Drug Safety Labeling Changes - June 2013

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June 2013

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Depacon (valproate sodium) Injection, Depakene (valproic acid) Capsules and Oral SolutionBoxed Warning-WarningsPrecautions----
Depakote (divalproex sodium) Delayed Release andBoxed Warning-WarningsPrecautions----
Depakote ER (Extended Release) Tablets, Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules)Boxed Warning-WarningsPrecautions----
Elaprase (idursulfase) injection, for intravenous useBoxed Warning-WarningsPrecautionsAdverse Reactions---
Immune Globulin Products (Human) intravenous, subcutaneous, and intramuscularBoxed Warning-------
Aldactazide (spironolactone/HCTZ) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Exelon (rivastigmine) Patch-ContraindicationsWarningsPrecautions----
Mozobil (plerixafor) injection, subcutaneous-ContraindicationsWarningsPrecautionsAdverse Reactions---
Urso and Urso Forte (ursodiol) tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Concerta (methylphenidate HCl) Extended-Release tablets--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Daytrana (methylphenidate) transdermal system--WarningsPrecautions----
Dexedrine (dextroamphetamine sulfate) Spansule, sustained release capsules--WarningsPrecautions----
Focalin XR (Extended-Release) Capsules--WarningsPrecautions----
Focalin (dexmethylphenidate hydrochloride) Tablets and--WarningsPrecautions----
Fycompa (perampanel) Tablets--WarningsPrecautions----
Lamisil (terbinafine hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Lamisil (terbinafine hydrochloride) Oral Granules--WarningsPrecautionsAdverse Reactions---
Methylin (methylphenidate HCl) Oral Solution and Chewable tablets--WarningsPrecautions----
Ritalin (methylphenidate hydrochloride) Tablets,--WarningsPrecautions----
Ritalin SR (Extended-Release Tablets), and--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Ritalin LA (Extended-Release Capsules)--WarningsPrecautions----
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent) Oral Solution--WarningsPrecautions----
Suprenza (phentermine hydrochloride) orally dissolving tablets--WarningsPrecautions----
Tykerb (lapatinib) tablets--WarningsPrecautions----
Welchol (colesevelam) Tablets and Oral Suspension--WarningsPrecautionsAdverse Reactions---
Azactam (aztreonam injection)in GALAXY Plastic Container and Azactam (aztreonam) for injection---Precautions----
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) fixed dose combination (FDC) tablets---Precautions----
Edurant (rilpivirine) tablet---Precautions----
Eylea (aflibercept) Injection---Precautions----
Nordette (levonorgestrel/ethinyl estradiol) tablets---Precautions----
Drug Name BW C W P AR PPI MG PCI
Tasigna (nilotinib) capsules---Precautions----
Abraxane Injectable Suspension (paclitaxel protein-bound particles (albumin-bound)) for injectable suspension----Adverse Reactions---
Cordran SP (flurandrenolide) Cream and Cordran Ointment----Adverse Reactions---
Isentress (raltegravir potassium) tablet and chewable tablet----Adverse Reactions---
Nexavar (sorafenib tosylate) tablet----Adverse Reactions---
Sprycel (dasatinib) Tablets----Adverse Reactions---
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