Cigarette smoking damages practically every organ in the human body and causes an overwhelming number of deadly diseases, from lung cancer and chronic obstructive pulmonary disease to heart attack and stroke. Medications play a limited role in helping smokers overcome nicotine dependency. Varenicline (CHANTIX) is one such medication. Approved by the Food and Drug Administration (FDA), the drug reduces the symptoms of nicotine withdrawal by blocking nicotine from binding to the brain receptors that are involved in reinforcing the effects of nicotine dependency. The drug is available as oral tablets, which are taken twice a day for 12 weeks and can be continued for an additional 12 weeks. With almost millard in sales, the drug is one of the top 3 most prescribed quit smoking drugs in the U.S.
Product containing varenicline: varenicline systemic. Brand names: Chantix, Champix. Varenicline is effective in helping many people quit smoking. However, it is associated with serious adverse effects, including neuropsychiatric symptoms (such as depression) and cardiovascular disease (including abnormal heart rhythm). The benefit harm balance of varenicline is less favorable than nicotine replacement therapies, which were first approved many years ago and are available in various forms, including in gum, inhaled and skin patch versions. Therefore FDA has classified varenicline as a drug of last resort: It should not be used unless all other methods of smoking cessation have failed. Ask your health care provider the following questions:
When you smoke, nicotine is sent to your brain, where it attaches to nicotine receptors. A chemical called dopamine is released, making you feel good. Then your dopamine levels drop. This makes you want another cigarette. CHANTIX attaches to nicotine receptors in the brain, so that nicotine can’t. With CHANTIX, dopamine is still released, but less so than with nicotine. It is believed that these actions are how CHANTIX may help you quit smoking.
Varenicline's approval was supported by six clinical trials that enrolled a total of nearly 3,700 chronic smokers who were treated with varenicline, bupropion (ZYBAN) — another oral smoking cessation drug that contains the same active ingredient found in the antidepressant drug WELLBUTRIN — or a placebo. In these trials, 40 to 51 percent of varenicline-treated subjects were tobacco-abstinent after three months of therapy, whereas 30 percent of bupropion-treated subjects and 12 to 18 percent of placebo-treated subjects were tobacco-abstinent. However, only 19 to 23 percent of vareniclinetreated subjects, 14 to 16 percent of bupropion-treated subjects and 4 to 10 percent of placebo-treated subjects were tobacco-abstinent nine months after therapy ended, indicating a high rate of smoking relapse. The smoking cessation rates achieved in these trials, which appear to have been conducted in academic centers or specialist clinics, may not translate to routine primary practice for two reasons. First, these trials provided smoking cessation counseling to all subjects, an important level of support that may not be routinely available to many patients in usual clinical practice. Second, the trials excluded smokers with past or current serious medical illnesses.
Clinical trials showed that the most common adverse effects of varenicline are abnormal dreams, constipation, flatulence, headache, nausea and vomiting. After the drug’s approval, reports of serious neuropsychiatric adverse effects in patients treated with varenicline streamed into the FDA. These adverse effects included changes in mood (such as depression and mania), psychosis, hallucinations, paranoia, delusions, aggression, hostility, agitation, anxiety and panic attacks. The warning alerted health care professionals and patients to the drug’s potential to cause some of the aforementioned neuropsychiatric adverse effects.
However, the FDA decided to remove the warning altogether in December 2016. They made this decision based on the results of a single trial, known as EAGLES, which was mandated by the agency to determine the neuropsychiatric safety of varenicline. The trial did not find a significant increase in the rates of neuropsychiatric adverse effects that interfered with usual daily functioning with use of either varenicline or bupropion relative.
When you try to quit smoking, with or without CHANTIX (varenicline), you may have symptoms that may be due to nicotine withdrawal, including urge to smoke. Always take CHANTIX after eating, with a full glass of water. If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose. Just take your next dose at your regular time. You should try to stop smoking on your quit date, but if you slip up and smoke, it doesn’t mean you have failed. Keep trying! Some people need to take CHANTIX for a few weeks for it to work best.
During the first week of taking CHANTIX, you will slowly increase the dose over 1 week to give it time to build up in your body. After you start taking CHANTIX, you can smoke until your quit date. There are 3 ways to quit with CHANTIX, and your quit date will depend on which way you choose. Most people will take CHANTIX for 3 months. If you have completely quit smoking by the end of 3 months, your healthcare provider may prescribe CHANTIX for another 3 months to help you stay smoke-free. Or, if you and your doctor decide that the Gradual Quit Approach is right for you, you will take CHANTIX for a total of 6 months.
If you smoke, you should try to quit. If you have tried to quit in the past and relapsed, do not worry! Most smokers have to make several attempts to stop before finally succeeding (the average number of tries is around four before successfully quitting). Seeing your doctor or a professional smoking cessation counselor is a good first step to devise a long-term strategy for quitting. If you decide to use a smoking cessation drug, talk to your doctor about trying the minimum effective dose of one of the currently available nicotine replacement therapies, along with some form of counseling with a health care professional. Not all smokers respond the same way to every nicotine replacement therapy, so you should try several formulations, such as the patch and the inhaled variety, to see which one works best for you. If nicotine replacement therapy is unsuccessful, talk to your doctor about treatment with varenicline, it is effective drug for smoking cessation.