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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:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/ucm323036.htm
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)
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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