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.

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