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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)
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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