FDA MedWatch - April 2010 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 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 clinicians and educators in healthcare facilities and academic institutions.

Stories in the April 2010 edition include:

Caution on Zyprexa for Adolescents 
Adolescents may be at greater risk for weight gain and hyperlipidemia than adults when treated with Zyprexa…

Certain Powerheart/CardioVive/CardioLife AED Recalled 
Recalled devices may fail to deliver therapy during a resuscitation attempt…

Recall of Q-Syte Luer Access Devices 
Affected devices may cause an air embolism or blood or therapy fluids to leak…

Cardiovascular Risk with Meridia 
Meridia (sibutramine), used to treat obesity, is now contraindicated in patients with a history of cardiovascular disease…

SafeSheath CSG Hemostatic Introducer Recalled 
The soft radiopaque tip may fracture while the lead is being implanted and leave fragments in a patient's vasculature…

Measuring Rapamune Blood Concentrations 
Different methods for assaying Rapamune (sirolimus) blood concentrations are not interchangeable and can give different results; may lead to improper dose adjustments…

Plastic Rotors for Hettich Centrifuges Recalled 
Rotors on affected models may crack apart and destroy centrifuge housing, creating a safety hazard…

Serious Liver Disorder with Videx 
Cases of a rare but serious complication, non-cirrhotic portal hypertension, have been reported in patients taking Videx (didanosine) or Videx EC, to treat HIV infection…

GlucoPro Insulin Syringes Recall 
Needles with expiration dates before November 2011 may detach from the syringe…

Potentially Fatal Salmonella Infections from Pet Turtles 
Turtles may look like cute pets but they are responsible for an estimated 70,000 cases of Salmonella infections each year…

From FDA