successful Chantix quitters, then the success rate would likely plummet.

Also, if Chantix were as helpful as Pfizer claims, then smoking rate in America ought to be descending. Since Chantix first appeared on the market, however, the adult smoking rate actually increased by one percent.

A third point of contention WhyQuit makes concerns the placebo studies that researchers conducted to gauge the effectiveness of Chantix. “Use of placebo controls in drug addiction studies is license to steal,” WhyQuit says, asserting that test subjects who experience severe withdrawal symptoms certainly know that they’ve been given a placebo rather than a drug that is supposed to mitigate those symptoms. Such studies allow Pfizer to exaggerate the efficacy of Chantix.

Fourthly, WhyQuit calls Pfizer out on its ads displaying people who claim, “I honestly love smoking,” saying that the ads mess with the drug-addicted brains of smokers. Pfizer adds appeal to Chantix by telling consumers that they may continue to smoke through the first week of treatment.

“It isn’t that we loved smoking but that we didn’t like what happened when we didn’t smoke,” WhyQuit claims.

“Drug addiction is about living a lie,” WhyQuit says. A dopamine reward pathway that convinces the addict that “nicotine use defines who they are, gives them their edge, helps them cope and that life without smoked nicotine would be horrible. Pfizer knows this and is now playing upon it.”

Finally, WhyQuit asserts that “what Pfizer will never teach smokers is that cold turkey accounts for far more long-term success stories each year than all other quitting methods combined.” After 3 days of nicotine abstinence, physical withdrawal symptoms dissipate and the brain works to heal its receptors. Counseling and support help cold turkey quitters with the emotional and psychological aspects of quitting smoking.

SOURCE: Chantix Recall › Support group says Chantix ads conceal important information

Reynolds American

Based in Helsingborg, Sweden, Niconovum produces nicotine-replacement therapies (NRTS), smoking cessation products designed to provide users with a smokeless form of nicotine relief. Niconovum’s products are Zonnic pouches (small bags containing a nicotine powder that users put beneath their lips), Zonnic “pepparmint” [sic] mouth spray, and Zonnic gum.

SmarTrend’s analyst points out that both Reynolds and the Altria Group, owner of Philip Morris USA and other tobacco product companies, own pharmaceutical companies, but Reynolds’ purchase of Niconovum would be the first time a tobacco giant marketed and sold a smoking cessation product.

According to the Wall Street Journal, “the potential deal would mark the latest and most dramatic move by Reynolds into nicotine products that represent alternatives to cigarettes.”

“Sales of cigarettes in the U.S. have been declining for years, prompting Reynolds to move into products that studies have shown present much smaller health risks than cigarettes,” the WSJ explains.

Reynolds’ acquisition of Niconovum might seem contradictory and even hypocritical, but it makes good sense for the tobacco company. Some smoking cessation experts allege that many people who use nicotine replacement products wind up addicted to expensive gums, lozenges, patches, sprays, pouches, and other products. The smoking cessation market, already a multi-billion-dollar industry, is expected to continue its dramatic growth in the next ten years.

“Help people quit smoking, but keep them addicted to nicotine” seems to be the business model Reynolds America follows in its purchase of Niconovum.

SOURCE: Chantix Recall › Reynolds closer to buying smoking cessation products company

Regular “light” cigarette brands contain 20 times the amount of nicotine as VLN cigarettes, a release by the manufacturer states. Even low nicotine cigarettes contain about 8 times more nicotine than a VLN cigarette.

Studies have shown that “Differences in nicotine content of cigarettes have significant implications for compensatory smoking, dependence, and efficacy in smoking cessation,” according to the manufacturer.

Research conducted so far indicates that VLN cigarettes may prove to be one of the most effective smoking cessation inventions yet. Although VLN cigarettes have yet to be tested in large clinical trials, they have been tested in a number of smaller, independent studies. In each of the studies, VLN cigarettes increased quit rates, whether they were used exclusively or in combination with nicotine replacement therapy (NRT), such as nicotine gum, lozenges, and patches.

