Drug Safety Labeling Changes - September  2012

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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
- - - -
Abiraterone acetate - - -
Aggrenox (aspirin/extended release dipyridamole) 25 mg/200 mg Capsules -
Albuterol (Salbutamol) - - -
Amlodipine , Hydrochlorothiazide and Olmesartan - - - -
Amlodipine and Olmesartan - -
Amlodipine and Valsartan
Amlodipine, Valsartan and Hydrochlorothiazide
Benazepril - -
Benazepril HCl and Hydrochlorothiazide - -
Cayston (aztreonam for inhalation solution) - - - -
Cefepime -
Clobetasol Propinate - - - -
Deferasirox
Denosumab - - - -
Dexlansoprazole - - - -
Doxorubicin - - -
Dronedarone - - - -
Enalapril - - - -
Enalapril and Hydrochlorothiazide - - - -
Eprosartan - - - -
Eprosartan Mesylate Hydrochlorothiazide - - - -
Esomeprazole -
Fenofibric Acid -
Formoterol - - - -
Indacaterol
Irbesartan - -
Lansoprazole - - - -
Levalbuterol HCl - - -
Levocetirizine - -
Linagliptin - - -
Losartan - -
Lovaza (omega 3-acid ethyl esters) Capsules -
Miglitol - - - -
Moexipril HCl Hydrochlorothiazide Tablets - - - -
Montelukast - - -
Mycophenolatemofetil - - - -
Naproxen and Esomeprazole Magnesium -
Olmesartan - -
Omeprazole - - - -
Ozurdex (dexamethasone intravitreal implant) 0.7 mg
Paclitaxel - - - -
Pantoprazole - - - -
Quinapril - -
Quinapril HC- Hydrochlorothiazide Tablets - -
Rotavirus vaccine - - - -
Simvastatin and Sitagliptin
Telmisartan - - - -
Testosterone Fortesta - - - -
Trandolapril - - - -
Trandolapril- Verapamil - -
Voltaren Opthalmic (diclofenac sodium ophthalmic solution) 0.1% - -
Zolmitriptan -

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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