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

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?

“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

Such a finding would steer attention away from the host of negative side effects that Chantix is known to have. Moodiness, erratic or unpredictable behavior, depression, blackouts, memory loss, confusion, and suicidal thoughts and actions are some of the psychiatric side effects reported by many Chantix users. Non-psychiatric reactions such as sleeplessness and nausea are just as prevalent.

Soon after news of Chantix’s dark side emerged, the drug seemed to enter a tailspin. Pfizer yanked its commercials from the airwaves, numbers from the Institute of Safe Medicine Practices and the FDA revealed it to be one of the most dangerous drugs on the market, and sales and revenues plummeted.

Now that sales have steadied, the time is right for Pfizer to give its lackluster blockbuster a boost. According to CNN, “a study that demonstrates Chantix helps prevent heart attacks could mitigate the safety issues and revive sales, though there is the risk that a negative result would further damage sales.”

According to the CNN report, the study would examine whether Chantix reduces “the risk of subsequent heart attacks in smokers who have already had one.”

However, people who stop smoking, whether they use Chantix or some other smoking-cessation aid, will have already reduced their risk of heart attack simply by quitting smoking, so such studies would seem redundant.

But there you have it. If suicidal tendencies were considered a positive benefit of Chantix, you can bet Pfizer would be spending millions on finding more about that link.

According to the CNN report, Pfizer will decide whether to fund such a study by the end of the year.

SOURCE: Chantix Recall › Pfizer might fund study of Chantix and reduced risk of heart attack

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

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

If Rep. Henry Waxman (D-Cal.) has his way, such ads will be a thing of the past, unless the advertised drug has proven to be safe over time. Waxman has renewed the push to give regulators the power to ban direct-to-consumer (DTC) advertising for new prescription drugs when their safety profiles aren’t fully known. The would-be legislation, which emerged in 2007 but ultimately failed to pass, is plowing ahead in the wake of some heavily promoted but beleaguered blockbuster drugs.

Chantix, along with other new “blockbuster” drugs such as Vioxx and Vytorin, were more or less indicted after tests and reports brought unknown risks to light, and all of them made billions in profit before negative news rained on their parade.

Rep. Waxman, who becomes chairman of the House of Representatives Energy and Commerce Committee when the new Congress convenes in January, has expressed his interest in revisiting the drug ad issue.

“It is these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a Prescription Project conference.

Merck’s blockbuster anti-inflammatory drug Vioxx was taken by approximately 20 million people before its risk of cardiac events became known. Likewise, millions of people took Vytorin before one test exposed it as a dud and another a possible cancer risk. And still millions more took Chantix before researchers understood the risks the drug posed for depression, suicide, and other serious side effects. Chantix now tops the list of the most dangerous drugs available in the U.S.

To help ease the dangers posed by new medicines, Congress sought last year to give the FDA the authority to ban the television advertising of new prescription drugs for as long as three years if it was deemed necessary to protect the public. The ban would not be a blanket ban on all new prescription drugs, but would be enacted on a case by case basis.

Exaggerated benefits and minimized perception of side effects are two pitfalls of DTC advertising for the general public. Excessive prescribing is another, but that seems to be the whole point, at least from the drug manufacturers’ point of view. Television ads for new prescriptions aren’t made with the public’s good in mind. They’re made to maximize profit. Advertising for profit is the American way, but when it amounts to messing with the health of millions, clearly some restraint is needed.

According to a report by Reuters, drug makers claim that their ads are informative to the general public. They say they have adopted voluntary guidelines which make them refrain from advertising for “an appropriate amount of time” so that doctors can be informed of the new drugs first.

An example of such restraint is Merck’s marketing of the diabetes drug Januvia.

According to Reuters, “the product Web site was functional within 90 minutes of approval, and within eight days, Merck had reached 70 percent of target doctors and made first deliveries of [Januvia] to pharmacies. Within 14 days, discussions were completed with managed care organizations covering around 188 million patients or 73 percent of the insured U.S. population.”

Whatever restraint is exercised, no time is wasted in infiltrating the market.

The 2007 attempt to reign in advertising for new drugs failed after some lawmakers objected it would violate constitutionally protected free speech. Congress instead granted the FDA authority to fine drug companies for false or misleading advertising.

SOURCE: Chantix Recall › Will those long Chantix commercials disappear again?

Chantix became available in the UK in December of 2006. Since then, nearly 400,000 prescriptions for the drug have been written.

Karen McGhee, a resident of Greenock on Scotland’s western shore, was one of those Chantix users. McGhee had been taking Chantix only a few days when she attempted to kill herself.

The McGhee’s daughter found Karen and ran to get her father’s help, shouting that her mother had hung herself.

“I just got woken up with my daughter dragging me out of my bed to come downstairs,” Karen McGhee’s husband, Robert, said.

