Drug Safety Labeling Changes - November  2014

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
Duloxetine - Delayed-Release Capsules - -
Fluticasone Propionate and Salmeterol Xinafoate - Inhalation Powder, Advair HFA Inhalation Aerosol - - -
Montelukast - Tablets, Chewable Tablets and Oral Granules - - -
Pazopanib - Tablets - -
Ambenonium Chloride - Tablets - -
Ampicillin /Sulbactam - Injection -
Bosutinib - Tablets - -
Brentuximab Vedotin - for Injection - -
Cinacalcet -Tablets -
Daptomycin - For Injection Intravenous - -
Depakote Sprinkle Capsules (divalproex sodium coated particles in capsules),
Depakote ER (divalproex sodium) Extended Release Tablets
- - -
Diltiazem - Tablets - -
Docetaxel - Injection Concentrate - -
Flovent HFA - Inhalation Aerosol  - - -
Fluticasone Propionate - Inhalation Powder - - -
Foscarnet - Injection - -
Gadodiamide - Injection,
Gadodiamide - Pharmacy Bulk Package Injection
- - -
Gemfibrozil - Tablets - -
Leflunomide - Tablets
Moxifloxacin Hydrochloride - 400 mg Tablets and Moxifloxacin Hydrochloride in Sodium Chloride Injection) IV - -
Nitrofurantoin - Oral Suspension - - -
OptiMARK Injection,
OptiMARK in Plastic Container,
OptiMARK Pharmacy Bulk Package Injection
- - -
Peginterferon alfa-2b - - -
Rifabutin - Capsules - -
Sofosbuvir -Tablet - -
Tapentadol - Oral Solution - - -
Tocilizumab - - -
Valproate Sodium Injection - - -
Valproic Acid - Capsules and Oral Solution - - -
Vemurafenib - Tablet -

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