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

“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

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

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

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

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

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

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

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

Now the 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

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

“Those in the VA who failed to properly notify America’s veterans that their medication could produce fatal side effects must resign their positions,” Lisicki said. “If not, then the VA secretary must take decisive action to terminate their employment.”

Lisicki issued the off-with-their-heads statement in response to reports (link) that the VA may have acted irresponsibly in its study of Chantix using veterans with Post Traumatic Stress Disorder (PTSD).

The VA originally said that 940 veterans with PTSD were enrolled in the study, but only 143 of them were receiving Chantix. (link) However, The Washington Times revealed the number of PTSD veterans receiving Chantix was actually 68 percent higher than the VA originally acknowledged: 241, as opposed to 143.

Of the 241 test subjects, there were 114 reported adverse effects, including 22 psychiatric events.

The VA also prescribed Chantix to some 32,000 other veterans. From that group, 27 were admitted to VA hospitals for apparent psychiatric disorders. Among those, 11 had attempted suicide, 9 had suicidal thoughts, six suffered from hallucinations, and 1 attempted homicide.

Last month, ABC News and The Washington Times revealed (link) the VA’s failure to notify the study’s veterans about the potential psychiatric hazards of Chantix until three months after the FDA’s initial warnings.

Secretary of Veterans Affairs James B. Peake, M.D. insists that the VA has nothing but the veterans’ best interests in mind in determining courses of treatment. After the joint ABC News / Washington Times broke, allegations emerged implying that big pharmaceutical companies and universities may be funding and compromising VA research and care. Dr. Peake called the allegations “ridiculous.”

Still, Dr. Peake has ordered four internal investigations of the Chantix study and the VA’s general operations, ostensibly to safeguard against repeating similar blunders in the future.

To Lisicki and many veterans, the VA’s neglect in informing PTSD veterans about the dangers of Chantix, followed by the administration’s unapologetic attitude, is inexcusable.

“Professional ethics and common sense just dictate that clinicians would stop their patients from taking the drug just to err on the side of safety for the veterans and their families,” Lisicki said.

If the VA tests Chantix on veterans with PTSD, then how would it be able to determine if the emotional and behavioral problems are caused by the drug or the psychological trauma? Wouldn’t being able to differentiate between two possible causes determine the best course of treatment?

Aren’t our veterans worthy of an administration that treats them with genuine care and, perhaps above all, compassion?

SOURCE: Chantix Recall › More veterans enrolled in Chantix study than originally revealed

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

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

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

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

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

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

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

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

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

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

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

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

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

SOURCE: Chantix Recall › Outcry grows over VA Chantix tests

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

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

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

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

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

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

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

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

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

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

Factoring into the decision was the fact that Smith did not have any prior record of criminal activity or psychiatric disorders, the AP report says.

This incident is the latest in a crop of reports that Chantix is responsible for serious psychiatric problems, including depression, suicidal thoughts, suicide, and aggressive behavior. On Feb. 1, the FDA issued a public advisory about the possibility for these adverse serious side effects.

SOURCE: Chantix Recall › Charge dropped due to Chantix use

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