FDA ISSUES PUBLIC HEALTH ADVISORY ON CHANTIX: STOP SMOKING MEDICINE POSSIBLE ERRATIC BEHAVIOR

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The stop smoking medicine Chantix that works by a different more novel mechanism than other smoking cessation drugs has run into more problems. The FDA has updated as of Feb. 2008 it's warning about possible psychiatric side effects from the stop smoking drug Chantix. "As the agency's review of the adverse event reports proceeds, it appears increasingly likely that there may be an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA has requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the warnings and precautions section of the Chantix prescribing information, or labeling".




The FDA first informed the public about the possibility of serious neuropsychiatric symptoms on November 20, 2007. Health care professionals (like doctors), patients, patients' families, and caregivers should be alert to and monitor for changes in mood and behavior in patients treated with Chantix. Symptoms may include anxiety, nervousness, tension, depressed mood, unusual behaviors and thinking about or attempting suicide. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of varenicline therapy".

"Patients should immediately report changes in mood and behavior to their doctor.
Vivid, unusual, or strange dreams may occur while taking Chantix. Patients taking Chantix may experience impairment of the ability to drive or operate heavy machinery".The FDA had previously written an "early communication" about reported problems with behavior of people taking Chantix.








"The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment."













"The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking".

FDA Issues Public Health Advisory on Chantix







Chantix is a relatively new medicine to stop smoking. Chantix works by a different mechanism than the previous smoking cessation drugs. "The active ingredient in Chantix, varenicline tartrate, is a new molecular entity that received a priority FDA review because of its significant potential benefit to public health. Chantix acts at sites in the brain affected by nicotineand may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking. FDA Approves Novel Medication for Smoking Cessation




The hodge podge of previous remedies to stop smoking include everything from acupunture and hypnosis, which by the way, do work for some people, to nicotine patches and an anti depressant. Zyban is actually the anti depressant Wellbutrin.
The single most important factor in successfully stopping smoking is a very strong desire and reason to stop smoking.






"Cigarette smoking is a very difficult habit to break due in large part to nicotine dependence or addiction" said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Chantix therapy has proven to be effective in smokers motivated to quit and will provide another tool for physicians to use for the millions of smokers who want to quit."




Take a look at the American Lung Association's Free Online Smoking Cessation Program




The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for approximately 25 years. In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban (bupropion).



The approved course of Chantix treatment is 12 weeks. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of Chantix treatment to further increase the likelihood of long-term smoking cessation. In clinical trials, the most common adverse effects of Chantix were nausea, headache, vomiting, flatulence (gas), insomnia, abnormal dreams, and dysgeusia (change in taste perception)."

Chantix was Molecule of the Month