Evidence is accumulating that the stop-smoking treatment Chantix is linked with unprovoked acts and thoughts of aggression and violence, consistent to a new report.

The treatment is so potentially hazardous that its use should be restricted to
exclude police, military, and similar occupations in which workers carry
weapons, says Thomas J. Moore, senior scientist for treatment protectedty and policy at the Institute for protected drug Practices in Horsham, Pa. Moore is one of three co-authors of the new report on the treatment,  published in the Annals of Pharmacotherapy.

“My colleagues and I have been concerned about the protectedty profile of
[Chantix] since our first report [warning of adverse events] in 2008,” Moore
tells WebMD.

But others, including a smoking cessation researcher and a spokesperson for
Pfizer, which makes Chantix, disagreed strongly. They point out that the number of adverse events is far outweighed by the benefits of the treatment, which has helped countless people give up cigarettes and the health risks associated with tobacco use.

One co-author of the report, Joseph Glenmullen, MD, of Harvard Medical
School, has been retained as a potential askant in legal cases involving
Chantix. He frequently provides expert testimony on the side effects of psychiatric drugs.

About Chantix

Chantix was approved by the FDA in May 2006 as a smoking cessation treatment.
It targets nicotine receptors in the brain, blocking nicotine from getting to
them.

Smokers begin at a low dose and then increase it, continuing to smoke until
the eighth day, when they are instructed to quit. They continue the treatment for 12 weeks and in some cases an extra 12.

In late 2007, concern surfaced after an episode in which a Dallas musician
taking the treatment displayed aggressive, abusive behavior and was shot dead while trying to kick in the door of a girlfriend’s neighbor, the researchers write.

Since the treatment came on the market, the FDA has received adverse event reports and then issued communication about the probable risks, and required a drug guide be given to each patient and with each refill. On the package insert, a boxed warning say s that some people have had changes in behavior as well as hostility, agitation, suicidal thoughts, and other predicaments. Patients are advised to stop the treatment and get medical help if that occurs.

Chantix: A Closer Look

Moore and his colleagues gathered information on 78 adverse event reports
received by the FDA as well as four other cases reported in hospitalal trials and three others from published literature. Moore suspects that the 78 cases are just a fraction of existing reports and that some adverse events are unreported.

The researchers used assessment tools to home in on 26 of the cases to look
at more closely. Of these 26:

• 10 involved assault
• 9 involved homicidal thoughts
• 7 cases included other thoughts or acts of aggression or violence

In a sampling of the cases, the researchers reported that:

• A 24-year-old woman on the treatment woke up her boyfriend and started beating
  him, then attempted to kill herself.
• A 21-year-old woman threatened her mother with a shotgun.
• A 46-year-old man reported he had ”crazy thoughts” of killing himself and
  his parents.
• A 42-year-old man punched a stranger while at a bowling alley.

The symptoms usually began soon after starting the treatment, Moore and his colleagues say, occurring a median of two days after starting.

They found that when the treatment was stopped, the symptoms and other adverse effects resolved in most all cases.

Moore and his colleague note that ntimely 40% of patients on Chantix were as well on tranquilizers, antidepressants, or antipsychotic treatments, consistent to the FDA.
The adverse events, the researchers write, may be more or less likely when
another drug is as well being taken.

The acts are not likely part of nicotine withdrawal, the researchers say, as
they say the effects aren’t noticed in other smoking cessation products. The
predicaments may be confined to a small, susceptible group, they say.

Chantix: Other Views

The new report shouldn’t turn people automatically against the treatment, says Serena Tonstad, MD, PhD, a professor of health promotion and education at the Loma Linda University School of Public Health in Loma Linda, Calif., who reviewed the report for WebMD.

She has served on the advisory board and has been a askant for Pfizer.

”I wouldn’t advise people not to try it [Chantix] based on this report,” she
says. “The benefit of quitting smoking is most essential.” And, she says, the
treatment has proven effective in helping people to quit.

She does agree that people on the treatment need to be monitored, and people with bipolar disorder should be especially closely monitored, she says. In her experience, they seem to be more at risk for complexies than people with other psychiatric predicaments. ”With depressed people, I like their depression to be controlled before putting them on smoking cessation,” she says.

MacKay Jimeson, a spokesman for Pfizer, issued this conditionment: Pfizer takes the protectedty of all of its treatments severely. All post-marketing reports of adverse events are reviewed by Pfizer, and reported to regulators, including FDA. The currently approved Chantix label contains a boxed warning regarding
reports of serious neuropsychiatric events reported in some patients. If these
neuropsychiatric symptoms are observed by the physician, patient or caregiver,
patients should stop taking Chantix and inform their healthcare provider
immediately. There is no reliable scientific evidence demonstrating that Chantix causes these events.”

