Drug Safety Labeling Changes - July 2016

Creator: Madhumathi Palaniappan
Keywords: FDA label changes July - 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
AbobotulinumtoxinA	-	-
Acetylcysteine Injection	-
Ado-trastuzumab Emtansine	-	-		-
Apixaban	-			-
Atazanavir/Cobicistat				-
Brimonidine
Canakinumab	-			-
Ciprofloxacin Hydrochloride Tablets, Solution, Oral Suspension Ciprofloxacin Extended Release Tablets	-
Clinolipid (Lipid Injectable Emulsion)	-	-
Clofazimine
Daptomycin for Injection	-	-	-
Dexamethasone	-	-	-
Dexlansoprazole Delayed-Release Capsules	-	-
Difluprednate	-	-	-
Docetaxel Injection	-	-	-
Empagliflozin	-			-
Empagliflozin and Linagliptin	-
Empagliflozin and Metformin Hydrochloride				-
Evolocumab	-	-	-	-
Exemestane	-			-
Fluorouracil	-	-	-	-
Fluticasone Propionate	-	-		-
Fluticasone Propionate Inhalation Powder	-	-
Formoterol Fumarate, Mometasone Furoate	-	-		-
Fulvestrant	-
Gemifloxacin Mesylate	-
Hicon (for the preparation of sodium iodide I 131 solution or sodium iodide I 131 capsules)
Humulin R U-500 (Insulin Human Injection	-			-
Isoniazid Tablets		-	-
Lamivudine Tablets and Oral Solution	-			-
Levofloxacin	-
Memantine and Donepezil Hydrochlorides Extended-Release	-			-
Meropenem for Injection	-	-	-
Mometasone Furoate	-	-		-
Moxifloxacin Hydrochloride	-
Moxifloxacin Injection	-
Nicotine Transdermal System	-	-	-	-
Nitazoxanide	-	-
Norfloxacin	-
Omalizumab Lyophilized Powder	-	-
Palifermin Injection	-
Peginterferon beta-1a	-	-		-
Pramipexole	-	-		-
Pramipexole Extended-Release	-	-
Prasugrel	-	-
Pravastatin Sodium	-	-
Prismasol and Phoxillum Renal Replacement Solution
Thallous Chloride T1201 Injection	-
Ticagrelor	-	-	-
Trabectedin	-
Trandolapril/ Verapamil Hydrochloride Extended Release Tablets	-	-		-
Vandetanib	-			-