FDA MedWatch - March 2014 Drug Safety Labeling Changes includes 30 products with revisions to Prescribing Information

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FDA MedWatch - March 2014 Drug Safety Labeling Changes includes 30 products with revisions to Prescribing Information

The MedWatch March 2014 Safety Labeling Changes posting includes 30 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 product names and safety labeling sections revised:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm392205.htm

The following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS and PRECAUTIONS sections:

Stavzor (Valproic acid)  
Xarelto (rivaroxaban)  
Diflucan (fluconazole)    
Evamist (estradiol transdermal spray)
Sodium Iodide I-131 Therapeutic Solution
Azulfidine (sulfasalazine tablets, USP)
Erwinaze (asparaginase Erwinia chrysanthemi)
Herceptin (trastuzumab)    
Jevtana (cabazitaxel) 
Miacalcin (calcitonin-salmon)   
Nexium (esomeprazole sodium)
Prilosec (omeprazole)
Selzentry (maraviroc)
Revatio (sildenafil)
Ultane (sevoflurane), Ultane NovaPlus (sevoflurane)
Viagra (sildenafil citrate)
Vimovo (naproxen/esomeprazole magnesium)
Xeljanz (tofacitinib)
Xifaxan (rifaximin)


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