Drug Safety Labeling Changes - May  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
Eszopiclone - Tablets - -
Abiraterone Acetate - Tablets - - -
Acitretin - Capsules -
Adalimumab - - -
Adalimumab - - -
Anastrozole -Tablets - - - -
Canagliflozin -Tablets - - -
Clindamycin - Vaginal Cream
Clindamycin - Vaginal Suppositories and Vaginal Ovules
- - -
Colestipol - Granules and Tablets - - -
Crizotinib - Capsules - - -
Dolutegravir -Tablets - - -
Dopamine - injection
Dopamine and 5% Dextrose injection
- - -
Efavirenz - Capsules and Tablets - -
Etonogestrel - Implants - - -
Etonogestrel - Implants - - -
Exemestane - Oral Tablets -
Exenatide - Extended-Release for Injectable Suspension -
Gemcitabine - for Injection -
Imatinib - Tablets - - -
Insulin Glulisine [rDNA origin]) Injection - -
Irbesartan - - -
Irbesartan/ Hydrochlorothiazide - - -
Levofloxacin - Tablets, Injection, and Oral Solution - - -
Linagliptin - Tablets
Linagliptin and Metformin Hydrochloride - Tablets
Lumizyme Alglucosidase Alfa - - -
Myozyme Alglucosidase Alfa - - -
Omacetaxine Mepesuccinate - for Injection - - - -
Palonosetron - Injection - - -
Quinapril - Tablets - -
Quinapril and Hydrochlorothiazide - Tablets - -
Ramipril - Capsules - -
Rasagiline - Tablet - -
Rilpivirine - Tablets -
Riociguat - Tablets - - -
Rosiglitazone - Tablets
Rosiglitazone and Glimepiride - Tablets
Rosiglitazone and Metformin Hydrochloride - Tablets
- - -
Temozolomide - for Injection
Temozolomide - 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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