A University of Minnesota trial suggested that using VLN cigarettes alone boosted smoking cessation success rates more than NRT.

43 percent of patients who used VLN cigarettes exclusively continued to be smoke-free after 4 weeks of continuous abstinence. The success rate for patients using NRT was just 28 percent.

A pair of studies conducted at Duke University, which set out to measure and compare the strength of nicotine cravings with the actual smoking habit, supported these findings.

The Duke studies found that the urge to light a cigarette is sometimes “more compelling than the physical need for a nicotine fix.”

In light of that finding, it’s no surprise that researchers found VLN cigarettes more effective in helping smokers to quit than NRT. VLN cigarettes gradually wean the body from nicotine as the user smokes. With NRT, the smoker stops smoking altogether but continues to feed the body nicotine, usually to “take the edge off” of smoking cravings. Very commonly, however, ex-smokers end up addicted to various forms of NRT even though they have successfully quit smoking.

Another smoking cessation approach, of course, is to use pharmaceutical therapies such as Chantix or Zyban (also known as Wellbutrin). One problem, however, is that these drugs don’t adequately address the habitual side of smoking. They may mitigate the effects of nicotine withdrawal, but after the quit date, the patient is left to cope with the sudden absence of a psychological “crutch.”

More importantly, however, is the safety factor. Because they already smoke, people who use VLN cigarettes do not introduce any new chemicals or other compounds to their bodies, thereby exposing themselves to a range of dangerous and occasionally deadly side effects.

Chantix has been linked to several side effects ranging from mild to severe and including:

• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• sore throat
• headache
• blistering, peeling skin rash
• nausea, vomiting
• stomach pain
• indigestion
• weakness
• fatigue
• increased appetite
• unpleasant taste in mouth
• headache
• sleeping problems
• vivid and unusual dreams
• mood or behavior changes
• agitation, hostility, depression
• suicidal thoughts

SOURCE: Chantix Recall › “very low nicotine” cigarettes may become sound alternative to Chantix

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?

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

The Journal Sentinel explains that Wisconsin physicians must complete 30 credits worth of continuing medical education (CME) courses every 2 years by law. The courses, which UW offers online, earn doctors up to 2 credits per course. Of the 9 online CME courses, the Journal Sentinel found that 4 were funded by pharmaceutical companies. Doctors may take those courses free of charge, but must pay a fee to enroll in any of the university-funded courses.

Pfizer is one of the companies funding an online course at UW that instructs doctors how to help their patients quit smoking. Pfizer gave UW $12.3 million for the course, which showcases Chantix as the latest and greatest smoking cessation method. The course materials do not mention the serious risks of taking Chantix, even though numbers pulled from the Food and Drug Administration’s Adverse Event Reporting System revealed that Chantix topped the list of the country’s most dangerous drugs.

Chantix has developed a favorable reputation among some people who have successfully quit smoking while taking the drug, but it has also been linked to a number of suicides and other episodes of abnormal and psychotic behavior.

Another CME course on premenstrual dysphoric disorder offered by UW is also funded by Pfizer. The course was designed by psychiatrists who have financial ties to the drug company. The course cites Xanax as a form of treatment for the disorder, “but fails to point out that only 37% of women who took it had significant improvement, compared with 30% who got a placebo.

The course also does not mention Xanax’s side effects, including the potential of dependency,” said the Journal Sentinel. “Several of the drugs promoted in the course are not approved by the FDA to treat the condition and have serious side effects not mentioned on the course Web site, including depression, stroke and blood clots,” the paper reported.

The Journal Sentinel points out that no written agreement between the drug companies and the university exists, but reciprocation is nevertheless expected.

“What you are seeing in Wisconsin is just another example of what is going on all over the country,” Arnold Relman, professor emeritus at Harvard Medical School and a former editor of the New England Journal of Medicine, told the Journal Sentinel.

