Drug Safety Labeling Changes - August  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
Eribulin Mesylate Injection For Intravenous Administration - - -
Hydrocodone - Extended-Release Capsules, for Oral Use, CII -
Paricalcitol - Capsules -
Valproic acid - Delayed Release Capsules, for Oral Use - -
Adenosine - Injection, for Intravenous Use -
Almotriptan - Tablets for Oral Use -
Apixaban - Tablets for Oral Use - -
Aprepitant - Capsules - - -
Axitinib -Tablets for Oral Administration - -
Bevacizumab - Solution for Intravenous Infusion - - -
Bupropion - Sustained-Release Tablets, for Oral Use -
Dabigatran - capsules for Oral Use - - -
Dapagliflozin -Tablets, 5 mg and 10 mg - - -
Diclofenac - Capsules - - - -
Estradiol - Vaginal Ring -
Etravirine - 200 mg, 100 mg, and 25 mg tablets - - -
Fosaprepitant Dimeglumine for Injection - - -
Ifosfamide - for Injection - - -
Lacosamide -Tablet, Film Coated for Oral use, CV
Lacosamide) Injection for Intravenous use, CV
Lacosamide - Oral Solution, CV
- - -
Levetiracetam - Extended-Release Tablets, for Oral Use -
Levetiracetam - Injection for Intravenous Use - - -
Levetiracetam - Tablets, for Oral Use
Levetiracetam - Oral Solution
- - -
Lomitapide - Capsules, for Oral Use - - -
Nicotine - polacrilex Gum - - -
Panitumumab - Injection for Intravenous Infusion -
Peginterferon alfa-2b for Injection, for Subcutaneous Use - - -
Pioglitazone and Metformin Hydrochloride - Tablets for Oral Use - - - -
Radiogardase (Prussian Blue Insoluble) capsules, for oral use -
Ropinirole - Tablet, Extended Release for Oral Use -
Somatropin [rDNA origin] injection), for Subcutaneous use - -
Taliglucerase alfa - for injection, for intravenous use -
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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