Label Changes for:

Wellbutrin (bupropion hydrochloride) tablets, Sustained-Release, and Extended Release (XL) tablets 

July 2009

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2009

BOXED WARNING (text updated)

  • All patients being treated with bupropion for smoking cessation treatment should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking Zyban in the postmarketing experience. When symptoms were reported, most were during treatment with Zyban, but some were following discontinuation of treatment with Zyban.
  • In many postmarketing cases, resolution of symptoms after discontinuation of Zyban was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

WARNINGS

Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
  • Serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation. These have included changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide.
  • When symptoms were reported, most were during bupropion treatment, but some were following discontinuation of bupropion therapy.
  • All patients being treated with bupropion as part of smoking cessation treatment should be observed for neuropsychiatric symptoms or worsening of pre-existing psychiatric illness.
  • In many postmarketing cases, resolution of symptoms after discontinuation of ZYBAN was reported, although in some cases the symptoms persisted, therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

PRECAUTIONS

Renal Impairment
  • Addition of a description of a study comparing the use of bupropion in normal subjects and patients with moderate-to-severe renal impairment
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment
  • Furthermore, some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation aggression, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide

MEDICATION GUIDE

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior
  • entire section updated
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