Drug Safety Labeling Changes - JUNE  2013

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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 - - -
Rotavirus Vaccine, Live, Oral, Pentavalent Oral Solution - -
Sorafenib - Tablet - - -
Terbinafine - Tablets -
Adderall XR (mixed amphetamine salts) capsules - -
Aflibercept Injection - - -
Aztreonam - injection in GALAXY Plastic Container and Aztreonam for Injection - - -
Colesevelam HCl Tablets and Oral Suspension -
Dasatinib -Tablets - - -
Depakote ER (Extended Release) Tablets - -
Dexmethylphenidate Hydrochloride - Tablets and Extended-Release Capsules - -
Dextroamphetamine - Spansule, Sustained Release Capsules - -
Divalproex Sodium Coated Particles in Capsules - -
Divalproex sodium Delayed Release - -
Docetaxel - Injection Concentrate - - -
Emtricitabine/rilpivirine/tenofovir - fixed dose combination (FDC) tablets - - -
Emtricitabine/Tenofovir - Tablets - -
Enoxaparin - Injection - - -
Flurandrenolide - Cream and Cordran Ointment - - -
Goserelin - Implant - - -
Idursulfase - Injection, for intravenous use -
Immune Globulin Products (Human) intravenous, subcutaneous, and intramuscular - - - -
Lapatinib -Tablets - -
Levonorgestrel/Ethinyl Estradiol - Tablets - - -
Linagliptin and metformin hydrochloride - Tablets -
Linagliptin -Tablets -
Lisdexamfetamine - Capsules - -
Methylphenidate - Extended Release Tablets - -
Methylphenidate - Extended-Release Capsules - -
Methylphenidate - Tablets - -
Methylphenidate - Transdermal System - -
Nilotinib - Capsules - - -
Paclitaxel protein-bound particles (albumin-bound)) for injectable suspension - - -
Perampanel - Tablets - -
Phentermine - Orally Dissolving Tablets - -
Plerixafor Injection - Subcutaneous
Rilpivirine - Tablets - - -
Ritalin LA (Extended-Release Capsules) - -
Ritalin SR (Extended-Release Tablets) - -
Rivastigmine - Patch -
Romidepsin - Lyophilized Powder - - -
Spironolactone - Tablets
Spironolactone/HCTZ Tablets
Terbinafine - Oral Granules -
Ursodiol - Tablets
Valproate sodium Injection - -
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

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