Drug Safety Labeling Changes - June  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
Adalimumab -
Bendamustine Hydrochloride -
Bupropion - - -
Ceftazidime and Avibactam - -
Cobicistat -
Dapagliflozin
Dapagliflozin and Metformin HCl - Extended-Release
Darunavir -Tablet and Oral Suspension -
Dolutegravir - - -
Doxazosin - - -
Doxercalciferol -
Everolimus -
Filgrastim - - - -
Fosphenytoin - - -
Ibrutinib - - -
Ibuprofen - - -
Leuprolide - for depot suspension - - - -
Levocetirizine - Oral Tabs
Levocetirizine -Oral Solution
- - -
Levonorgestrel and Ethinyl Estradiol - - -
Macitentan - - -
Medroxyprogesterone acetate - - -
Nitisinone -
Nitroglycerin - -
Ombitasvir, Paritaprevir and Ritonavir - Tablets - -
Ombitasvir, Paritaprevir and Ritonavir tablets; dasabuvir tablets - - -
Oseltamivir - Capsules and Oral Suspension -
Panobinostat - -
Parathyroid hormone - -
Phenytoin - Injection and Oral Suspension - -
Piperacillin and Tazobactam for injection -
Pomalidomide - -
Ponatinib -
Quetiapine - - -
Rasburicase -
Regorafenib - -
Sapropterin - -
Tacrolimus - Extended Release - - -
Taliglucerase alfa - - -
Teriflunomide
Treprostinil -
Vigabatrin -Tablet
Vigabatrin - Oral Solution
-
Ziv-aflibercept Injection - - -

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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