Hospitalal studies are under way, he says, “to help us further characterize the
benefit risk profile of Chantix in different smokers. As studies complete, the
results will be published.

From May, 2006 until late last year, Jimeson says, more than 12 million
prescriptions for Chantix had been written worldwide. More than 6 million in the U.S. have been prescribed the treatment, consistent to the treatment’s web site.

SOURCES:
MacKay Jimeson, spokesman, Pfizer Inc.
Serena Tonstad, PhD, MD, professor of health promotion and education, Loma Linda University School of Public Health, Loma Linda, Calif.; askant and advisory board member, Pfizer Inc.
Thomas J. Moore, senior scientist, treatment protectedty and policy, Institute for protected
drug Practices.
Moore, T. The Annals of Pharmacotherapy, online July 20, 2010.

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The number of people willing to quit smoking is increasing, so is the number of medicines increasing available in different forms and brands. Now, the smoker just needs to know his level of addiction, consult a doctor for the recommendation of his dosage, and he can start his routine to quit smoking.

There is a variety of quit smoking medicines available, better known as nicotine replacement aids, in the form of gums, patches, inhalers, vaporizers, injection, lozenges, and many others which could be opted by the smoker according to his suitability. Though it is very difficult in the initial stage to sustain the usage of any aid, as the craving may pull him back to his addiction, once the smoker reaches a certain level, it may give him the drive to continue it. He could try few aids and brands to get the one which would suit him the best.

Another form of quit smoking medicine is Buproprion (Zyban) which was originally made as an anti depressant, but its usage among the patients automatically brought in the effect of reducing the desire to smoke. This medicine is a discovery on its own, but is available on prescription only, and has some side effects associated as any other medicine. Thus it should be followed only by a doctors recommendation.

The quit smoking medicines helps the smoker get away from his habit, and if not totally, then at least it helps him reduce the level of intake. The side effects, such as headaches, nausea, dizziness, and others need to be tolerated in the initial stage to get improvement; as the constant use of the medicines will gradually reduce the side effects.

Despite all kinds of medicines available, the best way to quit smoking would be if a smoker could get away from this habit on his own that is by means of his own determination, dedication, and will power which would never have any side effects.

Champix 0.5 mg 56 tabl.

Champix tablets contain the active ingredient varenicline, which is a medicine used to help people who are addicted to nicotine to give up smoking. It acts in the brain, but is not the same as nicotine replacement therapy. Champix (varenicline) is a type of medicine called a nicotinic acetylcholine receptor partial agonist.

Contrary to information that led the FDA and other regulatory agencies to release warnings about varenicline (Chantix), a new study has found “no clear evidence” of a relationship between the risk of suicide and the stop smoking drug.

Both varenicline(Chantix) and bupropion (Zyban), another stop smoking drug, were associated with a 12% and 17% increased risk, respectively, of self-harm compared with people who used a nicotine replacement product, but the confidence intervals were wide and straddled 1.00, David Gunnell, PhD, of the University of Bristol in the U.K., and colleagues reported online in British Medical Journal.

The limited study power “means we cannot rule out either a halving or a twofold increase in risk,” the researchers said.

Adverse event reports have sparked growing concern that Varenicline may be associated with an increased risk of suicide.
Regulatory agencies worldwide have issued warnings on use of the drug, and last July, the FDA required boxed warnings on both varenicline and bupropion.
However, the researchers said, few large population studies have been done to assess the risk. Further, they said, assessing risk is challenging because of the need to control for confounders such as previous disease and smoking habits.
People who smoke already have a two- to- threefold increased risk of suicide, since smoking is common among people with psychiatric illness, they said. Also, it’s possible that [smoking] “has a beneficial effect on psychiatric symptoms, such as anxiety, that may be lost with smoking cessation,” the researchers added.

And last March, a study in the Journal of General Internal Medicine found that varenicline didn’t increase the risk of depressive symptoms.

So to clarify the issue, the researchers conducted a cohort study of 80,660 patients ages 18 to 95 who were prescribed a new course of any quit smoking medications — nicotine replacement products, bupropion, or varenicline — between Sept. 1, 2006 and May 31, 2008.

In general, patients prescribed bupropion or varenicline were less likely than those on nicotine products to have a history of psychiatric consultation, alcohol misuse, use of psychotropic medication, or self harm or suicidal thoughts.
There were 166 episodes of nonfatal self-harm, two suicides – both in the nicotine replacement group – and 37 episodes of suicidal thoughts.
The incidence of self-harm was 533.1 per 100,000 person-years in patients on varenicline, 498.7 for those on bupropion, and 751.7 for nicotine replacement products.

