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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)
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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