Drug Safety Labeling Changes - February  2014

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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
Acitretin - Capsules - - - -
Arformoterol Tartrate Inhalation - Solution - - -
Naproxen/Esomeprazole - Delayed-Release Tablets - - -
Omeprazole/Sodium Bicarbonate - Capsules - - -
Sitagliptin and Metformin HCl - Extended-Release Tablets - - - -
Tolvaptan - Tablets - -
Anagrelide - Capsules - -
Atomoxetine - Capsules - - -
Azathioprine - Tablets and Injection - - -
Boceprevir - 200 mg Capsules -
Carbidopa -
Dexamethasone - Intravitreal Implant - - -
Eltrombopag - Tablets -
Esomeprazole - Delayed-Release Oral Suspension - - -
Esomeprazole - for Intravenous Injection - - -
Eszopiclone - Film Coated Oral Tablets - - -
Everolimus - Tablets for Oral Administration
Everolimus - Tablets for Oral Suspension
- -
Ezetimibe/Simvastatin - Tablets -
Famotidine - Tablet - - -
Golimumab - Injection For Intravenous Use - -
Ketoconazole - Tablet - -
Lomitapide Capsules - - -
Lovastatin -
Menotropins - for Injection -
Omeprazole - Delayed-Release Capsules - - -
Omeprazole - Delayed-Release Oral Suspension - - -
Omeprazole/Sodium Bicarbonate - Powder for Oral Suspension - - -
Palonosetron - Injection - -
Praziquantel Tablets - -
Rivaroxaban - Tablets - - -
Simvastatin Tablets -
Sitagliptin and Simvastatin - Tablets -
Tacrolimus - Extended-Release Capsules -
Urofollitropin - for Injection, Purified -
VemurafenibTablets -

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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