Drug Safety Labeling Changes - November 2014

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November 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
Arava (leflunomide) Tablets-ContraindicationsWarningsPrecautionsAdverse Reactions---
Unasyn (ampicillin sodium/sulbactam sodium) Injection-ContraindicationsWarnings-Adverse Reactions---
Adcetris (brentuximab vedotin) for Injection--WarningsPrecautions----
AVELOX (moxifloxacin hydrochloride) 400 mg Tablets and AVELOX (moxifloxacin hydrochloride in sodium chloride injection) IV --WarningsPrecautions----
Bosulif (bosutinib) Tablets--WarningsPrecautions----
Cubicin (daptomycin for injection) Intravenous--WarningsPrecautions----
Cymbalta (duloxetine) Delayed-release Capsules--WarningsPrecautions----
Lopid (gemfibrozil) Tablets--WarningsPrecautions----
Sensipar (cinacalcet hydrochloride) Tablets--WarningsPrecautionsAdverse Reactions---
Sovaldi (sofosbuvir) Tablet--WarningsPrecautions----
Drug Name BW C W P AR PPI MG PCI
Taxotere (docetaxel) Injection Concentrate--WarningsPrecautions----
Votrient (pazopanib hydrocholoride) Tablets--WarningsPrecautions----
Zelboraf (vemurafenib) Tablet--WarningsPrecautionsAdverse Reactions---
Cardizem (diltiazem hydrochloride) Tablets---PrecautionsAdverse Reactions---
Foscavir (foscarnet sodium) Injection---PrecautionsAdverse Reactions---
Mycobutin (rifabutin) Capsules---PrecautionsAdverse Reactions---
Mytelase (ambenonium chloride) Tablets---PrecautionsAdverse Reactions---
Sylatron (peginterferon alfa-2b)---Precautions----
Actemra (tocilizumab)----Adverse Reactions---
Advair Diskus (fluticasone propionate and salmeterol xinafoate inhalation powder), Advair HFA Inhalation Aerosol----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Depacon (valproate sodium) Injection----Adverse Reactions---
Depakene (valproic acid) Capsules and Oral Solution----Adverse Reactions---
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules), ----Adverse Reactions---
Depakote ER (divalproex sodium) Extended Release Tablets ----Adverse Reactions---
Flovent Diskus (fluticasone propionate inhalation powder)----Adverse Reactions---
Flovent HFA Inhalation Aerosol ----Adverse Reactions---
Furadantin (nitrofurantoin) Oral Suspension  ----Adverse Reactions---
Nucynta (tapentadol) Oral Solution----Adverse Reactions---
Omniscan (Gadodiamide) Injection,----Adverse Reactions---
Omniscan (Gadodiamide) Pharmacy Bulk Package Injection  ----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
OptiMARK Injection,----Adverse Reactions---
OptiMARK in Plastic Container,----Adverse Reactions---
OptiMARK Pharmacy Bulk Package Injection  ----Adverse Reactions---
Singulair (montelukast sodium) Tablets, Chewable Tablets and Oral Granules----Adverse Reactions---
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