MedWatch June 2013 Safety Labeling Changes

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The MedWatch June 2013 Safety Labeling Changes posting includes over 44 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm359843.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:

Adderall XR (mixed amphetamine salts) capsules
Aldactone (spironolactone) Tablets
Aldactazide (spironolactone/HCTZ) Tablets
Azactam (aztreonam injection)in GALAXY Plastic Container and Azactam (aztreonam) for injection
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) tablets
Concerta (methylphenidate HCl) Extended-Release tablets
Daytrana (methylphenidate) transdermal system
Depacon (valproate sodium) Injection
Depakene (valproic acid) Capsules and Oral Solution, Depakote (divalproex sodium) Delayed Release and Depakote ER (Extended Release) Tablets, and Depakote Sprinkle Capsules
Dexedrine (dextroamphetamine sulfate) Spansule
Edurant (rilpivirine) tablet
Elaprase (idursulfase) injection
Exelon (rivastigmine) Patch
Eylea (aflibercept) Injection
Focalin (dexmethylphenidate hydrochloride) Tablets and Focalin XR (Extended-Release) Capsules
Fycompa (perampanel) Tablets
Immune Globulin Products (Human) intravenous, subcutaneous, and intramuscular
Istodax (romidepsin) lyophilized powder
Jentadueto (linagliptin and metformin hydrochloride) tablets
Lamisil (terbinafine hydrochloride) Tablets
Lamisil (terbinafine hydrochloride) Oral Granules
Metadate CD (methylphenidate HCl) Extended-Release Capsules
Methylin (methylphenidate HCl) Oral Solution and Chewable tablets
Mozobil (plerixafor) injection
Nordette (levonorgestrel/ethinyl estradiol) tablets
Ritalin (methylphenidate hydrochloride) Tablets, Ritalin SR (Extended-Release Tablets), and Ritalin LA (Extended-Release Capsules)
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution
Stavzor (valproic acid) Delayed Release Capsules
Suprenza (phentermine hydrochloride) orally dissolving tablets
Tasigna (nilotinib) capsules
Tradjenta (linagliptin) tablets
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets
Tykerb (lapatinib) tablets
Urso and Urso Forte (ursodiol) tablets
Vyvanse (lisdexamfetamine dimesylate) capsules
Welchol (colesevelam) Tablets and Oral Suspension

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