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

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Title: FDA MedWatch - August 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 August 2009 edition include:

 

Liver Failure with Propylthiouracil

Certain patients, and especially children, should only be treated with the anti-thyroid propylthiouracil if they cannot take methimazole…

 

Neuropsychiatric Events with Certain Asthma Drugs

Precautions added to the labeling of the leukotriene modifiers drugs Accolate, Zyflo, Zyflo CR, and Singulair on the possibility of neuropsychiatric events…

 

Recall of Certain Infant Apnea Monitors

SmartMonitor 2, Models 4002 and 4003 with specific serial numbers may fail to alarm if the infant experiences breathing problems or an abnormal heart rate… 

 

Alert on Stolen Levemir Insulin

Stolen Levemir may be dangerous to use, so patients should check their supply…

 

Serious Fungal Infections with Simponi

Simponi, like other immunosuppressant drugs used to treat chronic inflammatory diseases, should be discontinued if infections such as histoplasmosis occur…

 

Practicing Hospital Bed Safety

Avoid patient entrapment and electrical fires when using hospital beds in health care facilities and at home... 

 

Antiepileptic Drugs and Suicidality

Closely monitor all patients starting or taking antiepileptic drugs for changes in behavior… 

 

Increased Mortality with Rapamune in Liver Transplants

Safety and efficacy of Rapamune (sirolimus) have not been established in liver or lung transplant patients…

 

Certain Skin Sanitizers/Protectants Contaminated

Recall of certain skin care products made by Clarcon Biological Chemistry Laboratory due to high levels of bacteria…

 

Intranasal Zinc May Cause Loss of Smell

FDA is advising patients not to use Zicam Cold Remedy Nasal products that are administered directly into the nose…


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

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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