The Medical Letter on Drugs and Therapeutics
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Varenicline (Chantix) Warnings: Risk Versus Benefit

The nicotine receptor partial agonist varenicline (Chantix – Pfizer) appears to be the most effective drug available to treat tobacco dependence,1 but the FDA has added a warning to the package insert about neuropsychiatric symptoms and exacerbations of preexisting psychiatric illness associated with its use. Agitation, hostility, depressed mood, suicidal ideation and suicidal behavior have been reported as postmarketing adverse events in patients who took varenicline and stopped smoking and in those who took the drug and continued to smoke.

MENTAL DISORDERS IN SMOKERS — Smoking itself is associated with psychiatric disease.2-4 Psychiatric symptoms including suicidal ideation and completed suicide have been associated both with smoking and with smoking cessation. A dose-response relationship has been described between smoking and suicide.5 ... more      

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