“It’s unethical, and it is not in the public interest because it is going to bias doctors to use certain drugs,” he told the paper.

Daniel Carlat, a clinical professor of psychiatry at Tufts University Medical School, told the Journal Sentinel that “drug companies have found this to be a highly effective way to attract the attention of physicians.” To stay licensed, doctors must enroll in the classes. Therefore, companies such as Pfizer have a captive audience, he explained.

According to the Journal Sentinel, “Critics say the practice increases medical costs by encouraging doctors to write prescriptions for expensive brand-name drugs and by exaggerating the frequency and prevalence of rare conditions. It also promotes the use of drugs not approved for the ailments.”

Ten years ago, pharmaceutical companies spent $302 million on doctor education courses. In 2006, that amount had swollen to $1.2 billion.

“Drug companies have essentially hijacked the highest level of medical education we have in this country,” Carlat told the Journal Sentinel.

SOURCE: Chantix Recall › Pfizer and other drug companies fund medical courses

Promoting the embattled and controversial drug will now be the responsibility of mcgarrybowen, which is a subsidiary of the Japanese ad giant Dentsu. Pfizer had been using McCann HumanCare to promote Chantix since 2007. Since that time, the drug has been linked to depression, suicide ideation, moodiness, erratic or unpredictable behavior, and a spectrum of other potentially deadly psychological and physical side effects.

Pfizer, who normally outspends its competition promoting its products, reportedly spent more than $60 million on advertising for Chantix last year. The massive sum, however, apparently was still not enough to turn the tide. The number of Chantix prescriptions tapered off in North America ever since the drug earned top spot on the list of America’s most dangerous drugs. In the final quarter of 2008 they began to drop.

Chantix may be falling short of blockbuster expectations, but for now its appeal is situated in an odd place — a place between knowing that it could kill you and knowing that smoking will almost certainly kill you. For many people, it may just be the lesser of two evils.

Will mcgarrybowen capitalize on that premise (take the honest approach) or just ignore that Chantix is the most dangerous FDA-approved drug in the country right now? It’s anyone’s guess what will replace the old tortoise and the hare.

“The needs of the Chantix brand continue to evolve,” a Pfizer representative said in a report published by Adweek.”Mcgarrybowen presented us with very innovative ideas that we feel best meet the needs of this brand at this time.”

SOURCE: Chantix Recall › Chantix sales fall, Pfizer fires ad agency

Health Canada

Last month we reported that Health Canada was preparing to strengthen warnings on Chantix labels. However, Health Canada still has not taken action.

In a report by the Canadian Broadcasting Corporation, Health Canada sent the CBC an email saying that “new advice for health professionals and Canadians will come in the near future.”

Meanwhile, Chantix continues to jeopardize the lives of many Canadian citizens, some of whom are not aware of the drug’s risky side effects.

According to the CBC report, Hamilton resident Erin Kerr had been taking Chantix for two months when she realized her personality had shifted and she had become intolerant, argumentative, and emotional, all of which were unlike her usual self.

Then one day the changes became even worse. Kerr found a sudden irrational appeal in taking her own life. She described her experience to the CBC.

“As I’m driving along the [Hamilton] mountain brow, I just thought that driving off … would have been the easy way out at that point and would solve all my problems,” she said.

Fourteen-year-old Ellaina Janewicz lost her father Thom Janewicz early last month when he committed suicide. His ex-wife, Gayle Nakamoto, said that Thom had struggled with depression in the past, but that it seemed to be “under control.” Thom was a 48-year-old engineer and was about to begin a new job when he started taking Chantix.

Ellaina keeps a journal to help her cope with her loss. She read an excerpt of it to the CBC.

“What will I do now? I have no father,” Ellaina said, reading from the journal. “I’m here with my mother alone and my brother. I’m very confused. I’m not sure what to do.”

