FDA MedWatch - November 2009 FDA Patient Safety News

FDA MedWatch - November 2009 FDA Patient Safety News

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…
Ingresando aquí, se accede a todos los videos:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=92#1

- 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…