Drug Safety Labeling Changes - July  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
Acetaminophen and Caffeine - Tablets, Caplets and Geltabs - - -
Azilsartan Medoxomil - Tablets - - -
Azilsartan Medoxomil/ Chlorthalidone - Tablets - - -
Desvenlafaxine - Extended-Release Tablets -
Fluoxetine - Pulvules -
Nexplanon - Etonogestrel implant, Radiopaque, Subdermal Use Only - - -
Paroxetine - Tablets, Oral Suspension and Controlled-Release Tablets -
Protriptyline - Tablets -
Triamcinolone Acetonide Injectable Suspension - - -
Ado-Trastuzumab Emtansine for Injection, for Intravenous Use -
Amlodipine and Olmesartan Medoxomil - Tablets, for oral use - - -
Betamethasone and Betamethasone Acetate Injection Suspension - - -
Boceprevir - Capsules - -
Bupropion - Extended-Release Tablets -
Bupropion - Sustained-Release Tablets -
Calcitonin-salmon [rDNA origin]) Nasal Spray for Intranasal Use -
Citalopram - Tablets -
Clarithromycin - tablets, USP
Clarithromycin - for Oral Suspension USP)
Clarithromycin - extended release tablets
- - -
Clomipramine - Capsules -
Desipramine -Tablets USP -
Desvenlafaxine - Extended-Release Tablets -
Desvenlafaxine - Extended-Release Tablets -
Desvenlafaxine - Extended-Release Tablets -
Dexamethasone - Phosphate Injection - - -
Dextroamphetamine mixed salts of a single entity amphetamine product Capsules - - -
Docetaxel - Injection -
Doxepin - Capsules and Oral Concentrate -
Duloxetine - Capsules -
Eprosartan - - -
Eprosartan /Hydrochlorothiazide - Tablets - - -
Escitalopram -Tablets and Oral Solution -
Everolimus - Tablets for Oral Administration -
Everolimus - Tablets for Oral Suspension -
Fluoxetine - Delayed Release Capsules -
Fluoxetine - Tablets -
Fluvoxamine - Extended-Release Capsules -
Fluvoxamine -Tablets -
Fondaparinux - Solution for Injection - -
Histrelin Acetate - Subcutaneous Implant - -
Humatrope (somatropin [rDNA origin] for injection) - -
Hydrocortisone - Injection and Sterile Powder for Injection - - -
Imipramine - Capsules -
Implanon - Etonogestrel Implant, For Subdermal Use - - -
Indinavir - - -
Leuprolide - Injection - - -
Levomilnacipran - Extended- Release Capsules -
Linaclotide - Capsules -
Memantine - Extended-Release Capsules - - -
Methylprednisolone - Injectable Suspension, USP - - -
MethylPrednisolone - Sterile Powder for Injection - - -
Mirtazapine - Tablets Orally Disintegrating Tablets -
Nicardipine - Injection - - -
Nortriptyline - Solution
Nortriptyline Capsules
-
Olanzapine and Fluoxetine - Capsules -
Oxcarbazepine - Film-Coated Tablets and Oral Suspension for Oral Administration - -
Paroxetine - Tablets -
Rosuvastatin - Tablets - - -
Ruxolitinib - Tablets - -
Selegiline - Orally Disintegrating Tablets - -
Sertraline - Tablets and Oral Concentrate -
Tamsulosin - Capsules -
Trazodone - Extended-Release Tablets -
Trazodone - Tablets -
Triamcinolone - USP Injectable Suspension - - -
Triamcinolone Hexacetonide - Injection Suspension - - -
Trimipramine - Capsules -
Triptorelin - for Injectable Suspension Intramuscular use - -
Venlafaxine - Extended-Release Capsules -
Venlafaxine - Extended-Release Tablets -
Venlafaxine -Extended-Release Tablets - - -
Vilazodone - Tablets -
Vortioxetine - 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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