Drug Safety Labeling Changes - MARCH 2013

Creator: Madhumathi Palaniappan
Keywords: FDA label changes MARCH - 2013, Drug Name, Sections Modified, Contraindications, Precautions, Adverse Reactions

Written & Compiled by - Madhumathi Palaniappan

Medically Reviewed by - The Medindia Medical Review Team

Food and Drug Administration (FDA) announces important safety label changes for prescription drugs almost every month. By implementing the label changes the FDA warns a physician of new side- effects, adverse reactions, contra-indications and precautions necessary for a drug. This information is important for safe practice of medicine.

Key to Label Sections

C - Contraindications
W - Warnings
P - Precautions
AR - Adverse Reactions

Drug Name	Sections Modified
Drug Name	C	W	P	AR
Dextroamphetamine mixed salts of a single-entity amphetamine product Capsules	-	-	-
Losartan /HCTZ Tablets	-	-	-	-
Asenapine - Sublingual Tablets	-	-	-
Bevacizumab	-
Bupropion - Sustained Release Tablets		-	-
Bupropion -Tablets		-	-
Carbamazepine - Extended Release Tablets	-			-
Carbamazepine - Tablets	-			-
Carbamazepine- Chewable Tablets	-			-
Carbamazepine- Oral Suspension	-			-
Cefipime -for Injection	-
Cetuximab	-
Clozapine - Oral Tablets	-		-
Colistimethate	-		-	-
Degarelix - for Injection	-			-
Dronedarone - Tablets	-	-	-
Galsulfase	-			-
Glucarpidase	-	-	-
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)	-			-
Humulin 70/30 (70% human insulin isophane suspension/30% insulin human injection, rDNA origin)	-	-	-	-
Humulin N NPH (human insulin isophane suspension [rNDA origin])	-	-	-	-
Humulin R (insulin human injection, USP [rDNA origin])	-	-	-	-
Infliximab	-
Inomax(nitric oxide) for Inhalation	-
Levemir (insulin detemir [rDNA origin] injection)	-			-
Losartan	-	-	-	-
Meropenem - for Injection	-			-
Metoprolol - 50mg/100mg Tablets	-			-
Metoprolol - 5mg/5ml Injection	-			-
Naproxen - Delayed-Release Tablets	-		-	-
Naproxen - Tablets	-		-	-
Naproxen - Tablets	-		-	-
Norfloxacin - Tablets	-	-	-
Novolin 70/30 (70% NPH, human insulin isophane suspension and 30% regular human insulin [rDNA origin]) Injection	-	-	-	-
Novolin N (NPH, human insulin isophane suspension [rDNA origin]) Injection	-	-	-	-
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)	-			-
Panitumumab	-			-
Pramipexole - Extended Release Tablets	-	-	-
Pramipexole - Tablets	-	-	-
Propafenone - Tablets	-			-
Silver Sulfadiazine - Cream	-		-	-
Sirolimus - Oral Suspension and Tablets	-	-	-
Solifenacin - Tablets	-	-	-
Sucralfate - Suspension		-	-
Sucralfate -Tablets		-
Ticagrelor -Tablets				-
Triptorelin Pamoate for Injectable Suspension	-	-	-
Ziprasidone - Capsules and Oral Suspension	-			-
Ziprasidone - Injection	-			-