Drug Safety Labeling Changes - June  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
Olmesartan Medoxomil-Hydrochlorothiazide Tablets - -
Somatropin [rDNA origin] for Injection - -
Somatropin [rDNA origin]) for Injection - - -
Alprostadil - for Injection - - -
Amlodipine and Olmesartan Medoxomil - Tablets, for oral use - - -
Caverject Impulse Dual Chamber System (alprostadil for injection) - - -
Clindamycin - Capsules -
Clindamycin - injection, USP and Clindamycin - injection in 5 percent dextrose -
Denosumab - Injection for Subcutaneous Use - -
Denosumab Injection - -
Emtricitabine, Rilpivirine, Tenofovir -Tablets, for Oral Use - -
Entacapone - Tablets - - -
Etonogestrel/Ethinyl Estradiol Vaginal Ring - - -
Fosphenytoin - Injection - - -
Gattex (teduglutide [rDNA origin]) for Subcutaneous Injection - - -
Glycerol Phenylbutyrate - Oral Liquid - - -
Hydroxyzine - Capsules and Oral Suspension - - -
Increlex (mecasermin [rDNA origin]) injection - - -
Irbesartan and Hydrochlorothiazide -Tablets - -
Itraconazole - Capsules
Itraconazole - Oral Solution
Lamotrigine -Tablets
Lamotrigine - Chewable Dispersible Tablets
Lamotrigine - Orally Disintegrating Tablets
Lamotrigine - Extended-Release Tablets
- - - -
Leuprolide acetate - for Depot Suspension - -
Lisinopril - Tablets -
Norethindrone - Tablets - - -
Obinutuzumab - Injection - -
Ocriplasmin - Intravitreal Injection, 2.5 mg/mL - - -
Olmesartan Medoxomil - Tablets, for Oral Use - -
Olmesartan Medoxomil, Amlodipine, Hydrochlorothiazide - Tablets - -
Orlistat - Capsules - - - -
Oxcarbazepine - Film-Coated Tablets and Oral Suspension - -
Pazopanib - Tablets - - -
Pegademase Bovine - Injection - - -
Pramlintide Acetate Injection -
Somatropin [rDNA origin]) for Injection - -
Somatropin [rDNA origin]) for Injection - -
Sumatriptan - Injection -
Sunitinib - capsules, oral - -
Testim Testosterone Gel - -
Testosterone - Buccal System - -
Testosterone - gel - -
Testosterone - Gel 1% and 1.62% - -
Testosterone - Injection - -
Testosterone - Topical Solution - -
Testosterone - Transdermal System - -
Testosterone Enanthate - Injection - -
Testosterone Gel - -
Thalidomide - Capsules - -
Topotecan - Capsules - - -
Trastuzumab - Intravenous Infusion -
Ulipristal Acetate - Tablet - -
Valproic acid - Capsules
Valproic acid - Oral Solution
Divalproex Sodium Delayed Release
Divalproex sodium coated particles in capsules
Valproate - Injection
Divalproex sodium 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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