Drug Safety Labeling Changes - January  2015

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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
Imatinib - Tablets - -
Nitroglycerin - Nitrolingual( Pumpspray) Spray
Abiraterone - Tablets - - -
Benazepril -Tablets - - -
Busulfan - Injection - - - -
Cilostazol - Tablets - - -
Clarithromycin - Tabs, Granules, XL Filmtabs - - -
Dalteparin - Injection - -
Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate -
Everolimus - Tablets and Afinitor Disperz Tablets - -
Everolimus -Tablets - -
Ibrutinib - Capsules - -
Infliximab - - -
Isosorbide Dinitrate -Tablets - -
Lisdexamfetamine - Tablets - - -
Medroxyprogesterone - Injection -
Milnacipran - Tablets - -
Minoxidil - Tablets - -
Modafinil - Tablets - - -
Nilotinib - Capsules - -
Procardia Capsules and Procardia XL (Nifedipine) Tablets - - -
Rocuronium - Injection - -
Valproic acid - Capsules and Oral Solution
Divalproex Sodium Delayed Release
Depakote ER Extended Release Tablets
Depakote Sprinkle Capsules (Divalproex Sodium Coated Particles in Capsules)
Depacon (Valproate Sodium) Injection
- -
Zoledronic Acid - Injection - -
Zoledronic Acid - 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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