Drug Safety Labeling Changes - February 2016

Creator: Madhumathi Palaniappan
Keywords: FDA label changes February - 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
Emtricitabine/ Tenofovir Tablets	-			-
Irbesartan/ Hydrochlorothiazide - Tablets	-
Candesartan - Tablets	-			-
Candesartan /Hydrochlorothiazide	-	-		-
Certolizumab - Lyophilized Powder and Solution for Subcutaneous Use	-
Dimethyl fumarate	-			-
Efavirenz/ Emtricitabine/ Tenofovir -Tablets	-	-		-
Elvitegravir/ Cobicistat/ Emtricitabine/Tenofovir - Tablets	-		-	-
Emtricitabine/Rilpivirine/ Tenofovir - Tablets	-			-
Fingolimod - Capsules				-
Fluorescein - Injection
Fluticasone furoate/ Vilanterol - Inhalation Powder	-	-	-
Golimumab - Injection	-	-	-
Hydroxyzine - Capsules and Oral Suspension		-
Lanthanum Carbonate - Chewable Tablets and Oral Powder	-
Macitentan - Tablets	-	-	-
Saquinavir - Capsules and Tablets	-			-
Umeclidinium and Vilanterol - Inhalation Powder, for Oral Inhalation	-	-	-
Valproic acid - Capsules Valproic acid - Oral Solution Divalproex sodium - Delayed Release Tablets Depakote Sprinkle Capsules Depacon (valproate sodium) - Injection Depakote ER (divalproex sodium) - Extended Release Tablets	-			-
Venlafaxine - Extended-Release Capsules	-	-	-
Zoster Vaccine, Live	-	-	-