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Drug Safety Labeling Changes - JUNE 2013

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
Methylphenidate - Oral Solution and Chewable tablets
Raltegravir - Tablet and Chewable Tablet
Sorafenib - Tablet
Terbinafine - Tablets
Aztreonam - injection in GALAXY Plastic Container and Aztreonam for Injection
Dasatinib -Tablets
Dextroamphetamine - Spansule, Sustained Release Capsules
Docetaxel - Injection Concentrate
Enoxaparin - Injection
Flurandrenolide - Cream and Cordran Ointment
Goserelin - Implant
Idursulfase - Injection, for intravenous use
Lapatinib -Tablets
Linagliptin -Tablets
Linagliptin and metformin hydrochloride - Tablets
Lisdexamfetamine - Capsules
Methylphenidate - Extended Release Tablets
Methylphenidate - Extended-Release Capsules
Methylphenidate - Tablets
Methylphenidate - Transdermal System
Nilotinib - Capsules
Perampanel - Tablets
Phentermine - Orally Dissolving Tablets
Plerixafor Injection - Subcutaneous
Rilpivirine - Tablets
Rivastigmine - Patch
Romidepsin - Lyophilized Powder
Spironolactone - Tablets
Terbinafine - Oral Granules
Ursodiol - Tablets
Valproic acid - Capsules and Oral Solution
Valproic Acid - Delayed Release Capsules

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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