MedWatch March 2013 Safety Labeling Changes

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The MedWatch March 2013 Safety Labeling Changes posting includes 53 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/ucm346535.htm

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

Brilinta (ticagrelor)
Carafate (sucralfate)
Carafate (sucralfate)
Wellbutrin (bupropion hydrochloride) and Wellbutrin SR 
Anaprox, Anaprox DS (naproxen sodium tablets)
Avastin (bevacizumab)
Clozaril (clozapine)
Coly-Mycin M Parenteral Solution (colistimethate sodium, USP)    
EC-Naprosyn (naproxen delayed-release tablets)
Erbitux (cetuximab) 
Firmagon (degarelix for injection)
Geodon (ziprasidone HCl)
Geodon (ziprasidone mesylate)
Humalog (insulin lispro [rDNA origin] injection)
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro [rDNA origin] injection)
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro [rDNA origin] injection)
INOmax (nitric oxide) for Inhalation
Levemir (insulin detemir [rDNA origin] injection)
Lopressor (metoprolol tartrate) Tablets
Lopressor (metoprolol tartrate) injection
Maxipime (cefepime hydrochloride, USP) for Injection
Merrem I.V. (meropenem for injection)
Naglazyme (galsulfase)
Naprosyn (naproxen tablets) 
NovoLog (insulin aspart [rDNA origin] injection)
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin] injection)
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin] injection)
Remicade (infliximab)
Rythmol (propafenone HCl)
Silvadene (silver sulfadiazine)
Tegretol (carbamazepine) and Tegretol-XR (carbamazepine extended-release)
Vectibix (panitumumab)
Arthrotec (diclofenac sodium/misoprostol)
Carbatrol (carbamazepine)
Cerebyx (fosphenytoin sodium)
Dilantin-125 (phenytoin)
Dilantin (phenytoin sodium, USP)
Toradol (ketorolac tromethamine)
Visicol (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP)

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