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Drug Safety Labeling Changes - February 2016

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February 2016

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
Fluorescite (fluorescein injection)-ContraindicationsWarningsPrecautionsAdverse Reactions---
Gilenya (fingolimod) Capsules-ContraindicationsWarningsPrecautions----
Vistaril (hydroxyzine pamoate) Capsules and Oral Suspension-Contraindications-PrecautionsAdverse Reactions---
Atacand (candesartan cilexetil) Tablets--WarningsPrecautions----
Avalide (irbesartan/hydrochlorothiazide) Tablets--WarningsPrecautionsAdverse Reactions---
Cimzia (certolizumab pegol) Lyophilized Powder and Solution for Subcutaneous Use--WarningsPrecautionsAdverse Reactions---
Fosrenol (lanthanum carbonate) Chewable Tablets and Oral Powder --WarningsPrecautionsAdverse Reactions---
Invirase (saquinavir mesylate) Capsules and Tablets --WarningsPrecautions----
Tecfidera (dimethyl fumarate)--WarningsPrecautions----
Atacand HCT (candesartan cilexetil/hydrochlorothiazide)---Precautions----
Drug Name BW C W P AR PPI MG PCI
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets---Precautions----
Complera (emtricitabine/rilpivirine/tenofovir disoproxil fumarate) Tablets---PrecautionsAdverse Reactions---
Depakene (valproic acid) CapsulesDepakene (valproic acid) Oral Solution Depakote (divalproex sodium) Delayed Release TabletsDepakote Sprinkle CapsulesDepacon (valproate sodium) InjectionDepakote ER (divalproex sodium) Extended Release Tablets---PrecautionsAdverse Reactions---
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) Tablets---Precautions----
Truvada (emtricitabine/tenofovir disoproxil fumarate) Tablets---PrecautionsAdverse Reactions---
Anoro Ellipta (umeclidinium and vilanterol inhalation powder), for Oral Inhalation----Adverse Reactions---
Breo Ellipta (fluticasone furoate/vilanterol) Inhalation Powder----Adverse Reactions---
Effexor XR (venlafaxine Extended-Release) Capsules----Adverse Reactions---
Opsumit (macitentan) Tablets----Adverse Reactions---
Simponi Aria (golimumab) Injection----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Zostavax (Zoster Vaccine, Live)----Adverse Reactions---