Drug Safety Labeling Changes - February  2016

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Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

  • C - Contraindications
  • W - Warnings
  • P - Precautions
  • AR - Adverse Reactions

Drug Name Sections Modified
C W P AR
Emtricitabine/ Tenofovir Tablets
- -
Irbesartan/ Hydrochlorothiazide - Tablets -
Candesartan - Tablets - -
Candesartan /Hydrochlorothiazide - - -
Certolizumab - Lyophilized Powder and Solution for Subcutaneous Use -
Dimethyl fumarate - -
Efavirenz/ Emtricitabine/ Tenofovir -Tablets - - -
Elvitegravir/ Cobicistat/ Emtricitabine/Tenofovir - Tablets - - -
Emtricitabine/Rilpivirine/ Tenofovir - Tablets - -
Fingolimod - Capsules -
Fluorescein - Injection
Fluticasone furoate/ Vilanterol - Inhalation Powder - - -
Golimumab - Injection - - -
Hydroxyzine - Capsules and Oral Suspension -
Lanthanum Carbonate - Chewable Tablets and Oral Powder -
Macitentan - Tablets - - -
Saquinavir - Capsules and Tablets - -
Umeclidinium and Vilanterol - Inhalation Powder, for Oral Inhalation - - -
Valproic acid - Capsules
Valproic acid - Oral Solution
Divalproex sodium - Delayed Release Tablets
Depakote Sprinkle Capsules
Depacon (valproate sodium) - Injection
Depakote ER (divalproex sodium) - Extended Release Tablets
- -
Venlafaxine - Extended-Release Capsules - - -
Zoster Vaccine, Live - - -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

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