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Drug Safety Labeling Changes - December 2014

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
Pantoprazole - Protonix IV
Rabeprazole - Delayed-Release Tablets
Ziprasidone - HCl Capsules
Abatacept
Amiodarone - HCl Tablets
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
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
Captopril - Tablets, USP
Clobazam - Tablets, for Oral Use
Clobazam Oral Suspension
Dolutegravir - Tablets for Oral Use
Enalapril - Tablets
Esomeprazole - Delayed-Release Capsules, for Oral Use
Esomeprazole - for Injection
Fluoxetine - Tablets for Oral Use
Golimumab - Injection, for Subcutaneous Use
Golimumab - Injection, for Intravenous Use
Idarubicin - for injection, USP
Idamycin PFS
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
Obinutuzumab - Injection, for Intravenous Infusion
Omeprazole - Delayed-Release Capsules
Omeprazole - for Delayed-Release Oral Suspension
Paclitaxel - Protein-Bound Particles for Injectable Suspension
Pantoprazole - Delayed-Release Tablets
Paroxetine - Capsules, for Oral Use
Ramucirumab - Injection, for Intravenous Use
Rivaroxaban - Tablets
Ruxolitinib -Tablets, for Oral Use
Sunitinib - Capsules
Telavancin - for Injection, for Intravenous Use
Telmisartan - Tablets
Telmisartan and Hydrochlorothiazide - Tablets
Topiramate - Tablets
Topiramate - Sprinkle Capsules
Trandolapril - 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