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March 2013 Medication Safety Labeling Changes

Last month brought changes to fifty-three (53) medical product labels (way up from 35 changes in February), with changes to the prescribing information to include any of the following areas: boxed warnings, contraindications, warnings, precautions, adverse reactions, patient package insert, and medication guide.

For a complete detailed accounting of the label changes, refer to the summary of meds. By clicking onto the drug name, you will be able to view the detailed summary, which will identify the safety labeling section and revised subsection, as well as a brief summary of the new or modified safety information.

The following medications have been affected:

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)

There is drug on this list involved in a mass tort that I am aware of other than Dilantin which has seen some cases filed around the country.  The best cases allege Stevens-Johnson Syndrome.

 

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