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

When Thomas J. Moore analyzed data collected from the FDA’s Adverse Events Reporting System (AERS), he found nearly 600 reports of serious adverse reactions, including 150 suicides, were mixed in with 26,000 records of non-serious side effects such as nausea and skin irritations. These “missing” reports, some of which go back to 2006, also include accounts of uncharacteristic aggression and hostility, violent outbursts, severe nightmares, and debilitating depression.

In an interview with MSNBC, Mr. Moore said the situation represents “a major breakdown in safety surveillance.”

Chantix has long been blamed for causing severe psychosomatic distress in people who use the drug to ease the cravings for cigarettes while trying to quit smoking. Even before the additional reports of hostilities and suicides were discovered, Chantix has topped the list of the most dangerous FDA-approved drugs.

“It’s really chilling,” Moore added. “This seems to unleash something in people. It can be violence to anything around.”

Until July 2010, the FDA received 122 reports of suicide linked to Chantix, less than the number of suicides contained in the newly discovered reports. Mr. Moore also found the 589 concealed included 102 cases of hostility and aggression, 156 cases of depression, and 56 cases of possible psychosis.

Although Pfizer willfully included these reports with those of less serious side effects, technically the pharmaceutical giant wasn’t breaking the law. The FDA’s reporting system contains two channels through which adverse reactions are reported by drug companies. The “expedited” channel is for serious and unexpected injuries that drug makers must report within 15 days. The other “periodic” channel is for less-serious and expected adverse reactions, which drug companies must report quarterly.

Believe it or not, the FDA does not require companies to submit new reports of death and serious injury in the “expedited” channel for urgent review when such adverse events are already known to exist. This provision allowed Pfizer to include the suicides, suicide attempts, depression, and violent outbursts in with the less-serious, expected adverse events where they went overlooked.

The reported serious side effects were further obscured when Pfizer combined summaries and individual case reports into a s single text file instead of logging them into the AERS system individually, which dramatically reduced the occurrence of serious side effects linked to the drug.

Just as outrageously, the FDA seems to recognize the flaws in its reporting requirements, but isn’t in a rush to fix them. According to MSNBC, “FDA officials said they are considering changing regulations to allow expedited reports of suicides and other serious problems, even if they’ve previously been identified as expected. First proposed in 2003, that change is still pending.”

U.S. doctors prescribed Chantix 3.2 million times last year to smokers trying to kick the habit. The drug has been prescribed 1.1 million times so far this year.

Source:
http://www.msnbc.msn.com/id/43187290/ns/health-health_care/

SOURCE: Chantix Recall › Chantix suicides and violence much more common, newly found reports show

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

Data pulled from the FDA’s Adverse Event Reporting System (AERS) between October and December of 2008 suggested that Chantix may be linked to the side effects. The FDA will continue to monitor Chantix for an unspecified length of time until it determines what, if any, regulatory action is needed.

The FDA does not fully test prescription drugs for safety before allowing them to enter into the market. Why? It’s a matter of logistics more than anything. Typically, FDA studies are designed to measure a drug’s effectiveness using thousands of patients who willingly participate in pre-market clinical trials. These patients obviously represent a very small slice of U.S. population. The FDA also relies on studies conducted by the pharmaceutical companies themselves to determine how effective test drugs are. If new drugs that have passed tests for efficacy appear to be reasonably safe, then FDA researchers give them the green light.

The FDA, incidentally, reviewed Chantix in six months rather than the regular review time of 10 months.

The millions of people in the U.S. and around the world who started taking Chantix when it debuted on the world market in May 2006 became patients in the world’s first mass clinical trial. Most people assume that the FDA seal of approval means that the drug will be perfectly safe, but the truth is that most of a drug’s risks are not known until it is prescribed to millions of consumers.

The first reports of adverse events linked to Chantix emerged just months after the drug was released to the public. On February 1, 2008, the FDA issued a statement saying “it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms.”

By May 2008, Chantix was linked to more than 3,000 reports of serious side effects. By November of the same year, data from the FDA’s Adverse Event Reporting System showed that more reported serious injuries resulted from Chantix than any other prescription drug.

