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Drug Safety Labeling Changes - OCTOBER 2013

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
Glyburide - Tablets
Glyburide - Tablets
Vigabatrin - Tablet and Powder for Oral Solution
Alvimopan Capsules
Anakinra - for Injection
Crizotinib - Capsules
Deferasirox - Tablets, for oral suspension
Diazepam -Tablets
Doxycycline - Capsules
Enoxaparin - Injection
Estradiol - Transdermal System
Gadobutrol - Injection
Gadoxetate Disodium Injection
Gemfibrozil - Capsules
Glimepiride - Tablets
Glipizide - Extended Release tablets
Glipizide - Tablets
Glyburide -Tablets
Imatinib - Tablets
Ketoconazole - 2% Shampoo
Memantine - Tablets
Naltrexone - tablets
Naratriptan - Tablets
Ondansetron -Oral Soluble Film
Orlistat - Capsules
Pitavastatin - Tablets
Quetiapine - Extended-Release Tablet
Quetiapine - Tablets
Quinapril - Tablets
Raltegravir - Film-Coated Tablets and Chewable Tablets
Ramipril - Capsules
Rivastigmine - Capsules and Oral Solution
Simvastatin - Tablets
Solifenacin -Tablets
Sorafenib - Tablets
Tapentadol - Immediate-Release Tablets
Telaprevir - Tablets
Tocilizumab Injection
Tranexamic acid -Tablets
Valsartan - Capsules

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

Drugs A-Z
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