MedWatch May 2013 Safety Labeling Change

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The MedWatch May 2013 Safety Labeling Changes posting includes 40 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/ucm355680.htm

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

Codeine Sulfate Solution
Codeine Sulfate Tablets
Fioricet with Codeine (butalbital, acetaminophen, caffeine, and codeine phosphate) Capsules
Fiorinal with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) Capsules
Promethazine and Codeine Syrup   
Promethazine, Phenylephrine and Codeine Syrup
Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate) Tablets   
SynalgosDC (dihydrocodeine bitartrate, aspirin and caffeine) Capsules
Vivelle-Dot (estradiol transdermal system)
Kombiglyze XR (saxagliptin + metformin XR FDC) tablets
Onglyza (saxagliptin)
Dyna-Hex 0.75 (chlorhexidine gluconate 0.75% solution)    
Gemzar (Gemcitabine for injection), 1g and 200 mg
Humira (adalimumab)
Inspra (eplerenone) 25 mg and 50 mg Tablets 
Magnesium Sulfate in dextrose 5 percent injection, USP   
Magnesium Sulfate Injection, USP, 50 percent 
Magnesium Sulfate in Water for Injection, USP, in Flexible Plastic Container   
Neoral Soft Gelatin Capsules (cyclosporine capsules, USP)
Neoral Oral Solution (cyclosporine oral solution, USP) 
Rituxan (rituximab)  
Sandimmune Injection (schizophrenics USP)
Sandimmune Oral Solution (cyclosporine USP)
Sandimmune Soft Gelatin Capsules (cyclosporine USP)  
Tasmar (tolcapone) 100 mg Tablets
Tysabri (Natalizumab) injection
Yervoy (ipilimumab)

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