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FDA MedWatch Safety Alerts
http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml
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Thu, 09 Sep 2010 16:50:00 -0400
jay.wattenberg@fda.hhs.gov (Jay Wattenberg)
FDA MedWatch
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FDA MedWatch Safety Alerts
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis
New recommendations in labeling for screening for renal disease prior to use and monitoring for the development of NSF.
Thu, 09 Sep 2010 16:50:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225375.htm
AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation
Fragments of the catheter may become lodged in coronary arteries, resulting in serious injury or death.
Wed, 08 Sep 2010 13:50:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225186.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm225186.htm
Tygacil (tigecycline): Label Change - Increased Mortality Risk
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
Wed, 01 Sep 2010 10:00:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224626.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224626.htm
Huber Needles: Recall - Risk of Coring
Risk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs.
Thu, 26 Aug 2010 15:40:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224163.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224163.htm
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens
Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
Thu, 26 Aug 2010 14:30:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224135.htm
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224135.htm
TimeOut Capsules: Undeclared Drug Ingredient
Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil, a chemical similar to sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Wed, 25 Aug 2010 15:25:00 -0400
http://www.fda.gov/Safety/MedWatch/SafetyInf
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