Drug Safety Labeling Changes - January 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes January - 2014, 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
Acetaminophen - 80 mg, 120 mg, 325 mg, and 650 mg Suppositories	-		-	-
Amiodarone -Tablets	-	-	-
Apixaban - 2.5 and 5 mg Tablets	-	-		-
Azacitidine - for Injection	-			-
Finasteride - Tablet, 1 mg	-	-	-
125 Phenytoin - Oral Suspension Phenytoin - Injection	-	-
Ambrisentan - 5 mg and 10 mg Tablets	-	-	-	-
Boceprevir - 200 mg capsules		-		-
Carbamazepine - Chewable Tablets, Carbamazepine - Oral Suspension Carbamazepine - Extended-Release Tablets	-	-		-
Doripenem - for Injection	-			-
Dronedarone - 400 mg Tablets	-			-
Fosphenytoin	-			-
Lidocaine - (4% and 8%) and Dextrose 5% Injection
Linezolid - Oral Tablets, 400 mg and 600 mg Linezolid - IV Injection, 2 mg/mL Linezolid - for Oral Suspension, 100 mg/5mL	-	-	-
Losartan -25 mg, 50 mg, and 100 mg Tablets	-			-
Losartan/Hydrochlorothiazide - 50/12.5 mg, 100/12.5 mg, and 100/25 mg Tablets	-			-
Nevirapine - Extended-Release Tablets	-	-	-
Nevirapine - Tablets and Oral Suspension	-	-	-
Quinapril and Hydrochlorothiazide - 10/12.5 mg, 20/12.5 mg, and 20/25 mg Tablets	-	-
Revatio 20 mg Tablets Revatio 10 mg/12.5 mL for Injection Revatio 10 mg/mL Powder for Oral suspension	-			-
Rivaroxaban - Tablets, 10 mg	-		-	-
Spironolctone and Hydrochlorothiazide - 25/25 mg, and 50/50 mg Tablets	-	-
Topiramate - Tablets (25mg, 50mg, 100mg, and 200mg) Topiramate - Sprinkle Capsules (15mg, and 25mg)	-			-