SOURCE: Chantix Recall › FDA monitoring Chantix for serious risks, new safety concerns

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

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 six-page letter alleges that FDA managers “have ordered, intimidated and coerced scientists to manipulate data in violation of the law,” according to a report in the Wall Street Journal.

“The scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk,” the letter states. Because of the corrupt conditions, the scientists say that the agency is “fundamentally broken” and as such is “failing to fulfill its mission.”

The scientists who penned the letter all work in the Center for Devices and Radiological Health,” a division of the FDA that “regulates items ranging from rubber gloves and contact lenses to heart stents and mammogram machines,” according to a report by CNN.

“There is an atmosphere at FDA in which the honest employee fears the dishonest employee,” according to the letter, which was addressed to President-elect Obama’s transition team leader, John Podesta.

The complaints of the scientists in the Devices and Radiological division iterate many of the same grievances raised by scientists from the FDA’s drug review division when Merck’s painkiller Vioxx came under fire in 2004.

“Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around,” the letter states. “Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal.”

Occasionally, scientists and doctors examining medical devices and equipment have been told during the approval process to ignore FDA regulations. The letter also charges that managers lacking the right level of knowledge and experience are authorized to push products through the approval process while ignoring concerns about safety and efficacy.

Top FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along,” the letter said.

The letter also charges that devices entering the market have been improperly labeled, and that manufacturers have been allowed to market their products without the FDA’s approval.

Internal investigations of these charges has amounted to “absolutely nothing,” according to the scientists. “No one was held accountable, no appropriate or effective actions have been taken, and the same managers who engaged in the wrongdoing remain in place and have been rewarded and promoted.”

In response to the accusations, FDA spokeswoman Judy Leon said “We have been working very closely with members of the transition team and any concerns or questions they have on any issue, we will address directly with the team. Separately, the agency is actively engaged in a process to explore the staff members’ concerns and take appropriate action.”

SOURCE: Chantix Recall › FDA scientists say their agency is corrupt and broken

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

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?

The dramatic increase of pharmaceutical drug related injuries occurred in the first three months of 2008, during which time 20,745 serious side effects and more than 4,800 deaths were reported. The incidents represent a 38 percent rise over the previous four quarters and constitute the single highest spike yet recorded.

Prescription drug related death historically accounts for 16 percent of all serious cases reported. That number soared to 23 percent in the first quarter of 2008.

According to the FDA standards, a serious drug reaction is one that leads to medical intervention or hospitalization and jeopardizes the life of the user. AERS data comes from reports that are voluntarily submitted by medical professionals. The data is generally regarded as a small representation of a much larger picture.

According to ISMP, “Some of the increases in quarterly totals could represent normal variation in the flow of reports rather than signaling a long-term trend in patient safety. However, the data are compelling and should serve as one source of information regarding drug safety in the US.”

More reported serious injuries result from Chantix usage than any other prescription drug. Chantix accounted for 1,001 new cases of serious injury, including 50 deaths.

Pfizer refuted the FDA data and ISMP’s interpretation of it. “Based on [the] totality of data, we stand by the efficacy and safety profile of Chantix when used as directed,” said Pfizer spokeswoman Kristen Neese in a statement.

SOURCE: Chantix Recall › Chantix plays role in record number of drug reactions

More than 1,000 complications were reported in the first quarter of 2008, including 15 traffic accidents, 52 incidents of loss of consciousness and blackouts, and 50 deaths.

Reports of adverse effects among users taking Chantix were greater than any other prescription drug for the second quarter in a row.

While the drug already urges caution while driving and operating machinery, the new reports suggest a stronger warning may be justified. The Food and Drug Administration is currently reviewing the data to determine if Chantix should carry warnings against driving and operating machinery altogether.

“FDA confirms that there are reports of accidents, including road traffic accidents, after the use of varenicline in the Adverse Event Reporting System. The FDA is reviewing these reports to see if current labeling related to accidents after varenicline is adequate,” said FDA spokesman Christopher DiFrancesco in an email to Reuters.

