The September 2010 FDA Patient Safety News is now available...

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Title: The September 2010 FDA Patient Safety News is now available...
FDA Patient Safety News - www.fda.gov/psn

You can find more information about FDA Patient Safety News, and watch or download the video program on our web site (http://www.fda.gov/psn).  Stories in the September 2010 edition include:

 

First Test to Detect Both HIV Antigen and Antibodies

The ARCHITECT HIV Ag/Ab Combo assay can help diagnose HIV infection before antibodies appear in the blood…

 

FDA Requirements for Colleague Infusion Pump Recall

How Baxter Healthcare is carrying out the recall of its Colleague volumetric infusion pumps…

Air/Gas Embolisms with Pressurized Spray Devices
Adverse events may be associated with not using the devices according to their labeling and instructions…

Expanded Recall of Hospira Liposyn and Propofol
Affected injectable products may contain particulate matter...

 

Recall of Certain LIFEPAK Defibrillators

Possible failures in AC or DC power that could delay or prevent these devices from delivering therapy…

 

Mylotarg Withdrawn from U.S. Market

Recent clinical trial failed to show clinical benefit for this cancer drug, and also raised safety concerns…

 

Suicide Risk with Tramadol

Revised warnings emphasize that certain patients have a higher risk of suicide if they are treated with tramadol…

 

Velcade and Hepatic Impairment

Patients with moderate to severe hepatic impairment who are beginning therapy with the drug should be started at reduced doses and closely monitored for toxicity…

 

Shortage of EPINEPHrine Syringes Can Cause Errors

ASHP and ISMP recommendations to help avoid errors during the shortage…

 

Avoiding Patient Injuries with Dermatome Instruments

Reports stated that the injuries resulted from improper maintenance…

 

Phase-Out of Epinephrine CFC Metered-Dose Inhalers

Epinephrine inhalers that use CFCs as a propellant, such as Primatene Mist, will not be sold in the U.S. after 2011…

 

For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@xxxxxxx

 

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