FDA MedWatch - November 2009 FDA Patient Safety News now available

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Title: FDA MedWatch - November 2009 FDA Patient Safety News now available
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch E-list. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Stories in the November 2009 edition include: 

Vaccines for 2009 H1N1 Influenza

Some basics about the 2009 H1N1 vaccine…

Pedi-Cap End-Tidal CO2 Detectors Recalled

May be difficult to manually ventilate a patient or detect changes in CO2 levels…  

Life-Threatening Skin Reactions with Intelence

New labeling for this HIV drug warns that the drug must be discontinued immediately if severe skin or hypersensitivity reactions develop…  

Liberte Coronary Stent Now Called VeriFLEX

Name change due to mix-ups with the company’s TAXUS Liberté drug-eluting stents…  

Inaccurate Readings with Philips Avalon Fetal Monitors

Inaccuracies include halving or doubling of the fetal heart rate, and switching between the fetal and maternal heart rates…  

Pure Red Cell Aplasia with Cellcept and Myfortic

Reducing the dose or stopping the drug may reverse the aplasia, but reducing immunosuppression in transplant patients could place the graft at risk.…  

Recall of ConMed Linvatec Surgical Handpieces and Cables

Switch problems may cause certain models to self-activate, continue to run after the trigger is released, or to run in the wrong direction…  

TNF Blockers and Cancer in Children

Updated boxed warning for Remicade, Enbrel, Humira, Cimzia, and Simponi...

Portex Uncuffed Pediatric Tracheal Tubes Recalled

Defect could increase airway resistance, and compromise the ability to ventilate a patient…  

Safety Concerns with Philips Medical Alert Pendants

Emergency help buttons worn around the neck may pose a choking hazard if the cord becomes entangled…

For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@xxxxxxx


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