October 2012 Safety Labeling Changes

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The MedWatch October 2012 Safety Labeling Changes posting includes 58 products with safety labeling changes to the following sections: 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/ucm326133.htm

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

  • Aciphex (rabeprazole sodium)
  • Actemra (tocilizumab)
  • Advicor (niacin ER/lovastatin)   
  • Alimta (pemetrexed for injection)   
  • Altoprev (lovastatin) 
  • Anafranil (clomipramine)    
  • Avalide (irbesartan/hydrochlorothiazide)  
  • Caduet (amlodipine/atorvastatin)
  • Cimzia (certolizumab pegol) 
  • Clomid (clomiphene citrate)
  • Combigan (brimonidine tartrate/timolol maleate)
  • Crestor (rosuvastatin calcium)
  • Cymbalta (duloxetine hydrochloride)    
  • Diovan (valsartan) and Diovan HCT (valsartan/hydrochlorothiazide)   
  • Edarbi (azilsartan medoxomil)
  • Edarbyclor (azilsartan medoxomil/chlorthalidone)
  • Fenoglide (fenofibrate)
  • Gelnique (oxybutynin chloride)
  • Juvisync (sitagliptin/simvastatin)
  • Lescol XL (fluvastatin sodium)
  • Letairis (ambrisentan)
  • Lipitor (atorvastatin calcium)  
  • Livalo (pitavastatin)
  • Lotrel (amlodipine besylate and benazepril hydrochloride)  
  • Mevacor (lovastatin) 
  • Micardis (telmisartan) and Micardis HCT (telmisartan/hydrochlorothiazide)    
  • Nexium I.V. (esomeprazole sodium)  
  • Nexium (esomeprazole magnesium)  
  • Oxytrol (oxybutynin)    
  • Pravachol (pravastatin sodium)
  • Prilosec (omeprazole)
  • Protonix (pantoprazole sodium)
  • Protonix I.V. (pantoprazole sodium)
  • Pamelor (nortriptyline HCl)    
  • Remeron and Remeron SolTab (mirtazapine)
  • Simcor (Niacin ER/Simvastatin)
  • Tofranil-PM (imipramine pamoate) 
  • Topamax (Topiramate)
  • Tracleer (Bosentan)    
  • Twynsta (Telmisartan/Amlodipine)   
  • Vimovo (naproxen/esomeprazole magnesium)   
  • Vytorin (ezetimibe/simvastatin)
  • Zocor (simvastatin)
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