Alerts
Bupropion (Zyban and generics) - Neuropsychiatric Events and Suicidality Warnings added to the Prescribing Information - Update
July 6, 2009
In November 2007, FDA began reviewing post-marketing data for bupropion, in response to reports of neuropsychiatric side effects (eg, suicidal thoughts, suicidal behavior, depression, agitation, hostility, other aggressive behavior, erratic behavior, drowsiness) associated with this agent. The role of bupropion in these behaviors was initially uncertain because nicotine withdrawal can cause unfavorable symptoms and worsen pre-existing psychiatric illness. However, some cases have occurred in patients without previous psychiatric disease, in treated patients who continued smoking, and in patients who had discontinued bupropion.
After reviewing postmarketing data, the FDA found an association between bupropion use and these side effects, as well as a temporal relationship with suicidality in patients without previous psychiatric disease. The FDA has approved revisions to the product labeling to address the risk of symptoms such as agitation, aggressive and erratic behavior, depressed mood, suicidal ideation, and suicide attempts. As of July 2009, a new boxed warning will be added to the bupropion product labeling, including Zyban, Wellbutrin and generic products. In addition, FDA now requires that pharmacists dispense a Medication Guide to the patient with every prescription for bupropion. GlaxoSmithKline must also conduct a clinical trial evaluating the frequency of these events in patients with and without psychiatric disorders.
The FDA encourages healthcare professionals to consider the safety risks of bupropion. Discuss these risks with patients prior to starting therapy, and inquire about any previous history of psychiatric illness. Monitor patients for mood changes (eg, agitation, depression), behavior changes, suicidality, or drowsiness after starting bupropion therapy. Educate patients and their family members to also monitor for such symptoms. If symptoms occur, advise patients to discontinue therapy and contact a healthcare provider immediately for treatment. Continue monitoring until symptoms resolve. Educate patients to use caution when operating machinery and vehicles until they are familiar with bupropion’s effects.
The MedGuide should be given to patients receiving bupropion to advise them of the risks and precautions that can be taken. The MedGuide can be obtained online (see link below).
Additional information is available at the following links:
- Medwatch Alerts:
- July 1, 2009 (note: also includes information on varenicline, which is addressed in a separate alert):
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ SafetyAlertsforHumanMedicalProducts/ucm170090.htm - FDA Press Release:
- Public Health Advisories:
- Information for Healthcare Professionals:
- July 1, 2009 (note: also includes information on varenicline, which is addressed in a separate alert):
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ DrugSafetyInformationforHeathcareProfessionals/ucm169986.htm - Bupropion (Zyban) product information, 2007 (without boxed warning):
http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020711s029lbl.pdf - Bupropion (Zyban) MedGuide, 2007 (without boxed warning):
http://www.fda.gov/downloads/Drugs/DrugSafety/ucm089835.pdf
The FDA requires the distribution of Medication Guides for drugs determined to be a serious and significant public health concern. This requirement applies primarily to medications dispensed in the outpatient setting (refer to Code of Federal Regulations 21CFR208.1). However, it may be appropriate to educate inpatients about the potential hazards of prescription medications, at the clinician’s discretion. The complete list of drugs that require a Medication Guide as part of the FDA-regulated product labeling is available online at: http://www.fda.gov/cder/Offices/ODS/labeling.htm.
Updated
July 6, 2009. University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
