Drug Safety Labeling Changes - January 2011

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January 2011

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
Carbatrol (carbamazepine) Extended-Release Capsules-Contraindications-Precautions----
Ery-Ped (erythromycin ethylsuccinate) Liquids-ContraindicationsWarningsPrecautionsAdverse Reactions---
PCE (erythromycin particles in tablets) Dispertab Tablet-ContraindicationsWarningsPrecautionsAdverse Reactions---
Gelnique (oxybutynin chloride) 10% gel-ContraindicationsWarnings-----
Uloric (febuxostat tablets)-Contraindications-PrecautionsAdverse Reactions---
Cyklokapron (tranexamic acid) Injection--Warnings-----
Oxytrol (oxybutynin transdermal system)--WarningsPrecautions----
Reclast (zoledronic acid) Injection--WarningsPrecautions----
Sanctura (trospium chloride) tablets--WarningsPrecautions----
Sanctura XR (trospium chloride extended release capsules)--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Tessalon (benzonatate) Perles and Capsules--WarningsPrecautionsAdverse Reactions---
Trelstar (triptorelin palmoate) Depot--WarningsPrecautions----
Zoladex (goserelin acetate) implant, 3.6 mgZoladex (goserelin acetate) implant, 10.8 mg--WarningsPrecautions----
Viadur (leuprolide acetate implant)---Precautions----
Advicor (niacin extended release/lovastatin) Tablets----Adverse Reactions---
Astepro (azelastine hydrochloride) Nasal Spray----Adverse Reactions---
Synarel (nafarelin acetate) Nasal Solution 2mg/mL----Adverse Reactions---
Advair HFA (fluticasone propionate and salmeterol xinafoate) Inhalation Aerosol--------
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