ZYNX HEALTH - Zynx Update - FDA Drug Safety Alerts

Zynx Update

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March 2013

FDA Drug Safety Alerts

Safety alerts issued by the FDA since December 16, 2012, relevant to medications referenced in Zynx evidence

12/17/2012
FDA Safety Alert - CARBOplatin Injection by Hospira, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332358.htm

12/19/2012
FDA Safety Alert - Dabigatran Etexilate Mesylate (PRADAXA) - Drug Safety Communication
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332949.htm

12/19/2012
FDA Safety Alert - Telaprevir (INCIVEK) in Combination with Peginterferon Alfa and Ribavirin (INCIVEK Combination Treatment) - Drug Safety Communication
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332860.htm

12/19/2012
FDA Safety Alert - Zicam Extreme Congestion Relief Nasal Gel - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm332830.htm

12/21/2012
FDA Safety Alert - Life Pulse High-Frequency Ventilator Patient Circuits by Bunnell, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333262.htm

12/21/2012
FDA Safety Alert - Adult and Pediatric Manual Resuscitators by Ventlab Corporation - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333261.htm

12/21/2012
FDA Safety Alert - Drug Infusion Pumps by Medtronic, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333251.htm

12/21/2012
FDA Safety Alert - HYDROcodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm331224.htm

12/28/2012
FDA Safety Alert - T-Piece Circuits for the Giraffe and Panda Resuscitation Systems by GE Healthcare - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333646.htm

12/28/2012
FDA Safety Alert - PEEK Ardis Inserter by Zimmer Spine, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333592.htm

1/3/2013
FDA Safety Alert - Praxair Inc., Grab ‘n Go Vantage Portable Oxygen Cylinder Units - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333881.htm

1/7/2013
FDA Safety Alert - Fisher and Paykel Healthcare Reusable Breathing Circuit - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm334446.htm

1/17/2013
FDA Safety Alert - Metal-on-Metal Hip Implants - Updated Safety Recommendations
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336069.htm

1/18/2013
FDA Safety Alert - Ferrous Sulfate Tablets, 325 mg Labeled as Rugby NATURAL IRON SUPPLEMENT - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm336137.htm

1/28/2013
FDA Safety Alert - Lactated Ringers and 5% Dextrose Injection, USP, 1,000 mL, Flexible Containers - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337089.htm

1/30/2013
FDA Safety Alert - Vycor Viewsite Brain Access System - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337475.htm

2/4/2013
FDA Safety Alert - Z Pro High Protein Supplement - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337928.htm

2/8/2013
FDA Safety Alert - HAMILTON-T1 Ventilators with Software Versions 1.1.2 and Lower - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm338789.htm

2/13/2013
FDA Safety Alert - St. Jude Medical, AMPLATZER TorqVue FX Delivery System - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339593.htm

2/15/2013
FDA Safety Alert - GE Healthcare, LLC, Giraffe and Panda T-Piece Resuscitation Systems and Mask Resuscitation Systems - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm339884.htm

2/22/2013
FDA Safety Alert - DePuy Orthopaedics LPS Diaphyseal Sleeve - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340740.htm

2/25/2013
FDA Safety Alert - Lumenis VersaCut Tissue Morcellator - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340976.htm

2/25/2013
FDA Safety Alert - Peginesatide (OMONTYS) Injection by Affymax and Takeda - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm340895.htm

3/7/2013
FDA Safety Alert - Ad-Tech Macro Micro Subdural Electrodes - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm342834.htm

3/12/2013
FDA Safety Alert - Azithromycin (ZITHROMAX or ZMAX) - Risk of Potentially Fatal Heart Rhythms
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343350.htm

3/12/2013
FDA Safety Alert - NIGHT BULLET - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343283.htm

3/14/2013
FDA Safety Alert - Incretin Mimetic Drugs for Type 2 Diabetes
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343805.htm

3/15/2013
Safety Alert - Stryker Instruments Neptune 1 Silver and Neptune 2 Ultra Waste Management System (Neptune 1 Silver and Neptune 2 Ultra): Safety Communication - Update
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm322811.htm

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Zynx Update does not address the addition, deletion, or modification of clinical rules, nor does it address the addition of items or the deletion of non–evidence-based items from order sets or plans of care. Zynx Update is intended for use by quality improvement personnel who can review the information provided to help decide if modifications should be made to existing order sets, plans of care, and rules, based on changes to the evidence.