Drug Safety Labeling Changes - January 2016

Creator: Madhumathi Palaniappan
Keywords: FDA label changes January - 2016, 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
Alosetron Hydrochloride Tablets	-	-	-	-
Aripiprazole - Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection for INTRAMUSCULAR USE ONLY Aripiprazole - for Extended-release Injectable Suspension, for Intramuscular Use	-	-	-
Carbachol - Intraocular solution, USP	-		-
Carfilzomib - for Injection	-			-
Clindamycin - Solution, Lotion, and Gel, 1 Percent	-	-	-
Enalapril - 1 mg/mL Powder (reconstituted) for Oral Solution	-			-
Eribulin mesylate - Injection	-			-
Golimumab - Injection	-			-
Golimumab - Injection, for Intravenous Infusion	-			-
Hyaluronidase - Human Injection	-	-		-
Ibuprofen - lysine Solution	-	-	-
Iloperidone - Tablets		-	-
Lomustine - Capsules	-	-	-	-
Ombitasvir, Paritaprevir and Ritonavir - Tablets	-	-		-
Ombitasvir, Paritaprevir, and Ritonavir -Tablets; Dasabuvir -Tablets	-	-		-
OnabotulinumtoxinA	-			-
Oritavancin Diphosphate - Lyophilized Powder for Injection				-
Pentoxifylline - Tablets	-	-		-
Pramipexole - Tablets Pramipexole- Extended-Release Tablets	-	-	-
Propylthiouracil - Tablets	-			-
Ranolazine - Extended-Release Tablets	-	-	-
Telmisartan/ Amlodipine - Tablets	-	-
Topotecan - Injection	-	-	-	-
Trandolapril - Tablets	-			-
Trandolapril/ Verapamil - Tablets	-			-
Treprostinil - Extended Release Tablets	-	-	-