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&hellip
Pedi-Cap End-Tidal CO2 Detectors Recalled - May be difficult to manually ventilate a patient or detect changes in CO2 levels&hellip
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&hellip
Liberte Coronary Stent Now Called VeriFLEX - Name change due to mix-ups with the company's TAXUS Liberté drug-eluting stents&hellip
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&hellip
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.&hellip
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&hellip
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&hellip
Safety Concerns with Philips Medical Alert Pendants - Emergency help buttons worn around the neck may pose a choking hazard if the cord becomes entangled&hellip
Stories in the November 2009 edition include:
Vaccines for 2009 H1N1 Influenza - Some basics about the 2009 H1N1 vaccine&hellip
Pedi-Cap End-Tidal CO2 Detectors Recalled - May be difficult to manually ventilate a patient or detect changes in CO2 levels&hellip
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&hellip
Liberte Coronary Stent Now Called VeriFLEX - Name change due to mix-ups with the company's TAXUS Liberté drug-eluting stents&hellip
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&hellip
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.&hellip
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&hellip
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&hellip
Safety Concerns with Philips Medical Alert Pendants - Emergency help buttons worn around the neck may pose a choking hazard if the cord becomes entangled&hellip
Companies in this press-release
