FDA MedWatch Safety Alerts http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/MedWatch/rss.xml en-us Tue, 10 Nov 2009 14:50:00 -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 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 Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta. Mon, 02 Nov 2009 14:30:00 -0500 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188703.htm Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range. Fri, 30 Oct 2009 17:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188562.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188562.htm Nationwide recall due to stretching or fracture of the sheath during use. Fri, 30 Oct 2009 00:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188555.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188555.htm Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use. Tue, 27 Oct 2009 21:15:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm188151.htm Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers. Sat, 24 Oct 2009 16:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187814.htm Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist. Fri, 23 Oct 2009 16:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187791.htm Reports of sparking, charring, and fires from device power cords. Mon, 19 Oct 2009 14:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm187117.htm UPDATED 10/16/2009] Consumers warned of unapproved and illegal H1N1 drug products purchased over the internet. Fri, 16 Oct 2009 16:20:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183714.htm Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Fri, 16 Oct 2009 09:30:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator. Fri, 09 Oct 2009 16:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186081.htm Initial Notification of risk of radiation overexposures during CT brain perfusion scans. Fri, 09 Oct 2009 09:00:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186105.htm Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated. Mon, 05 Oct 2009 10:45:00 -0400 http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185179.htm http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm185179.htm