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September 2012 Medication Label Changes

Last month brought changes to sixty (60) medical product labels(up from 53 changes in August), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, please refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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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