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Reference Desk April 2013

FDA Safety Labeling Changes

    April 15, 2013 — 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.

    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)

    Source: FDA


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