In the United States, the Food and Drug Administration strengthened its warnings a year ago. Despite the new warnings, however, the FDA still received more reports of adverse effects linked to Chantix use than any other drug.

SOURCE: Chantix Recall › More Canadians harmed by Chantix as government revises warnings

The decision to turn the volume up on Chantix warnings follows several months of reports linking the drug to a slew of negative side effects. Feeling unusually agitated, depressed, or hostile are some of the effects commonly reported. Sudden changes in behavior, impulsive or disturbing thoughts, and the desire to hurt oneself or others are some of the more serious reactions reported.

In the United States, the Food and Drug Administration received more reports of serious injuries arising from Chantix than for any other drug. Prescription drug related death, which normally accounts for 16 percent of all serious reactions reported to the FDA, soared to 23 percent in the first quarter of 2008, largely because of Chantix. The U.S. has since strengthened warnings on Chantix labels.

Health Canada says that while Chantix can be an effective aide in quitting smoking, users of the drug and their families should closely monitor behavior for any changes. Sudden shifts in mood, depression, aggression, and thoughts of self harm are red flags that everyone should watch for. The person taking Chantix should avoid driving and operating heavy machinery until they know that Chantix does not have any adverse effects on them, Health Canada recommended.

Pfizer’s spokesman in Canada, Christian Marcoux, said that Chantix is safe and that some of the adverse side effects are actually caused by quitting smoking.

SOURCE: Chantix Recall › Canada strengthens Chantix warnings

For many people, however, (including me), the Chantix experience isn’t one of wild extremes. It’s more like a strange trip through life with a brain that feels somehow different from the brain you had before. You feel normal and behave normally most of the time, but occasionally you find yourself saying or doing something that is not you, and the realization that accompanies this uncharacteristic behavior leaves you feeling disembodied and maybe even a little crazy.

New York magazine recently published an excellent article by a guy who recounts his own journey through a landscape made murky by Chantix. If you are one of the people who are seriously considering taking Chantix but trepidatiously wonder what it will be like for you, read Derek De Koff’s story, which echoes the experiences of so many people in blogland.

De Koff writes, “After a few weeks on Chantix, I had managed to stop smoking altogether—but it didn’t feel like a triumphant turn of events. I’d become rather reclusive, avoiding calls from friends, and basically just shuttling back and forth between my office and my apartment. I began to dread six o’clock; it meant I had to walk through the streets again. The subway was now out of the question; it made me too nervous. I stopped going to the gym, too.

“I wondered whether Chantix was zapping my brain’s pleasure-delivery system to such a degree that not only did I find no reward in cigarettes, but I also found no reward in socializing, exercising, writing, or any of my usual self-stimulating tricks. I’d pace the floor, sit on the bed, channel surf, pace some more, try to read, but the room had a stale, sinking feeling.”

So many people have such enormous expectations of Chantix, but the basic truth is that it may work for you (at least in the short term) and it may not work for you at all. If you decide to use it, monitor your behavior closely. I’m one of the people who took Chantix unsuccessfully. Ultimately it was the power to control my own thoughts that worked for me, bolstered by the fact that I had spent hundreds of dollars on a drug that did nothing but make me feel weird, half crazy, and “out of it” most of the time.

SOURCE: Chantix Recall › The Chantix experience: salvation, downfall, or just plain strange?

Now the country is seeing a near-perfect reversal of the 1990s trend. The number of new cancer cases has shrunk nearly one percent on average from 1995 to 1999. The death rate among cancer victims has decreased by nearly two percent from 2002 to 2005.

Researchers attribute the decline in cancer to a parallel decline in smoking, noting that cancer mortality rates would have remained virtually unchanged if Americans hadn’t quit and refrained from starting in larger numbers as they have been doing.

The Centers for Disease Control and Prevention (CDC) released a November report showing that nearly 21 percent of adults smoked in 2004. However, in 2007, the number of adult smokers dropped to under 20 percent.

