Thursday, September 17, 2009

Wellbutryn and Zyban

SPINE SAFETY CAUTIONARY NOTICE:
Information for Healthcare Professionals: Drug Safety Labeling Changes -Wellbutrin (bupropion hydrochloride) Tablets and Sustained-Release Tablets
According to MedWatch, the Food and Drug Administration (FDA) notified healthcare professionals that BOXED WARNINGS, WARNINGS, PRECAUTIONS and MEDICATION GUIDE text for Wellbutrin (bupropion hydrochloride) tables and sustained-release tablets have been updated to address neuropsychiatric symptoms and suicide risk in smoking cessation treatment.

The revised BOXED WARNING indicates the following:
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.

Read the complete summary of MedWatch safety labeling changes at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm176817.htm

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