Drug Safety Labeling Changes - July  2016

Email bookmark
Font : A-A+

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
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 - -

2016 - Monthly Summary Report for Drug Label Changes

2015 - Monthly Summary Report for Drug Label Changes

2014 - Monthly Summary Report for Drug Label Changes

2013 - Monthly Summary Report for Drug Label Changes

2012 - Monthly Summary Report for Drug Label Changes

Buy Medication (Drug) at Concessional Price from India

Drugs A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

Drugs Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Stay Connected

  • Available on the Android Market
  • Available on the App Store