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Bupropion

Suicidal Thoughts and Behaviors; and Neuropyschiatric Reactions

Use in Treating Psychiatric Disorders

  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in short-term studies in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders.
  • Anyone considering the use of this drug or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. 
  • Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older.
  • Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide.
  • Patients of all ages who are started on therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. 
  • Families and care givers should be advised of the need for close observation and communication with the prescriber. 
  • This drug is not approved for use in pediatric patients.
  • See Warnings:  Clinical Worsening and Suicide Risk, Precautions:  Information for Patients, and Precautions:  Pediatric Use

 Use in Smoking Cessation Treatment

  • Wellbutrin AND Aplenzin products are not approved for smoking cessation treatment, but bupropion under the name ZYBAN is approved for this use.
  • Serious neuropsychiatric reactions have been occurred  in patients taking bupropion for smoking cessation.
  • The majority of these reactions occurred during bu[propion treatment, but some occurred in the context of discontinuing treatment.
  • In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke.
  • Wellbutrin and Aplenzin are not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

Monitoring and Patient Counseling in Smoking Cessation Treatment:

  • 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 bupropion in the post-marketing experience. When symptoms were reported, most were during bupropion treatment, but some were following discontinuation of varenicline treatment. These events have occurred in patients with and without pre-existing psychiatric disease, some have experienced worsening of their psychiatric illnesses.
  • Advise patients and caregivers that the patient should stop taking this drug and contact a health care provider immediately if agitation, hostility, depressed mood or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior.
  • In many post-marketing cases, resolution of symptoms after discontinuation of bupropion was reported, although in some cases the symptoms persisted: therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

FDA and Industry Communications

Dosage Adjusment and Monitoring in Patients Developing Aminotransferase Abnormalities: Dear Health Professional Letter (March 2006)

Information for Healthcare Professionals: New Black Box Warnings for Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) 2009

FDA Patient Medication Guide

Approved Risk Evaluation and Mitigation Strategies (REMS)

 

Patient Counseling Information

Bupropion Hydrochloride

Wellbutrin

Zyban

Medication Guides

Patient Medication Guide

Package Inserts

Bupropion

Additional Information

Updated January 2018