September 2012 Safety Labeling Changes


The MedWatch September 2012 Safety Labeling Changes posting includes 60 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The “Summary Page” provides a listing of drug names and safety labeling sections revised:

The following drugs had modifications to the BOXED WARNINGS, CONTRAINDICATIONS and/or WARNINGS sections:

  • Exjade (deferasirox)
  • Accupril (quinapril hydrochloride)
  • Accuretic (quinapril HCL/hydrochlorothiazide)
  • Arcapta Neohaler (indacaterol maleate)
  • Avapro (irbesartan)
  • Azor (amlodipine/olmesartan medoxomil)
  • Benicar (olmesartan medoxomil)
  • Benicar HCT (olmesartan medoxomil/hydrochlorothiazide)
  • Cozaar (losartan potassium)
  • Doxil (doxorubicin HCl liposome injection)
  • Exforge (amlodipine/valsartan)
  • Exforge HCT (amlodipine/valsartan/hydrochlorothiazide)
  • Hyzaar (losartan potassium/HCTZ)  
  • Juvisync (sitagliptin/simvastatin)
  • Lotensin (benazepril HCl)
  • Lotensin HCT (benazepril HCl and hydrochlorothiazide)  
  • Mavik (trandolapril)  
  • Multaq (dronedarone hydrochloride)
  • Ozurdex (dexamethasone intravitreal implant)
  • Tarka (trandolapril/verapamil hydrochloride)
  • Teveten (Eprosartan Mesylate)
  • Teveten HCT (eprosartan mesylate hydrochlorothiazide)
  • Tribenzor (olmesartan medoxomil amlodipine/hydrochlorothiazide)
  • Uniretic (moexipril hydrochloride/hydrochlorothiazide)
  • Vaseretic (enalapril maleate/hydrochlorothiazide)
  • Vasotec (enalapril maleate)
  • Univasc (moexipril hydrochloride)
  • Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)
  • Aggrenox (aspirin/extended release dipyridamole)
  • Cefepime for Injection 
  • Dexilant (dexlansoprazole)
  • Foradil Aerolizer (formoterol fumarate inhalation powder)
  • Lovaza (omega 3-acid ethyl esters)
  • Maxipime (cefepime hydrochloride)
  • Nexium (esomeprazole magnesium)
  • Nexium I.V. (esomeprazole sodium)
  • Prevacid (lansoprazole)
  • Prilosec (omeprazole)
  • Protonix (pantoprazole sodium)
  • Trilipix (fenofibric acid)
  • Vimovo (naproxen/esomeprazole magnesium)
  • Xgeva (denosumab)
  • Xyzal (levocetirizine dihydrochloride)
  • Zomig (zolmitriptan)
  • Zomig-ZMT (zolmitriptan)
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