It’s true that the smoking cessation market has exploded in the last 15 years with a remarkable number of gums, patches, devices, and prescription drugs. And, although more and more people continue to quit, the drop in smoking appears to be tethered to prevention and social initiatives more than anything else.

So just what are the most effective ways to slash smoking rates? Make smoking costlier by hiking tobacco taxes and make it more inconvenient by banning it from public areas, researchers say. Educating young people and providing counseling during smoking cessation are also effective ways to keep the smoking numbers down.

A lot of people may argue that a smoker has enough willpower to smoke no matter how inconvenient and expensive it becomes. As someone who used to smoke, I agree with that argument. But I also know that the growing inconvenience was accompanied by the growing aggravation of constantly having to plot and plan ahead and work around the rules and worry, often in advance, about the next opportunity to light up. And that in turn nurtured the resentment of being enslaved by cigarettes … of being trapped and ever aware of the lingering panic. I believe these feelings impelled me to quit. I’d probably still be smoking if I were allowed to light up any time anywhere and not worry about what other people thought.

California is an example of just how effective well managed anti-tobacco programs can be. While cancer rates and deaths climbed everywhere else in the mid- and late 1990s, they declined in California. In 1990, California became the first state to implement a broad anti-smoking agenda. Consequently, cancer death rates fell nearly three percent a year from 1996 to 2005.

Is Chantix playing a role in these downward trends? It’s too early to tell. The drug has been on the market for just over 2 years, but already some studies show that the drug isn’t any more effective than the patch in helping people quit smoking for a year or longer. It will be interesting to track the success of Chantix and the impact it has, if any, on smoking and cancer rates in the years to come.

Sources: USA Today

SOURCE: Chantix Recall › the decline of smoking, cancer rates, and Chantix

Zug.com, a reader-powered comedy website, announced a contest it is holding for the most hilarious Chantix story. The person who submits the funniest account of his or her Chantix side effects will win $500.00 — enough money for another 5 months of prescriptions.

As bizarre as the contest sounds, Zug.com isn’t joking.

“We looked at all those side effects and we thought: pure comedy,” said ZUG.com editor-in-chief Sir John Hargrave in a statement. “In the bizarre dreams category alone, there’s just incredible humor potential for our site.”

A webpage for the contest, which runs through November 2008, asks, “Have you tried Chantix? Did you experience weird dreams, strange side effects, or violent mood swings? Write up your funniest description of the weird dreams or bizarre side effects of quitting smoking on Chantix, then submit them …”

It should be interesting to see how this contest is received by the public. Chantix was linked to more reports of adverse reactions and death than any other drug in the first two quarters of 2008. Controversy continues to escalate and broaden as the drug’s safety comes under close scrutiny by the Food and Drug Administration and is prohibited or banned outright by some government and professional organizations.

Irreverence is often a big part of comedy. The ability to laugh at one’s self is tantamount to (and nobler than) laughing at others. Still, though, it seems like there may be a line here that has been stepped on, if not crossed. Can Chantix reactions really provide fodder for the comedy mill? Are the side effects really a laughing matter?

SOURCE: Chantix Recall › Are Chantix reactions a laughing matter?

Thomas J. Moore, an independent researcher who analyzed the safety of Chantix for the FDA, told the Associated Press that he was particularly concerned about the non-psychiatric side effects Chantix has on some users. These effects include vision problems, disturbances of heart rhythm, seizures, skin reactions, aggression, and loss of consciousness, among others. In themselves, some of these side effects aren’t deadly. However, when they occur within the context of driving or operating heavy equipment, they may be very harmful, if not fatal.

A study of “adverse events” reports conducted by the Institute for Safe Medication Practices contained the following warning:

“We have immediate safety concerns about the use of [Chantix] among persons operating aircraft, trains, buses and other vehicles, or in other settings where a lapse in alertness or motor control could lead to massive, serious injury.”

