Update July 2011

I recently saw TV ads promoting the drug Chatrix for smoking cessation. TV drug ads in the US are created by professional advertising agencies who know how to present  products as highly desirable. To the credit of the USFDA, admission of adverse effects is required  in the ads. Even thought the drug warnings may be dire, the drug ads are cleverly designed to minimize the effect of any bad news. Chantrix is not really effective as an agent of longterm smoking cessation (only 1 person in ten is a non-smoker after one year- beyond one year nobody knows what happens to the 10% who quit) and the recognition of its negative effects, beyond the price, increases concern about its use.

Furberg stated that MedWatch data showed Chatrix to be one of the worst drugs on the market in terms of side effects. "It is associated with sudden loss of consciousness, which has led it to be banned from use in pilots and truck drivers, and the Department of Defense has discouraged its use in army personnel working with missiles. But what about all the people who drive cars every day? It also has the most reports of aggression, hostility and violence of any drug marketed, and these are only the reactions that have actually been reported to the FDA, so just represent the tip of the iceberg... (there are) reports of suicide and self-inflicted injury with the drug."  Singh S, Loke YK, Spangler JG, et al. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. CMAJ 2011. Available at: http://www.cmaj.ca

Update 2009 Reports of Suicidal Thoughts, Aggressive Behavior

US Food and Drug Administration (FDA) has informed healthcare professionals about reports of suicidal thoughts as well as some aggressive and erratic behavior in patients who have taken varenicline (Chantix, Pfizer), a smoking-cessation product.  Problems reported were new-onset depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating treatment with varenicline. In one highly publicized case, the FDA notes, erratic behavior led to the death of a patient using varenicline to quit smoking. There are additional reports of patients experiencing drowsiness that affected their ability to drive or operate machinery, the FDA alert notes.

Susan Jeffrey. Medscape Medical News Nov 20 2007. The complete MedWatch safety summary, including a link to the FDA Early Communication Sheet about the ongoing safety review on this issue, can be found at  http://www.fda.gov/medwatch/safety/2007/safety07.htm#Chantix.

On July 1,2009 the US FDA approved  labeling revisions for varenicline tartrate tablets (Chantix, Pfizer, Inc) that include a black-box warning regarding the risk for serious neuropsychiatric events. The warning was based on postmarketing reports of changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide. The FDA also warned that motor vehicle crashes, near-miss accidents, and other unintentional injuries have occurred in patients taking varenicline. In some cases, patients reported somnolence, dizziness, loss of consciousness, or difficulty concentrating, potentially resulting in impairment. Patients should be cautious when driving, operating heavy machinery, or engaging in other potentially hazardous activities until they know how varenicline will affect them.  See Yael Waknine. FDA Safety Changes: Varenicline (Chantix) Linked to Risk for Serious Neuropsychiatric Events .Medscape Medical News. Aug 2009. Accessed Online Feb 2010.

The developers of this drug stated: "We have pursued alpha4 beta2 nicotinic receptor partial agonists to inhibit dopaminergic activation produced by smoking while simultaneously providing relief from the craving and withdrawal syndrome that accompanies cessation attempts. Varenicline displays high alpha4 beta2 nAChR affinity and the desired dopaminergic profile."

The problem with this apparently good idea is that this drug acts on core structures in the brain that control emotions, regulate behavior and interface body control with cognitive centers.  Stimulation of nicotinic receptors in the brain, particularly alpha4 beta2 receptors, releases dopamine in the meso-limbic area of the brain. If you are going to add this chemical to the bad mix of chemicals that the patient is already consuming, watch out. Some bad things are going to happen.

Several drugs have been prescribed to smokers; it is a potpourri of  different chemicals: bupropion, nortriptyline, clonidine and nicotine patch, gum, inhaler, lozenge and nasal spray. 80% of users of these drugs return to smoking within the first year.

Yes, smoking cessation has major health benefits for men and women of all ages and smokers are addicted to nicotine.  The solution is really easy. Just stop smoking. Like all addictions, smoking thrives in groups that accept the habit and disappears in groups that reject the habit.

The Brain Mind Center

Topics from the book,  The Human Brain by Stephen Gislason MD

Further reading:   Alpha Nutrition Program, Neuroscience Notes,  Intelligence and Learning

Order Books: Click the Add to Cart buttons on the left  to order printed books from Alpha Online ( mail delivery to US and Canada).
Download eBooks Click the Download button on the right for eBook (PDF file) downloads from Persona Digital Online.

Human Brain in Health and Disease

Neuroscience Notes

Learn More about Alpha BMX, elemental nutrient formula.

Two Books Alpha Nutrition Program, Human Brain and the Alpha Alpha BX formula are bundled as the Brain Rescue Starter Pack, available online at a  discount. More Information about the Brain Starter Pack.    

You are viewing the Brain Mind Center at Alpha Online, a Division of Environmed Research, founded in 1984 at Vancouver, BC, Canada. Online Since 1995. Alpha Nutrition is a trademark and a division of Environmed Research Inc.  All Alpha Education books, eBooks and Starter packs are ordered online.  We are located at Sechelt, close to Vancouver, British Columbia, Canada.