The researchers found “no clear evidence” that varenicline was associated with an increased risk of suicide or nonfatal self-harm. However, they said they could not rule out a twofold increased risk “on the basis of the upper limit of the 95% confidence interval.”
Those confidence limits were 0.67 to 1.88 for varenicline and 0.59 to 2.32 for bupropion.
Varenicline was also associated with a 43% increased risk of suicidal thoughts compared with nicotine replacement products, but, again, the confidence intervals were wide and straddled 1.00 (95% CI 0.53 to 2.85).

The researchers said such evidence is consistent with all possibilities – “a large protective effect, no effect, or a large adverse effect.”

Yet they cautioned that suicidal thoughts are under-recorded in the General Practice Research Database, from which they took their data.

The study may also have been limited in its power, since there were only 18 episodes of self-harm reported in the varenicline group, the researchers said.

Still, they concluded, in light of the “possible increased risk of suicide associated with these stop smoking drugs and their increasing popularity, further investigation of their effect on suicide risk is required in other databases and through secondary analysis of all adverse events reporting in relevant clinical trials.”

Zyban 150 mg 30 tabl.

Champix 1 mg 28 tabl.

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Champix 1 mg 28 tabl.

How does Chantix work

Chantix (or Varenicline) belongs to the class of medications called smoking cessation therapies. It is used to help people quit smoking.
Chantix is intended to be used by adults in combination with quit-smoking education and counselling.  It effects on the brain to reduce cravings and nicotine withdrawal symptoms. This quitting drug decreases the pleasure that people get from smoking. It is thought to have these effects by working at the same receptors that nicotine from cigarettes affects, although exactly how varenicline works is not clear.
Chantix also blocks the way nicotine acts on these receptors.

This means that if the patient who is trying to quit smoking makes a mistake and has a cigarette, there will be no satisfaction or enjoyable effects from that cigarette.

This makes smoking highly unappealing, and helps a patient reduce nicotine withdrawal symptoms and break smoking habit much faster.

Chantix side effects

Both the European Medicines Agency and the FDA have approved this product for use as a stop smoking medication. Even with this approval, it is important for smokers to realize that Chantix does have some potential drawbacks.

First, if the drug is not taken as prescribed and for the entire treatment period, the desire to smoke will often return. The minimum treatment period is 12 weeks. However, permanent results are more prevalent among those patients who use the product for 24 weeks.

Another potential drawback of taking Chantix is the fact that there are some side effects that can occur. The most common side effect is mild nausea, which usually goes away after the treatment begins. Other mild side effects, such as appetite changes, dry mouth, tiredness, and headache, rarely prevented patients from finishing the treatment.

However, some patients experienced severe mood swings, depression, or serious sleeping problems. These more serious side effects did cause some patients to stop taking the medication.

Before taking the quit smoking medication tell your doctor if you are pregnant, plan to become pregnant, or if you take insulin, asthma medicines, or blood thinners.

Champix 1 mg 28 tabl.

Through further testing, the drug was found to be effective in treating the smoking addiction, and helping smokers quit. GlaxoSmithKline “repackaged” Wellbutrin and marketed it as the Stop smoking drug Zyban.
Unlike nicotine patches or nicotine gum, this Stop smoking drug does not put more nicotine into your body.

It’s supposed that you should stop smoking if you use the quit smoking patches or gum. With Zyban, you continue to smoke when you first start taking the medication, eventually reduce craving to cigarettes. You also should also take the drug Zyban for a period of time after quitting.

How Zyban works

Zyban does not provide nicotine to the body; it makes the smoker a feeling of well-being that allows him to give up the smoking habit with relatively little difficulty.

Stop smoking drug Zyban makes quitting easier. According to the clinical trial researches treatment with ZYBAN reduced nicotine withdrawal symptoms compared to placebo. Zyban has Bupropion that works more like an antidepressant. Bupropion is a relatively weak inhibitor of neuronal intake of dopamine, serotonin or noreoinephrine.

It works by boosting the levels of several chemical messengers in the brain. With more of these chemicals at work, you experience reductions on the following nicotine withdrawal symptoms: irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; and depressed mood or negative affect.

Do note that Zyban has known side effects which include body pains and insomnia and is contradicted with some other medications. People with a history of seizures, eating disorders, or cirrhosis of the liver should not this stop smoking drug Zyban.

Zyban 150 mg 30 tabl.

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