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Drug Safety Labeling Changes - January 2015

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
Imatinib - Tablets
Benazepril -Tablets
Cilostazol - Tablets
Clarithromycin - Tabs, Granules, XL Filmtabs
Dalteparin - Injection
Everolimus - Tablets and Afinitor Disperz Tablets
Everolimus -Tablets
Ibrutinib - Capsules
Infliximab
Lisdexamfetamine - Tablets
Medroxyprogesterone - Injection
Modafinil - Tablets
Nilotinib - Capsules
Rocuronium - Injection
Valproic acid - Capsules and Oral Solution
Divalproex Sodium Delayed Release
Depakote ER Extended Release Tablets
Depakote Sprinkle Capsules (Divalproex Sodium Coated Particles in Capsules)
Depacon (Valproate Sodium) Injection
Zoledronic Acid - Injection
Zoledronic Acid - Injection

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

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
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