The FDA issued a new Chantix warning in June, alerting health care professionals and patients to the results of a new randomized, double-blind clinical trial of 700 smokers who were given either Chantix or a placebo. All of the participants had been diagnosed previously with heart disease. After 12 weeks on Chantix, researchers found that more than twice as many Chantix patients suffered heart-related problems than the placebo patients.

The events included angina pectoris, nonfatal myocardial infarction, the need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease. Seven out of 353 Chantix patients had a nonfatal heart attack, versus 3 out of 350 of the placebo patients.

The new label warning also includes information about the potential effects of Chantix on COPD patients. This information is based on findings from a clinical trial of 460 patients with mild to moderate COPD who were randomly given either Chantix or placebo for 12 weeks and then monitored for 40 weeks.

According to the FDA, the adverse events reported in this trial underscored some of those that were found in studies conducted for Chantix’s initial approval in 2006, but no new concerns were identified.

It should be noted that the new required warnings do not reflect the results of a larger, more recent study that monitored the cardiovascular health of 8,000 Chantix patients in a series of 14 smaller clinical trials. The New York Times reported the results of this study, which was published in the Canadian Medical Association Journal. It revealed 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.

In the real world, this means 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.

Despite the new warnings and mounting evidence that the dangers of Chantix have been greatly understated, the FDA continues to allow the drug a place on the market. According to the agency, “Smoking is an independent and major risk factor for cardiovascular disease, and smoking cessation is of particular importance in this patient population. The known benefits of Chantix should be weighed against its potential risks when deciding to use the drug in smokers with cardiovascular disease.”

Additional sources:

http://www.ismp.org/quarterwatch/2010Q2.pdf

http://www.medpagetoday.com/PrimaryCare/Smoking/27711

SOURCE: Chantix Recall › FDA expands Chantix warnings to include increased heart risks

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

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

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?