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Drug Safety Labeling Changes - May 2014

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
Irbesartan
Levofloxacin - Tablets, Injection, and Oral Solution
Linagliptin - Tablets
Linagliptin and Metformin Hydrochloride - Tablets
Omacetaxine Mepesuccinate - for Injection
Palonosetron - Injection
Quinapril - Tablets
Ramipril - Capsules
Rasagiline - Tablet
Rilpivirine - 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