Drug Safety Labeling Changes - March 2013

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March 2013

This monthly summary of drug label changes provides a quick view of the sections that have changed. Click on a drug name to view the changes in more detail.

Key to Label Sections
BW - Boxed Warning C - Contraindications W - Warnings P - Precautions
AR - Adverse Reactions PPI - Patient Package Insert MG - Medication Guide PCI - Patient Counseling Information

Sections Modified
Drug Name BW C W P AR PPI MG PCI
Carafate (sucralfate) Suspension-Contraindications--Adverse Reactions---
Carafate (sucralfate) Tablets-Contraindications-PrecautionsAdverse Reactions---
Wellbutrin (bupropion hydrochloride) Tablets and Wellbutrin SR (bupropion hydrochloride) Sustained-Release Tablets-Contraindications--Adverse Reactions---
Anaprox, Anaprox DS (naproxen sodium tablets)--Warnings-----
Coly-Mycin M Parenteral Solution (colistimethate sodium, USP)--Warnings-----
EC-Naprosyn (naproxen delayed-release tablets)--Warnings-----
Erbitux (cetuximab)--WarningsPrecautionsAdverse Reactions---
Geodon (ziprasidone HCl) Capsules and Oral Suspension Geodon (ziprasidone mesylate) Injection--WarningsPrecautions----
Humalog (insulin lispro [rDNA origin] injection)--WarningsPrecautions-Patient Package Insert--
Humalog Mix 50/50 (50% insulin lispro protamine suspension/50% insulin lispro [rDNA origin] injection)--WarningsPrecautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
Humalog Mix 75/25 (75% insulin lispro protamine suspension/25% insulin lispro [rDNA origin] injection)--WarningsPrecautions-Patient Package Insert--
INOmax (nitric oxide) for Inhalation --WarningsPrecautionsAdverse Reactions---
Levemir (insulin detemir [rDNA origin] injection) --WarningsPrecautions-Patient Package Insert--
Lopressor (metoprolol tartrate) 50 mg / 100 mg TabletsLopressor (metoprolol tartrate) 5 mg / 5 ml injection--WarningsPrecautions----
Maxipime (cefepime hydrochloride, USP) for Injection--WarningsPrecautionsAdverse Reactions---
Merrem I.V. (meropenem for injection)--WarningsPrecautions----
Naglazyme (galsulfase)--WarningsPrecautions----
Naprosyn (naproxen tablets)--Warnings-----
NovoLog (insulin aspart [rDNA origin] injection) --WarningsPrecautions-Patient Package Insert--
NovoLog Mix 50/50 (50% insulin aspart protamine suspension and 50% insulin aspart [rDNA origin] injection)--WarningsPrecautions-Patient Package Insert--
Drug Name BW C W P AR PPI MG PCI
NovoLog Mix 70/30 (70% insulin aspart protamine suspension and 30% insulin aspart [rDNA origin] injection)--WarningsPrecautions-Patient Package Insert--
Remicade (infliximab)--WarningsPrecautionsAdverse Reactions---
Rythmol (propafenone HCl) Tablets--WarningsPrecautions----
Silvadene (silver sulfadiazine) Cream--Warnings-----
Tegretol (carbamazepine) Tablets, Chewable Tablets, Oral Suspension, and Tegretol-XR (carbamazepine extended-release) Tablets--WarningsPrecautions----
Vectibix (panitumumab) --WarningsPrecautions----
Arthrotec (diclofenac sodium/misoprostol) Oral Tablets---Precautions----
Carbatrol (carbamazepine) Extended Release Capsules---PrecautionsAdverse Reactions---
Cerebyx (fosphenytoin sodium) Injection---Precautions----
Dilantin-125 (phenytoin) Oral Suspension---Precautions----
Drug Name BW C W P AR PPI MG PCI
Dilantin (phenytoin sodium, USP) Injection---Precautions----
Toradol (ketorolac tromethamine) Oral Tablets---Precautions----
Visicol (sodium phosphate monobasic monohydrate, USP and sodium phosphate dibasic anhydrous, USP) Tablets---Precautions----
ADDERALL XR (dextroamphetamine mixed salts of a single-entity amphetamine product) Capsules----Adverse Reactions---
Mirapex (pramipexole dihydrochloride) Tablets and Mirapex ER (pramipexole dihydrochloride) Extended Release Tablets----Adverse Reactions---
Multaq (dronedarone hydrochloride) Tablets----Adverse Reactions---
Rapamune (sirolimus) Oral Solution and Tablets----Adverse Reactions---
Saphris (asenapine) Sublingual Tablets----Adverse Reactions---
Trelstar (triptorelin pamoate for injectable suspension)----Adverse Reactions---
Voraxaze (glucarpidase)----Adverse Reactions---
Drug Name BW C W P AR PPI MG PCI
Cozaar (losartan potassium) Tablets --------
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)-----Patient Package Insert--
Humulin N NPH (human insulin isophane suspension [rNDA origin])-----Patient Package Insert--
Humulin R (insulin human injection, USP [rDNA origin])-----Patient Package Insert--
Hyzaar (losartan potassium/HCTZ) Tablets--------
Novolin 70/30 (70% NPH, human insulin isophane suspension and 30% regular human insulin [rDNA origin]) Injection -----Patient Package Insert--
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection -----Patient Package Insert--
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