Drug Safety Labeling Changes - October  2014

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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
Capecitabine - Tablets - -
Fluconazole - Tablets and Powder for Oral Suspension - - -
Romidepsin - lyophilized powder - -
Aflibercept - Injection - -
Anagrelide - Capsules - -
Asenapine - Sublingual Tablets - -
Bortezomib - for Injection - -
BreathID System 13C-Urea Breath Test - -
Canakinumab - -
Caspofungin - Injection  - - -
Ciclesonide - Nasal Aerosol - -
Docetaxel - Injection - -
Duloxetine - Capsules - - - -
Etonogestrel/Ethinyl Estradiol Vaginal Ring - - - -
Goserelin - Implant - -
Isosorbide Dinitrate - Sustained Release Tablets - -
Isosorbide Mononitrate - Tablets - -
Leuprolide - for Injectable Suspension - -
Levetiracetam - Injection - -
Lincomycin - Injection, USP Sterile Solution - -
Mesalamine - Delayed-Release Tablets - - -
Methoxy Polyethylene Glycol-Epoetin Beta -
Metoprolol Succinate - Extended Release/Hydrochlorothiazide Tablets
Minocycline - for Injection Intravenous - - -
Naftifine - Gel, Cream - - -
Nitroglycerin - 5 Percent in Dextrose for Injection - -
Nitroglycerin - Transdermal Infusion System - -
Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use -
Rabeprazole - Delayed-Release Tablets - - -
Spironolactone - Tablets - - -
Spironolactone/Hydrochlorothiazide - Tablets - - -
Tamsulosin - Capsules - - -
Teriflunomide - -
Topiramate - Sprinkle Capsules - - -
Varenicline - Tablets  - - -
Xiaflex (Collagenase Clostridium histolyticum)
Zolpidem - -

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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