FDA MedWatch - November 2004 Safety Labeling Changes Posted

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    MedWatch - The FDA Safety Information and Adverse Event Reporting Program

    Safety-related drug labeling changes for November 2004 have been posted on
    the MedWatch website.

    The November 2004 posting includes 38 drug products with safety labeling
    changes to the CONTRAINDICATIONS, BOXED WARNING, WARNINGS, PRECAUTIONS, or
    ADVERSE REACTIONS sections. The Summary page --

    http://www.fda.gov/medwatch/SAFETY/2..._quickview.htm

    -- provides drug names and a listing of the sections changed. The Detailed
    view --

    http://www.fda.gov/medwatch/SAFETY/2004/nov04.htm

    -- includes sections/subsections changed and a description of new or
    modified safety information in the Contraindications, Boxed Warning, or
    Warnings sections. The full labeling may be accessed by clicking on the drug
    name in the detailed view.

    The following drugs had modifications to the CONTRAINDICATIONS and/or
    WARNINGS/BOXED WARNINGS sections:

    Bextra (valdecoxib) Tablets
    Canasa (mesalamine, USP) Rectal Suppositories
    Cosmegen (dactinomycin for injection)
    Depo-Provera Contraceptive Injection (medroxyprogesterone acetate injectable
    suspension)
    Norditropin Cartridges (somatropin [rDNA origin] injection)
    Phenergan (promethazine HCl) Tablets and Suppositories
    Robinul (glycopyrrolate injection, USP) Injection
    Saizen (somatropin [rDNA origin] for injection)
    Striant (testosterone buccal system) mucoadhesive
    Tracleer (bosentan) Tablets
    Altace (ramipril) Capsules
    AndroGel (testosterone gel) 1%
    Levaquin (levofloxacin) Tablets, Oral Solution and Injection
    Levaquin (levofloxacin in 5% dextrose) Injection
    Naprosyn (naproxen suspension)
    Naprosyn (naproxen tablets)
    EC-Naprosyn (naproxen delayed -release tablets)
    Anaprox/Anaprox DS (naproxen sodium) Tablets
    Remodulin (treprostinil sodium) Injection
    Tabloid (thioguanine) Tablets
    Zyban (bupropion hydrochloride) Sustained-Release Tablets
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