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# FDA MedWatch - December 2014 Safety Labeling Changes posting includes 72 products with changes to Prescribing Information
- URL: https://www.foodconsumer.org/december_2014_safety_labeling_changes_posting_0115150303/
- Published: 2015-01-15T14:01:00.000Z
- Updated: 2026-09-22T18:11:23.000Z
- Description: FDA's MedWatch posting for December 2014 lists 72 products with revisions to boxed warnings, contraindications, warnings, precautions, adverse reactions or patient package inserts, among them Abilify, Nexium, Micardis, Geodon, Jakafi and Kalydeco.
- Author: Food Consumer
- Tags: Drug, Health News, #vivvo-import

The **MedWatch December 2014 Safety Labeling Changes** posting includes 72 products with safety labeling changes to the following sections: BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT.

The "Summary Page" table provides a listing of product names and safety labeling sections revised:

[http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm429250.htm](http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm429250.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)

The following drugs had modifications to the CONTRAINDICATIONS, or WARNINGS and PRECAUTIONS sections:

Abilify (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY   
Abilify (aripiprazole) Oral Solution  
Abilify (aripiprazole) Tablets  
Abilify DISCMELT (aripiprazole) Orally Disintegrating Tablets  
Abilify MAINTENA (aripiprazole) for extended-release injectable suspension, for intramuscular use  
Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension)  
Aciphex (rabeprazole sodium) Delayed-Release Tablets   
Brisdelle (paroxetine) capsules, for oral use   
Cyramza (ramucirumab) injection, for intravenous use  
Dexilant (dexlansoprazole) delayed-release capsules  
Dextrose in Plastic Container  
Extavia (interferon beta-1b) for injection, for subcutaneous use  
Gazyva (obinutuzumab) Injection, for Intravenous Infusion  
Geodon (ziprasidone HCl) capsules   
Idamycin (idarubicin hydrochloride for injection, USP)   
Idamycin PFS  
Jakafi (ruxolitinib) tablets, for oral use   
Kalydeco (ivacaftor) Tablets  
Lastacaft (alcaftadine ophthalmic solution)   
Micardis (telmisartan) Tablets   
Nexium (esomeprazole magnesium) delayed-release capsules, for oral use  
Nexium I.V. (esomeprazole sodium) for injection  
Omeclamox-Pak (omeprazole/clarithromycin/amoxicillin)  
Onfi (clobazam) oral suspension  
Onfi (clobazam) tablets, for oral use  
Orencia (abatacept)   
Potassium chloride in 5 Percent Dextrose Injection, USP in Plastic Container   
Prevacid (lansoprazole) delayed release capsules  
Prevacid SoluTab (lansoprazole) Delayed-Release Orally Disintegrating Tablets  
Prilosec (omeprazole magnesium) for delayed-release oral suspension  
Prilosec (omeprazole) delayed-release capsules  
Protonix (pantoprazole sodium) delayed-release tablets  
Protonix IV (pantoprazole sodium)  
Qnasl (beclomethasone dipropionate) Nasal Aerosol   
Sarafem (fluoxetine hydrochloride tablets) for oral use   
Simponi (golimumab) injection, for Subcutaneous Use  
Simponi Aria (golimumab) Injection, for Intravenous Use   
Sodium Chloride Injection, USP in VIAFLEX Plastic Container  
Somatuline Depot (lanreotide) Injection   
Somutaline depot (lanreotide) Injection   
Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) fixed dose combination tablets  
Suboxone (buprenorphine and naloxone) sublingual tablets for sublingual administration  
Subutex (buprenorphine) sublingual tablet  
Sutent (sunitinib malate) capsules  
Symbyax (fluoxetine hydrochloride; olanzapine)  
Tecfidera (dimethyl fumarate) delayed-release capsules, for oral use  
Twynsta (telmisartan/amlodipine) Tablets   
Vibativ (telavancin) for injection, for intravenous use   
Vimovo (naproxen and esomeprazole magnesium) delayed release tablets  
Wellbutrin XL (bupropion hydrochloride extended-release) tablets for oral use   
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension  
Zubsolv (buprenorphine and naloxone sublingual tablets) for sublingual administration   
Zyprexa (olanzapine) Tablets   
Zyprexa Orally Disintegrating Tablets  
Zyprexa Relprevv   
Zyprexa Zydis