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Drug Safety Labeling Changes - June 2016

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
Adalimumab
Bendamustine Hydrochloride
Bupropion
Dapagliflozin
Darunavir -Tablet and Oral Suspension
Dolutegravir
Doxazosin
Doxercalciferol
Everolimus
Filgrastim
Fosphenytoin
Ibrutinib
Ibuprofen
Leuprolide - for depot suspension
Levocetirizine - Oral Tabs
Levocetirizine -Oral Solution
Nitisinone
Oseltamivir - Capsules and Oral Suspension
Panobinostat
Phenytoin - Injection and Oral Suspension
Pomalidomide
Ponatinib
Quetiapine
Rasburicase
Regorafenib
Tacrolimus - Extended Release
Taliglucerase alfa
Teriflunomide
Treprostinil
Vigabatrin -Tablet
Vigabatrin - Oral Solution

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