Drug Safety Labeling Changes - APRIL  2013

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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
Histrelin Acetate - Subcutaneous Implant - - -
(Liraglutide [rDNA orgin]) Injection - -
Adapalene - lotion - - -
Alendronate - Effervescent Tablets - -
Alendronate - Tablets and Oral Solution - -
Alendronate / Cholecalciferol - Tablets - -
Artemether/Lumefantrine - -
Belatacept - Intravenous Injection - -
Benztropine - Injection - - -
Candesartan - Tablets
Candesartan Cilexetil Hydrochlorothiazide Tablets
Cyclobenzaprine Hydrochloride Extended Release Capsules - -
Cyclobenzaprine -Tablets -
Dabigatran - Capsules -
Doripenem - for Injection - - -
Dutasteride and Tamsulosin - Capsules
Dutasteride Gelatin Capsules - - -
Efavirenz,Emtricitabine,Tenofovir, Disoproxil Fumarate - -
Emtricitabine - Capsulests and Oral Solution - -
Etidronate - Tablets - -
Famicyclovir -Tablets - - -
Fidaxomicin - Tablets -
Golimumab - Injection - -
Histrelin Acetate - Subcutaneous Implant -
Ibandronate - Injection
Ibandronate - Tablets - -
Incobotulinumtoxin A for Injection - - -
Interferon Beta 1-a Injection - - -
Lacosamide - Tablets, Injection and Oral Solution - - -
Laronidase - solution for intravenous infusion - - -
Lomitapide - Capsules - -
Pancrelipase - Delayed - Release Capsules - - -
Quetiapine- Extended Release Tablets - -
Quetiapine -Tablets - -
Quinine - Capsules - -
Risedronate - Tablets - -
Risedronate Sodium Delayed Release Tablets - -
Risedronate with Calcium Carbonate Tablets - -
Telaprevir - Film Coated Tablets - -
Tenefovir - Tablets and Oral Powder - -
Tocilizumab Injection - -
Tolvapatan - Tablets -
Treprostinil - Inhalation Solution - - -
Ustekinumab - Injection - - -
Zaleplon -Capsules - - -
Zolpidem - Sublingual Tablets - -
Zolpidem - Tablets
Zolpidem- Extended Release Tablets

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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