Earlier this year, the Federal Aviation Administration banned pilots and air traffic controllers from using Chantix. The Federal Motor Carrier Safety Administration also prohibited the use of Chantix.

“It appears that medical examiners should not certify a driver taking Chantix because the medication may adversely affect the driver’s ability to safely operate a commercial motor vehicle,” FMCSA Administrator John H. Hill said in a public statement.

Chantix sales in the U.S. declined more than a third following warnings about dangerous side effects and a subsequent suspension of Pfizer’s advertising campaign. Sales outside of the U.S. rose by 3 percent.

Chantix plays a key role in Pfizer’s financial pipeline as its other blockbuster drug Lipitor will go generic after July 2010.

SOURCE: Chantix Recall › Researchers recommend new Chantix warnings

According to an article in Forbes magazine, Chantix is in line to become Pfizer’s vital cash cow as patent protection for some of the company’s successful older medications expires. Patent Protection for Lipitor, currently Pfizer’s top seller, expired in Canada last year. Remaining patents will expire in 2011.

As reports of Chantix-linked depression, strange behavior, and suicides emerged late last year, the Food and Drug Administration issued an alert stating that it was investigating the reported side effects. Two months later, when the FDA required that the potential side effects be printed on the drug’s label, Pfizer ceased advertising the drug by name.

“By name” being the key words. Considering the importance of Chantix to Pfizer’s overall financial health, Pfizer couldn’t-didn’t-wouldn’t stop the advertising altogether. If you’ve seen the television spot for mytimetoquit.com, you’ve seen a Chantix ad, albeit one that looks more like a public service commercial.

One version of the ad features a mélange of smokers talking about why smoking was so hard for them to quit. The most recent ad features an individual woman who says “At 6:30 in the morning I have a cigarette. And then another on my way to work,” and so on.

This is a form of advertising that the pharmaceutical companies are turning to more and more because it’s such a deft way of drawing attention to the product without having to identify the product specifically and therefore mention any safety information. Viewers simply go to the website, where they will find a lot of information about how difficult it is to quit smoking, along with a link to the Chantix website.

SOURCE: Chantix Recall › Chantix ads back on television

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

According to the news organizations, the Veterans Administration chose to administer Chantix to 140 Iraq and Afghanistan veterans who have been diagnosed with Post Traumatic Stress Disorder (PTSD), ignoring Food and Drug Administration warnings that the drug has been linked to vivid dreams, psychiatric illnesses, and suicide, to name just a handful of the drug’s potential adverse effects.

The VA waited more than three months before it began notifying the veterans of the dangers of Chantix. Even then, the attitude was rather flip. Dr. Miles McFall, one of the VA study’s administrators, told ABC news that the drug warnings “didn’t justify an emergency warning at that level.” Dr. McFall said this even after one of the study’s subjects suffered from a severe mental collapse after he began taking Chantix.

38-year-old James Elliot, a US Army sniper, snapped one night and left his house with a loaded gun. His fiancée called police, warning them that Elliot was a soldier with PTSD and had left the house in a mentally unstable condition. Police Tasered Elliot and placed him under arrest that night.

When Elliot learned that the VA had withheld the Chantix warnings from him and others in the study, he told ABC news that he felt like a “Lab rat, guinea pig, disposable hero.”

The VA notified the soldiers taking Chantix three weeks after Elliot’s incident. In its letter to the PTSD veterans, the VA stated that Chantix had been linked to adverse side effects, including “anxiety, nervousness, tension, depression, thoughts of suicide, and attempted and completed suicide.”

The Chantix study is just one in 25 studies that the VA is conducting on our veterans. It’s understandable that the side effects of new drugs do not become fully known for months or even years after their debut on the market. However, withholding known drug warnings, especially from veterans with PTSD, is unconscionable.

Arthur Caplan, director for Bioethics at the University of Pennsylvania and one of the country’s top medical ethicists, expressed his feelings about this case to ABC News. “How this study continued in the face of these difficulties is almost impossible to understand … Why take the group most a risk and keep them going? That doesn’t make any sense, once you know the risk is there,” he said.

SOURCE: Chantix Recall › VA testing Chantix on veterans with Post Traumatic Stress