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

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Title: FDA MedWatch - September 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 September 2009 edition include:

New Warnings on Propoxyphene Overdoses

Danger of overdosing if drugs such as Darvon and Darvocet are taken at higher than recommended doses…  

Fire Hazard with Stabilet Infant Warmers

Recalled warmers should be taken out of service as soon as possible…  

Warning on Neuropsychiatric Effects from Smoking Cessation Drugs

Risk of serious neuropsychiatric effects with Chantix (varenicline) and Zyban (bupropion)…  

Nephropathy with Certain Organ Transplant Drugs

Risk of BK virus-associated nephropathy, primarily seen in kidney transplant patients…  

Recall of Medtronic Mini-Med Paradigm Quick-Set Infusion Sets

Patients who have the recalled infusion sets from affected lots should stop using them and return them to Medtronic for replacement…

Possible Cancer Risk with Lantus

Observational studies suggest an increased cancer risk associated with Lantus (insulin glargine)…

FDA Studying Cleaning Procedures for Arthroscopic Shavers

FDA is asking facilities that find tissue in these devices after they have been cleaned according to the manufacturer's instructions to report through FDA's MedWatch program…  

Update on Cefepime Safety Data

FDA's further analysis has not found an increased death rate in patients taking cefepime, sold as Maxipime and generics…  

Preventing Skin Burns from Surgical Microscopes

Infants, the elderly and those with poor circulation can be particularly vulnerable to skin burns…

Patient Deaths from Injection of Topical Epinephrine

ISMP recommendations to help prevent these potentially fatal mix-ups…


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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This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

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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

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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