ZYNX HEALTH - Zynx Update - FDA Drug Safety Alerts

Zynx Update

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June 2012

FDA Drug Safety Alerts

Safety alerts issued by the FDA since March 18, 2012, relevant to medications referenced in Zynx evidence

3/23/2012
FDA Safety Alert - Eagle Pharmaceuticals, Inc. Argatroban Injection 50mg/50mL - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm297100.htm

3/28/2012
FDA Safety Alert - Citalopram Hydrobromide (CELEXA) - Update
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm297624.htm

4/3/2012
FDA Safety Alert - Bevacizumab (ALTUZAN) - Counterfeit Product
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298583.htm

4/5/2012
FDA Safety Alert - Thoratec Corporation HeartMate II Left Ventricular Assist System (LVAS) - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm298710.htm

4/10/2012
FDA Safety Alert - Birth Control Pills Containing Drospirenone - Update
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm299605.htm

4/18/2012
FDA Safety Alert - Sonic Generic Ultrasound Transmission Gel
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm

4/18/2012
FDA Safety Alert - Morphine Sulfate Injection 4 mg/mL Carpuject by Hospira, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300852.htm

4/20/2012
FDA Safety Alert - Aliskiren-containing Medications
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301120.htm

4/24/2012
FDA Safety Alert - Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm301483.htm

5/14/2012
FDA Safety Alert - HYDROmorphone Hydrochloride Injection 1 mg/mL Carpuject by Hospira, Inc. - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304044.htm

5/18/2012
FDA Safety Alert - Azithromycin (ZITHROMAX)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm304503.htm

5/23/2012
FDA Safety Alert - Hospira Carpuject Pre-filled Cartridges
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305236.htm

5/25/2012
FDA Safety Alert - Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305762.htm

5/25/2012
FDA Safety Alert - Dialysate Concentrates Used in Hemodialysis
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305630.htm

5/25/2012
FDA Safety Alert - Franck’s Compounding Pharmacy Sterile Preparations - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm305592.htm

5/30/2012
FDA Safety Alert - Teva’s ADDERALL 30 mg tablets - Counterfeit Product
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306041.htm

6/1/2012
FDA Safety Alert - REUMOFAN PLUS - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306360.htm

6/1/2012
FDA Safety Alert - MOOG Medical Devices Group, Curlin Infusion Administration Sets - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm306327.htm

6/6/2012
FDA Safety Alert - INTROVALE (levonorgestrel and ethinyl estradiol) Tablets - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm307103.htm

6/15/2012
FDA Safety Alert - Sigma Spectrum Infusion Pump Model 35700 - Recall
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm233747.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.