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The MedWatch October 2014 Safety Labeling Changes posting includes 37 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.
The "Summary Page" table provides a listing of product names and safety labeling sections revised:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm422591.htm
The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, or WARNINGS and PRECAUTIONS sections:
Agrylin (anagrelide hydrochloride) Capsules
Aldactazide (spironolactone/hydrochlorothiazide) Tablets
Aldactone (spironolactone) Tablets
Ambien (zolpidem tartrate)
BreathID System 13C-Urea Breath Test
Cymbalta (duloxetine hydrochloride) Capsules
Dilatrate SR (isosorbide dinitrate) Sustained Release Tablets
Docefrez (docetaxel) Injection
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets
Eligard (Leuprolide Acetate for Injectable Suspension)
Eylea (aflibercept) Injection
Ilaris (canakinumab)
Istodax (romidepsin) lyophilized powder
Keppra (levetiracetam) Injection
Lincocin (lincomycin hydrochloride injection, USP) Sterile Solution
Minocin (minocycline for injection) Intravenous
Mircera (methoxy polyethylene glycol-epoetin beta)
Monoket (isosorbide mononitrate) Tablets
Nitro-Dur (nitroglycerin) Transdermal Infusion System
Nitroglycerin 5 Percent in Dextrose for Injection
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use
Saphris (asenapine) sublingual tablets
Teriflunomide (Aubagio)
Velcade (bortezomib) for Injection
Xeloda (capecitabine) Tablets
Xiaflex (collagenase clostridium histolyticum)
Zetonna (ciclesonide) Nasal Aerosol
Zoladex (Goserelin acetate) Implant
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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