In May, the Federal Aviation Administration (FAA) banned pilots and air traffic controllers from using Chantix. In August, the Federal Motor Carrier Safety Administration prohibited the use of Chantix without naming the drug specifically.

Late last year, Chantix claimed first place on a list of drugs with the most reported side-effect related problems. Traffic accidents ranked second in Chantix-related injuries, with 28 accidents directly attributed to use of the drug. Loss of consciousness, dizziness, confusion, and muscle spasms were the causes cited.

It’s important to keep these warnings in mind if you use Chantix and drive. Stay focused and alert; if you feel confused or dizzy, pull over immediately because the safety of you, your passengers, and everyone around you may be in jeopardy.

SOURCE: Chantix Recall › Chantix played role in traffic accidents

Now the FDA is paying closer attention to the potential psychiatric effects of non-psychiatric drugs. Anti-seizure medications, asthma drugs, and Chantix are some of the drugs now under watch for adverse psychiatric effects that they may have on the brain. This begs the question: Doesn’t every drug have the potential to affect the brain? Don’t medicines taken orally or by injection work by entering the bloodstream, which then delivers the drug to the target (in addition to the liver, kidneys, brain, etc.)?

According to an AP article, “Several independent experts say the safety alarms point to a gap in the FDA’s knowledge of how drugs affect the brain.” The article goes on to posit that “even if medications are intended for physical conditions, some drugs can have unforeseen consequences if they are able to enter the brain.”

I’m not a pharmacist or a physician, yet it still seems very elementary to me. First, don’t all drugs enter to the brain via the blood to some degree? And shouldn’t this little bit of knowledge be enough to prevent such gross oversights? The more one reads about the FDA, the more one realizes how much he has assumed about the scope of the agency’s knowledge and its effectiveness.

Until the FDA establishes an effective method for accurately quantifying rarer side effects such as depression and suicide, it is seeking a way of warning patients without alarming them or scaring them away from drugs that will likely help them. “Debunking false notions of risk is just as important to the public health as knowing about risks that exist” Kelly Postner, a researcher at Columbia University, who is working to develop a psychiatric screening system for people receiving trial drugs, told the AP.

Perhaps in the future we can expect a warning on all medications akin to the blanket warnings about peanuts and tree nuts found on food labels. The risks may be small for the vast majority of people, but no warnings can be exaggerated for the rare exceptions whose lives have been hurt or destroyed.

SOURCE: Chantix Recall › FDA broadens investigation of drugs and suicide

Heralded by many doctors and other experts as the most promising smoking cessation aid yet developed, for the unique way in which it blocked nicotine from reaching key receptors in the brain, Chantix was set to take over the stop-smoking world. The prevailing attitude seemed to be “it’s high tech, therefore it’s better.”

But is Chantix better? A study comparing the effectiveness of Chantix to NicoDerm CQ reveals that in the short term, yes, Chantix is better. In the long term, however, the same study indicates there is no difference. The study randomly administered either 12 weeks of Chantix or 10 weeks of the NicoDerm patch to 746 participants and followed their progress for a year. Chantix showed a higher rate of success over NicoDerm during the last 4 weeks of treatment. After a year, however, the rates of success were statistically the same.

While browsing the web for the latest news about Chantix, I come across a lot of emails, blog posts, and reader comments written by people who are taking Chantix or are considering taking it. It occurred to me today that this blog could serve as a forum for discussing smoking cessation methods and comparing them to Chantix. As a former user of Chantix, I actually have more than the FDA-recommended 12-week experience with the drug, but that’s another story and I’ll save it for another post!

SOURCE: Chantix Recall › Is Chantix better than nicotine replacement?

Chantix is known to create or worsen several neuropsychiatric conditions including suicidal thought and actions.

All of the 940 veterans in the VA study had been diagnosed with Post Traumatic Stress Disorder (PTSD). 143 of those veterans were selected to receive Chantix. Those veterans were given the drug and $30 monthly payments.

