Drug Safety Labeling Changes - August 2014

Creator: Madhumathi Palaniappan
Keywords: FDA label changes August - 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
Eribulin Mesylate Injection For Intravenous Administration	-	-	-
Hydrocodone - Extended-Release Capsules, for Oral Use, CII	-
Paricalcitol - Capsules	-
Valproic acid - Delayed Release Capsules, for Oral Use	-	-
Adenosine - Injection, for Intravenous Use	-
Almotriptan - Tablets for Oral Use	-
Apixaban - Tablets for Oral Use	-			-
Aprepitant - Capsules	-	-	-
Axitinib -Tablets for Oral Administration	-			-
Bevacizumab - Solution for Intravenous Infusion	-	-	-
Bupropion - Sustained-Release Tablets, for Oral Use	-
Dabigatran - capsules for Oral Use	-	-		-
Dapagliflozin -Tablets, 5 mg and 10 mg	-	-		-
Diclofenac - Capsules	-	-	-	-
Estradiol - Vaginal Ring				-
Etravirine - 200 mg, 100 mg, and 25 mg tablets	-	-		-
Fosaprepitant Dimeglumine for Injection	-	-	-
Ifosfamide - for Injection	-	-		-
Lacosamide -Tablet, Film Coated for Oral use, CV Lacosamide) Injection for Intravenous use, CV Lacosamide - Oral Solution, CV	-	-		-
Levetiracetam - Extended-Release Tablets, for Oral Use	-
Levetiracetam - Injection for Intravenous Use	-	-	-
Levetiracetam - Tablets, for Oral Use Levetiracetam - Oral Solution	-	-	-
Lomitapide - Capsules, for Oral Use	-	-		-
Nicotine - polacrilex Gum	-		-	-
Panitumumab - Injection for Intravenous Infusion	-
Peginterferon alfa-2b for Injection, for Subcutaneous Use	-	-		-
Pioglitazone and Metformin Hydrochloride - Tablets for Oral Use	-	-	-	-
Radiogardase (Prussian Blue Insoluble) capsules, for oral use	-
Ropinirole - Tablet, Extended Release for Oral Use	-
Somatropin [rDNA origin] injection), for Subcutaneous use	-			-
Taliglucerase alfa - for injection, for intravenous use	-
Zoster Vaccine Live	-	-	-