He found his wife hanging from the stairs in the hall of their home.

“I ran downstairs and Karen was on the floor on her knees with a pelmet round her neck. I tried to lift her up to free the knot, but I couldn’t get it loosened. I managed to cut her free and take the noose off her neck,” he told the BBC.

“I just couldn’t comprehend it. I thought I was dreaming.”

Karen McGhee spent several days in the hospital hooked up to a ventilator before finally recovering from the incident.

She vowed to avoid Chantix in the future. “I’ll never put myself through that again and never put my family through it again. I’ll always be a smoker, or, if I quit, then I’ll quit naturally,” she told the BBC.

Another Chantix-related incident occurred in the city of Manchester in northern England. Omer Jama, who the BBC describes as a “young Manchester man,” slashed his wrists. His brother Ali called the incident “a random act, completely out of character, that took an instant.”

Omer Jama did not survive the incident. He did not leave a suicide note and his death was not recorded by the coroner as a suicide.

According to Ali Jama, the coroner recorded Omer’s death with an open verdict rather than issuing the verdict of suicide because forensics revealed Omer had Chantix in his blood at the time of his suicide.

The coroner researched the toxicology results and learned of the possible links between Chantix and suicidal behavior.

More than 3,000 people have reported adverse reactions to Chantix across Britain. 260 of those reactions have been classified as suicidal in nature. 16 Chantix users attempted suicide and 10 killed themselves, the BBC reports.

SOURCE: Chantix Recall › BBC investigates Chantix suicides in the UK

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

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

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

Chantix, manufactured by Pfizer, was approved in 2006 and since that time has been prescribed to more than 4 million patients. However, not long after its release, the drug was linked to psychiatric problems including depression, suicidal thoughts and actions, and aggressive behavior. The drug also has been linked to serious physical side effects including heart problems, diabetes and serious allergic reactions such as Stevens Johnson Syndrome.

According to the Stars & Stripes, the drug was removed from the military pharmacy at Yokota Air Base in Japan. The decision came after a May 21 report by the Institute for Safe Medication Practices, which says Chantix has had more serious adverse incident reports in the fourth quarter of 2008 than any other drug in this time period.

In response to the ISMP report, the Federal Aviation Administration banned pilots and air traffic controllers from using the drug. The Stars & Stripes reports that the Defense Department’s Office of the Chief Medical Officer also recommended that “varenicline should not be used by personnel operating aircraft (including aircrew and air traffic controllers) and missile crew members.”

The paper says the DOD safety notice also had recommendations for “vehicle operators, operational personnel, and other DOD personnel” under consideration.

Stars & Stripes says the Yokota base has not reported any adverse reactions to Chantix, but seems to be banning the drug as a precautionary measure, and has suspended refills of Chantix until patients review the drug use with their physician. Other base hospitals overseas have not banned the drug, but air crewmembers cannot take the drug, and other Chantix patients are required to discuss their use of the product with their physician. Pharmacies can special-order the drug based on those prescriptions.

According to the report, when Chantix was first licensed in 2006, it was prescribed 262 times in military treatment facilities. By fiscal year 2007, there were 67,580 prescriptions written for Chantix in military facilities.

SOURCE: Chantix Recall › Military pharmacy pulls Chantix

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

As a result of its study, the ISMP is recommending the FDA strengthen warnings on the drug, which has been prescribed to more than 3 million people since it was approved in May 2006. Also as a result of the report, the Federal Aviation Administration banned use of Chantix by pilots and air traffic controllers.

The Bloomberg story cites FDA spokesperson Susan Cruzan as saying the ISMP study will prompt the FDA to conduct immediate further research to confirm numbers. Because the FDA’s adverse event reporting system is voluntary, she is cited as saying, there are no controls in place to determine if the reported side effects are the result of Chantix use, or if they are coming from another drug that reporters may be using.

SOURCE: Chantix Recall › More than 3,000 side effect reports

As a result of these reports, the FDA issued a public advisory, and required new safety warnings on the label. However, the FDA said it is still not sure if the side effects are attributable to Chantix, or may stem from nicotine withdrawal itself, which may worsen underlying existing psychiatric symptoms.

The Star-Ledger report says the FDA was spurred to more closely examine Chantix after a case in Dallas, Texas, involving musician Carter Albrecht, who was fatally shot after a night of “uncharacteristically violent behavior,” which his family attributed to his Chantix use.

According to the Star-Ledger, Pfizer said there were no suicides attributed to the drug during clinical trials, and they did not note any differences in behavior in clinical test subjects. However, the company also says that no people with known existing psychiatric disorders were used in the trials.

The drug is currently undergoing further study.

SOURCE: Chantix Recall › Dark side of Chantix comes to light