Drug Safety Labeling Changes - October 2014

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October 2014

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
Cymbalta (duloxetine hydrochloride) CapsulesBoxed Warning-------
Mircera (methoxy polyethylene glycol-epoetin beta) Boxed WarningContraindicationsWarningsPrecautions----
Dilatrate SR (isosorbide dinitrate) Sustained Release Tablets-Contraindications-Precautions----
Monoket (isosorbide mononitrate) Tablets-Contraindications-Precautions----
Nitro-Dur (nitroglycerin) Transdermal Infusion System-Contraindications-Precautions----
Nitroglycerin 5 Percent  in Dextrose for Injection-Contraindications-Precautions----
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use-ContraindicationsWarningsPrecautions----
Xiaflex (collagenase clostridium histolyticum)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Agrylin (anagrelide hydrochloride) Capsules--WarningsPrecautions----
Aldactazide (spironolactone/hydrochlorothiazide) Tablets--Warnings-----
Drug Name BW C W P AR PPI MG PCI
Aldactone (spironolactone) Tablets--Warnings-----
Ambien (zolpidem tartrate)--WarningsPrecautions----
BreathID System 13C-Urea Breath Test--WarningsPrecautions----
Docefrez (docetaxel) Injection--WarningsPrecautions----
Dutoprol (metoprolol succinate extended release/hydrochlorothiazide) tablets--WarningsPrecautionsAdverse Reactions---
Eligard (Leuprolide Acetate for Injectable Suspension)--WarningsPrecautions----
Eylea (aflibercept) Injection --WarningsPrecautions----
Ilaris (canakinumab)--WarningsPrecautions----
Istodax (romidepsin) lyophilized powder--WarningsPrecautions----
Keppra (levetiracetam) Injection--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Lincocin (lincomycin hydrochloride injection, USP) Sterile Solution--WarningsPrecautions----
Minocin (minocycline for injection) Intravenous--Warnings-----
Saphris (asenapine) sublingual tablets--WarningsPrecautions----
Teriflunomide (Aubagio)--WarningsPrecautions----
Velcade (bortezomib) for Injection--WarningsPrecautions----
Xeloda (capecitabine) Tablets--WarningsPrecautions----
Zetonna (ciclesonide) Nasal Aerosol--WarningsPrecautions----
Zoladex (Goserelin acetate) Implant--WarningsPrecautions----
Aciphex (rabeprazole sodium) Delayed-Release Tablets---Precautions----
Diflucan (fluconazole) Tablets and Powder for Oral Suspension---Precautions----
Drug Name BW C W P AR PPI MG PCI
Naftin (naftifine hydrochloride) gel, cream---Precautions----
Topamax (topiramate) Sprinkle Capsules---Precautions----
Cancidas (caspofungin acetate) Injection----Adverse Reactions---
Chantix (varenicline) Tablets----Adverse Reactions---
Flomax (tamsulosin hydrochloride) Capsules----Adverse Reactions---
Lialda (mesalamine) delayed-release tablets----Adverse Reactions---
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring)--------
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