Drug Safety Labeling Changes - AUGUST  2013

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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 - - -
Levofloxacin - Tablets, Oral Solution and Injection -
Peg-3350 & electrolytes For oral solution -
Roflumilast - Tablets - -
Ambrisentan - Tablets
Atazanavir Sulfate Capsules - - -
Atomoxetine - Capsules -
Bedaquiline - Tablets - - - -
Ciprofloxacin - Extended-Release Tablets -
Ciprofloxacin - Tablets and Oral Suspension -
Ciprofloxacin - Tablets and Oral Suspension -
Degarelix - for Injection - - -
Denosumab - Injection -
Doxorubicin - Liposome Injection -
Flunisolide - Inhalation Aerosol - - -
Gadodiamide - Injection - - -
Gadofosveset Trisodium Injection - -
Gadoversetamide - Injection - - -
Gemifloxacin - Tablets - - -
Glimepiride - Tablets - - -
Guanfacine - Extended-release Tablets - - -
Ibritumomab Tiuxetan - Injection - -
Levonorgestrel-Releasing Intrauterine System - -
Levonorgestrel-Releasing Intrauterine System - -
Mesalamine - Delayed-Release Tablets - - -
Methamphetamine - Tablets - -
Methylnaltrexone Bromide - Subcutaneous Injection - -
Methylphenidate - Extended-release Oral Suspension - -
Moxifloxacin - Tablets and Injection -
Norfloxacin - Tablets -
Pazopanib -Tablets - -
Rivaroxaban - Tablets -
Rosuvastatin - Tablets -
Sunitinib Malate 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

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