FDA Requires Manufacturers of Smoking Cessation Aids Add New Boxed Warnings

Jessica Smagacz

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A recent FDA alert reported that FDA is requiring the manufacturers of the smoking cessation aids varenicline (Chantix) and bupropion (Zyban and generics) add new Boxed Warnings.

In addition to adding new Boxed Warnings, the manufacturers are required to develop patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms in patients using these products.

Symptoms include:

-changes in behavior

-hostility

-agitation

-depressed mood

-suicidal thoughts and behavior

-and attempted suicide

These changes that are required to the prescribing information & Medication Guide for patients are also required for bupropion products (Wellbutrin and generics) that are for the treatment of depression and seasonal affective disorder.

FDA, as a result of receiving continued postmarketing adverse event reports for varenicline and bupropion, is requiring these added warnings.

“Healthcare professionals should advice patients to stop taking varenicline or bupropion and contact a healthcare provider immediately if they experience agitation, depressed mood, and any changes in behavior that are not typical of nicotine withdrawal, or if they experience suicidal thoughts or behavior.”