Drug Safety Labeling Changes - December  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
Dexlansoprazole - Delayed-Release Capsules -
Dimethyl Fumarate - Delayed-Release Capsules, for Oral Use -
Lanreotide - (Somutaline Depot )Injection
Olanzapine Tablets
Olanzapine Orally Disintegrating Tablets
Olanzapine Zydis
Olanzapine Relprevv
-
Pantoprazole - Protonix IV -
Rabeprazole - Delayed-Release Tablets -
Ziprasidone - HCl Capsules -
Abatacept - -
Alcaftadine - Ophthalmic Solution
Amiodarone - HCl Tablets - -
Amlodipine Besylate and Benazepril - Capsules - - -
Aripiprazole - for Extended-Release Injectable Suspension, for Intramuscular Use - -
Aripiprazole - Tablets
Aripiprazole - Orally Disintegrating Tablets
Aripiprazole - Oral Solution
Aripiprazole - Injection FOR INTRAMUSCULAR USE ONLY
- -
Beclomethasone - Nasal Aerosol - -
Benazepril - Tablets - - -
Benazepril/ Hydrochlorothiazide - USP Combination Tablets - - -
Bupivacaine - Liposome Injectable Suspension - - -
Buprenorphine - Sublingual Tablet - -
Buprenorphine and Naloxone - Sublingual Tablets for Sublingual Administration - -
Buprenorphine and Naloxone - Sublingual Tablets for Sublingual Administration - -
Bupropion - Extended-Release Tablets for Oral Use -
Calcipotriene and Betamethasone - Ointment - - -
Captopril - Tablets, USP - - -
Clobazam - Tablets, for Oral Use
Clobazam Oral Suspension
-
Dextrose in Plastic Container -
Dolutegravir - Tablets for Oral Use - - -
Elvitegravir, Cobicistat, Emtricitabine, Tenofovir - Fixed Dose Combination Tablets -
Enalapril - Tablets - - -
Enalapril Maleate-Hydrochlorothiazide - - -
Esomeprazole - Delayed-Release Capsules, for Oral Use -
Esomeprazole - for Injection -
Fluoxetine - Tablets for Oral Use - -
Fluoxetine ; Olanzapine -
Flutemetamol F 18 Injection - for Intravenous Use - - -
Golimumab - Injection, for Subcutaneous Use
Golimumab - Injection, for Intravenous Use
-
Idarubicin - for injection, USP
Idamycin PFS
- - -
Imipenum and Cilastatin - for Injection - - -
Interferon beta-1b for Injection, for Subcutaneous Use -
Irinotecan - Intravenous Injection - - -
Ivacaftor -Tablets - -
Ketorolac - Ophthalmic Solution - - -
Lamotrigine -Tablets
Lamotrigine -Chewable Dispersible Tablets
Lamotrigine- Orally Disintegrating Tablets
Lamictal XR -Extended-Release Tablets
- - -
Lanreotide - (Somatuline Depot )Injection - -
Lansoprazole - Delayed Release Capsules
Lansoprazole - Delayed-Release Orally Disintegrating Tablets
-
Lisinopril - Tablets, for Oral Use - - -
Lisinopril and Hydrochlorothiazide - - -
Meropenem - for Injection - -
Naproxen and Esomeprazole - Delayed Release Tablets - -
Obinutuzumab - Injection, for Intravenous Infusion - -
Omeprazole - Delayed-Release Capsules
Omeprazole - for Delayed-Release Oral Suspension
- -
Omeprazole/ Sodium Bicarbonate - Powder for Oral Suspension - -
Omeprazole/Clarithromycin/ Amoxicillin - -
Paclitaxel - Protein-Bound Particles for Injectable Suspension - -
Pantoprazole - Delayed-Release Tablets -
Paroxetine - Capsules, for Oral Use -
Plasma-Lyte 56 and Dextrose 5 percent in Plastic Container - - -
Plerixa - for Injection, Solution for Subcutaneous Use - - -
Potassium Chloride in 5 Percent Dextrose Injection, USP in Plastic Container -
Ramucirumab - Injection, for Intravenous Use - -
Rivaroxaban - Tablets - - -
Ruxolitinib -Tablets, for Oral Use -
Sodium Chloride - Injection, USP in VIAFLEX Plastic Container -
Sunitinib - Capsules - -
Telavancin - for Injection, for Intravenous Use -
Telmisartan - Tablets - -
Telmisartan and Hydrochlorothiazide - Tablets - - -
Telmisartan/ Amlodipine - Tablets - -
Topiramate - Tablets
Topiramate - Sprinkle Capsules
- - -
Trandolapril - Tablets - - -
Trandolapril/ Verapamil Hydrochloride ER - 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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