Drug Safety Labeling Changes - January  2016

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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
Alosetron Hydrochloride Tablets - - - -
Aripiprazole - Tablets, Orally Disintegrating Tablets, Oral Solution, and Injection for INTRAMUSCULAR USE ONLY
Aripiprazole - for Extended-release Injectable Suspension, for Intramuscular Use
- - -
Carbachol - Intraocular solution, USP - -
Carfilzomib - for Injection - -
Clindamycin - Solution, Lotion, and Gel, 1 Percent - - -
Enalapril - 1 mg/mL Powder (reconstituted) for Oral Solution - -
Eribulin mesylate - Injection - -
Golimumab - Injection - -
Golimumab - Injection, for Intravenous Infusion - -
Hyaluronidase - Human Injection - - -
Ibuprofen - lysine Solution - - -
Iloperidone - Tablets - -
Lomustine - Capsules - - - -
Ombitasvir, Paritaprevir and Ritonavir - Tablets - - -
Ombitasvir, Paritaprevir, and Ritonavir -Tablets; Dasabuvir -Tablets - - -
OnabotulinumtoxinA - -
Oritavancin Diphosphate - Lyophilized Powder for Injection -
Pentoxifylline - Tablets - - -
Pramipexole - Tablets
Pramipexole- Extended-Release Tablets
- - -
Propylthiouracil - Tablets - -
Ranolazine - Extended-Release Tablets - - -
Telmisartan/ Amlodipine - Tablets - -
Topotecan - Injection - - - -
Trandolapril - Tablets - -
Trandolapril/ Verapamil - Tablets - -
Treprostinil - Extended Release 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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