The FDA published its first Chantix warning on Nov. 20, 2007, with subsequent warnings from the FDA and the manufacturer Pfizer. Three months passed, however, before the VA notified all relevant doctors and staff involved in the study, and even then, there was no mention of suicide.

James Peake, Veterans Affairs Secretary, said that the 940 veterans in the study would receive a personal warning letter from him. Another 31,000 additional veterans would receive the same warning, he told The Washington Times.

Peake also disclosed that 26 of the study’s PTSD veterans experienced adverse events, including three reports of contemplated suicide.

The drug’s propensity to ignite suicidal thoughts and actions, especially in patients with heightened emotional and mental volatility, was the central concern of those calling for an end to the VA study.

While the VA does not intend to stop the study prematurely, it has said that it will end the study if necessary. New subjects are not being enrolled in the study.

SOURCE: Chantix Recall › VA warns veterans about the dangers of Chantix

Yesterday, Senators John Cornyn (R-TX) and Barack Obama (D-IL) rebuked the VA and demanded an investigation. Both the White House and VA officials dismissed the criticism, with White House deputy press secretary Tony Fratto calling the story an example of “irresponsible reporting.”

Today, however, more congressman are voicing their anger over the study, demanding answers, and calling for action.

Congressmen Bob Filner (D-CA), who is Chairman of the House Committee on Veteran Affairs, together with Rep. Ed Markey (D-MA), and Rep. Paul Hodes (D-NH) sent a letter to the Secretary of Veteran’s Affairs. In it, they voiced their alarm over the reported allegations and demanded copies of paperwork involved in the studies.

“Allowing, even encouraging, military veterans who have already made enormous sacrifices for our country to participate in drug studies that may cause serious, long-lasting health effects is tantamount to breaking our national promise to honor and support our veterans,” said Rep. Markey today.

The Congressmen sate in their letter, “When you’re taking advantage of a very vulnerable population, people who have served the country, and the agency that’s responsible for their welfare isn’t putting their welfare first, that’s a pretty serious breach of ethics.”

SOURCE: Chantix Recall › Outcry grows over VA Chantix tests

Today ABC reports that Senators Barack Obama (D-IL) and John Cornyn (R-TX) are demanding an investigation.

In the study, the VA gave 140 US soldiers with PTSD Chantix, not revealing to them that the drug had been linked to a number of physical and psychological side effects, including anxiety, nervousness, tension, depression, suicidal thoughts, attempted suicide, and actualized suicide. The Food and Drug Administration issued Chantix warnings months before the VA was compelled to notify the participating veterans.

Senator Cornyn told the VA Secretary to start asking questions and to take whatever measures are necessary to “identify the responsible parties, provide appropriate care to any veterans who have undergone this testing, and ensure that any unethical practices are immediately brought to a halt.”

Barack Obama made a public statement on the issue, saying “It is outrageous and unacceptable that our government would irresponsibly endanger veterans who have already sacrificed so much for our country.”

Despite the outcry, the White House wasn’t compelled to take action, finding apparently no fault in enlisting veterans with PTSD in a smoking cessation study and giving them a drug known for its potential to create a range of emotional and psychological havoc.

Deputy Press Secretary Tony Fratto dismissed the story as “irresponsible reporting,” claiming that the behavior of one soldier with PTSD taking Chantix was not concern enough to halt the entire study.

Barack Obama issued a statement on the matter today on his web site.

“Our veterans – particularly those suffering from mental health injuries – should have the very best health care and support in the world, they should never be needlessly exposed to drugs without proper notification of the dangers involved or effective monitoring of the side effects. I will immediately be asking for a full and thorough investigation of how our government could yet again let down our veterans and their families who have given so much to their country, and who have paid so much for the failures of civilian leadership in Washington,” said Senator Obama.

“It is time to demand accountability and to ensure that this kind of breach of trust never takes place again,” Obama said.

SOURCE: Chantix Recall › Senators Obama and Cornyn question VA over Chantix tests