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  • FDA notice on Wellbutrin label change is posted

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    Old 01-27-2003, 01:11 PM   #1
    princess_gracey
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    Post FDA notice on Wellbutrin label change is posted

    FYI. Go to the FDA's site and this message here: [url="http://www.fda.gov/medwatch/SAFETY/2002/oct02.htm#wellbu"]http://www.fda.gov/medwatch/SAFETY/2002/oct02.htm#wellbu[/url]

    WELLBUTRIN (bupropion HCl) Immediate-Release Tablet & WELLBUTRIN SR (bupropion HCl) Sustained-Release Tablets

    [October 2 & 22, 2002: GlaxoSmithKline]

    Wellbutrin SR & Wellbutrin Label

    CONTRAINDICATIONS

    [Moved from WARNINGS]

    (WELLBUTRIN & WELLBUTRIN SR) [are] contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

    PRECAUTIONS

    Information for Patients:

    Patients should be told that the excessive use or abrupt discontinuation of alcohol or sedatives (including benzodiazepines) may alter the seizure threshold. Some patients have reported lower alcohol tolerance during treatment with (WELLBUTRIN & WELLBUTRIN SR) Patients should be advised that the consumption of alcohol should be minimized or avoided.

    Drug Interactions:

    Levodopa and Amantadine: Limited clinical data suggest a higher incidence of adverse experiences in patients receiving bupropion concurrently with either levodopa or amantadine. Administration of (WELLBUTRIN & WELLBUTRIN SR) Tablets to patients receiving either levodopa or amantadine concurrently should be undertaken with caution, using small initial doses and gradual dose increases.

    Drugs That Lower Seizure Threshold:

    Alcohol: In post-marketing experience, there have been rare reports of adverse

    neuropsychiatric events or reduced alcohol tolerance in patients who were drinking alcohol during treatment with (WELLBUTRIN & WELLBUTRIN SR) The consumption of alcohol during treatment with (WELLBUTRIN & WELLBUTRIN SR) should be minimized or avoided (also see CONTRAINDICATIONS).

    Wellbutrin SR label

    ADVERSE REACTIONS

    Other Events Observed During the Clinical Development and Postmarketing Experience of Bupropion:

    Nervous System: hallucinations- added

    The Patient Information insert has been updated to reflect the labeling revisions above regarding alcohol. Contact the company for a copy of the new labeling.

     
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