FDA MedWatch - May 2009 FDA Patient Safety News is now available

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Title: FDA MedWatch - May 2009 FDA Patient Safety News is 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 May 2009 edition include:

FDA Approves First Human Drug from Genetically Engineered Animals

ATryn, an anticoagulant is used to prevent blood clots in patients with a rare disease known as hereditary antithrombin deficiency…

Safety Problems with Baxter Colleague Volumetric Infusion Pumps

Certain failure codes may cause the pump to alarm and stop the infusion, which may lead to serious injury or death…  

Warning on Metoclopramide

Boxed warning highlights the risk of tardive dyskinesia if the metoclopramide (sold as Reglan and generics) is used for long periods of time or at high doses…

Burns from Medicated Patches during MRI Exams

Because the metallic component in a number of OTC and prescription transdermal patches can conduct heat, patients should remove the patch before the MRI...

Recall of Pediatric Tracheostomy Tubes

Certain lots of the Shiley 3.0 PED cuffless pediatric tracheostomy tubes should be returned to the company…

Alert on Metabolic Acidosis from Zonisamide

Measure serum bicarbonate before starting zonisamide treatment and periodically thereafter, even in the absence of metabolic acidosis symptoms…

Welch Allyn Automated External Defibrillators (AED) Recalled

Some of these defibrillators may fail to deliver defibrillation shocks during treatment of sudden cardiac arrest...

Removing Insulin from Cartons

Once opened, insulin vials stored in cardboard cartons may lead to potentially serious insulin mix-ups…

Don’t Share Insulin Pens Between Patients

Sharing insulin pens and cartridges can transmit hepatitis viruses, HIV, or other blood-borne pathogens...


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420


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