FDA MedWatch Safety Alerts http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml en-us Fri, 20 Nov 2009 18:00:00 -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 FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo. Fri, 20 Nov 2009 18:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use. Thu, 19 Nov 2009 20:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191471.htm Product found containing the bacteria B. cepacia. Thu, 19 Nov 2009 19:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191413.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191413.htm Recall of product, sold as a dietary supplement, containing undeclared sulfoaildenafil. Wed, 18 Nov 2009 08:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191052.htm Nationwide recall due to stretching or fracture of the sheath during use. Tue, 17 Nov 2009 14:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190967.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190967.htm Five products marketed as dietary supplements contain undeclared substances considered to be steroids. Tue, 17 Nov 2009 13:45:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190925.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190925.htm Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole. Tue, 17 Nov 2009 10:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190848.htm Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT. Mon, 16 Nov 2009 11:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190704.htm Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein. Fri, 13 Nov 2009 16:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices. Fri, 13 Nov 2009 13:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190496.htm Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions. Fri, 13 Nov 2009 12:55:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190480.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190480.htm Reports of loss of device height, which may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for surgery to modify the implanted device. Thu, 12 Nov 2009 15:55:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190330.htm 14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient. Tue, 10 Nov 2009 14:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189839.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189839.htm Product, used during cardiopulmonary bypass procedures, may spontaneously rupture during surgery. Mon, 09 Nov 2009 22:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow. Mon, 09 Nov 2009 14:50:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189589.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189589.htm Consumers warned that product sold as a dietary supplement contains sulfoaildenafil. Thu, 05 Nov 2009 14:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189300.htm Kits recalled because the pediatric tracheal tubes were manufactured with an internal diameter smaller than indicated on the label. Wed, 04 Nov 2009 09:40:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188981.htm Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product. Tue, 03 Nov 2009 21:15:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187481.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187481.htm Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury. Tue, 03 Nov 2009 21:00:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188957.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188957.htm Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly. Tue, 03 Nov 2009 10:09:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185702.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185702.htm