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FDA approves stronger, expanded warnings on Chantix labeling
August 27th, 2009 by Kurt Niland
The Food and Drug Administration has approved the new labeling for Chantix packaging. In July, we reported that the agency said it would require stronger warnings on all Chantix labeling, as well as packaging for other smoking cessation drugs Wellbutrin and Zyban (bupropion hydrochloride). All of the drugs have been linked to serious behavioral changes and other symptoms.
The new boxed warning on Chantix labeling will read: “Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking Chantix.”
Revised warnings state that neuropsychiatric symptoms and suicidality have been found in patients using Chantix. The post-marketing reports include 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 warnings state that patients should stop taking Chantix immediately if they experience any of the adverse neuropsychiatric symptoms or exhibit changes in thinking and acting that aren’t characteristic of the patient.
The new Chantix warnings also caution that “there have been post-marketing reports of traffic accidents, near-miss incidents in traffic, or other accidental injuries in patients taking Chantix.
The new warnings also advise that “resolution of symptoms after discontinuation of Chantix was reported,” but that the symptoms persisted in some cases.
Warnings for Wellbutrin and Zyban are to carry warnings similar to those for Chantix. “Patients should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide.”
