FDA MedWatch Safety Alerts http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml en-us Fri, 07 Mar 2014 08:20:00 -0500 jay.wattenberg@fda.hhs.gov (Jay Wattenberg) http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm052224.gif http://www.fda.gov/Safety/MedWatch/default.htm 144 52 FDA MedWatch Safety Alerts The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient could cause serious adverse health consequences that could be fatal. Fri, 07 Mar 2014 08:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388352.htm Increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin. Thu, 06 Mar 2014 20:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388328.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388328.htm Administration of a product contaminated with mold could result in life-threatening fungal peritoneal infection or sepsis. Thu, 06 Mar 2014 20:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388323.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388323.htm Reports of four deaths and five incidents of loss of consciousness or other symptoms of hypoperfusion, occurring in patients who were converted to the Pocket Controller after being originally trained on an older model. Wed, 05 Mar 2014 10:10:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388059.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm388059.htm Recalled products may interfere with oxygen delivery, resulting in inaccurate oxygen regulation in neonates. This may cause death in neonates, particularly those who are critically ill. Fri, 28 Feb 2014 15:20:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387731.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387731.htm Use of this recalled product may result in serious adverse health consequences. Tue, 25 Feb 2014 13:09:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387123.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387123.htm If a tracheal tube kinks, it can deprive the patient of adequate ventilation causing serious patient injury including hypoxic injury and/or anoxia, and death. Mon, 24 Feb 2014 14:28:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387041.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm387041.htm Intravenous administration of particles may lead to impairment of microcirculation, phlebitis, infection, embolism and subsequent infarction. Thu, 20 Feb 2014 15:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386618.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386618.htm Potential ventilator failure and reduced alarm functionality may result in serious adverse health consequences or death. Thu, 20 Feb 2014 08:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386561.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386561.htm UPDATED 02/17/2014. FDA lab testing finds N-acetyl-leucine in samples of recalled Medisca product labeled as L-citrulline. Originally posted 02/14/2014 Mon, 17 Feb 2014 20:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385978.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385978.htm Use of an inhaled product with glass particles has potential to cause choking which could be life-threatening. Aerosolization of small glass particles in airways could result in recurrent infections. Sat, 15 Feb 2014 09:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386133.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm386133.htm UPDATED 02/15/2014. Additional products added to recall. Fri, 14 Feb 2014 09:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385999.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385999.htm FDA has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. Tue, 11 Feb 2014 10:25:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385471.htm FDA testing confirmed the presence of gram-positive rod bacteria in the product, which can cause infection in patients. Fri, 07 Feb 2014 11:40:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm385125.htm FDA assessing safety issues based on two separate studies that suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. Fri, 31 Jan 2014 16:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384225.htm DMAA may cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, tightening in the chest or heart attack. Fri, 31 Jan 2014 13:40:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384081.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm384081.htm Incorrectly mixed product can result in the liquid mixture solidifying too slowly and could result in significant impact to the patient, including neurological deficits, pulmonary emboli and possibly death. Wed, 22 Jan 2014 13:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382556.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382556.htm Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Wed, 22 Jan 2014 10:25:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382461.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382461.htm Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Wed, 22 Jan 2014 10:18:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382457.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382457.htm Risk of serious or life-threatening allergic reaction. Sun, 19 Jan 2014 20:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382272.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382272.htm