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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
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
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
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