Drug Safety Labeling Changes - DECEMBER  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
Adderall XR (mixed amphetamine salts) Capsules - - -
Alprostadil - for Injection - - -
Belimumab - -
Bevacizumab -
Carboprost - Sterile Solution Injection - -
Clopidogrel - Tablets -
Dabigatran - Capsules - - -
Dabrafenib - Capsules - - -
Desvenlafaxine -Extended-Release Tablets - - -
Dexmethylphenidate Tablets and Focalin XR Dexmethylphenidate Hydrochloride Extended-Release Tablets -
Dextroamphetamine - Spansule Sustained Release Capsules - - -
Docetaxel - Injection Concentrate -
Dofetilide - Capsules - - -
Florbetapir F 18 Injection - - -
Ipilimumab - -
Lamotrigine - Tablets, Chewable Dispersible Tablets
Lamotrigine - Orally Disintegrating Tablets
Lamotrigine - Extended-Release Tablets
- - -
Lisdexamfetamine - Capsules - - -
Mesalamine - Controlled-Release Capsules - - -
Mesalamine - Delayed-Release Tablets - - -
Mesalamine - Rectal Suppository - -
Methamphetamine -Tablets - - -
Methylphenidate - Extended-Release Capsules -
MethylPhenidate - Extended-Release Oral Suspension -
Methylphenidate - Extended-Release Tablets -
Methylphenidate - Oral Solution and Chewable Tablets -
Methylphenidate - Tablets
Methylphenidate - Sustained-Release Tablets
Methylphenidate - Extended-Release Capsules
-
Methylphenidate - Transdermal System -
Montelukast - Tablets, Chewable Tablets, and Oral Granules - - -
Natalizumab - Injection - -
Ondansetron - Tablets, Oral Solution, Injection
Ondansetron - Orally Disintegrating Tablets
- - -
Pantoprazole - for Injection - - -
Pantoprazole -for Delayed-Release Suspension, Delayed-Release Oral Tablets - - -
PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution - - -
Pegvisomant - Injection - - -
Ponatinib - Tablets - -
Ranolazine - Extended-Release Tablets -
Strontium-89 Chloride Injection - - -
Ticagrelor -Tablets - - -
Vilazodone Hydrochloride - Tablets - - -

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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