Saturday, August 2, 2008

U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

Update: 1

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 08:01:46 -0500 (CDT)
Subject: CDRH New Update

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CDRHNEW Logo Date: August 1, 2008

The following new items were added to the CDRH web pages on July 31, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Orthopaedic and Rehabilitation Devices Panel Advisory Meeting, July 15, 2008 - Agenda, Roster, Briefing, Questions, Brief Summary, Slides Text
* Summary Information for: SPOT-Light® HER2 CISH Kit
PDF

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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 13:25:26 -0500 (CDT)
Subject: CDER New 7/31/2008

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Center for Drug Evaluation and Research, U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website

CDERnew Logo

July 31, 2008

Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 14:03:14 -0500 (CDT)
Subject: Warnings on Raw Jalapeño and Serrano Peppers from Mexico

Warnings on Raw Jalapeño and Serrano Peppers from Mexico
Fri, 01 Aug 2008 14:00:00 -0500

Until further notice, FDA is advising consumers to avoid raw serrano peppers from Mexico, in addition to raw jalapeño peppers from Mexico, and any foods that contain them.

Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 15:10:28 -0500 (CDT)
Subject: The August 2008 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 August 2008 edition include:

Warning Added to Regranex (becaplermin) Label

Use caution when treating diabetic foot and leg ulcers with Regranex in patients who have known malignancies…

Cellcept and Myfortic Linked to Birth Defects and Fetal Loss

Before prescribing these drugs, healthcare professionals should ensure that women are not pregnant and are using two effective forms of birth control…

Possible Association between TNF Blockers and Cancer

Ongoing safety reviews of Remicade, Enbrel, Humira, and Cimzia…

Danger Giving Topical Thrombin Intravascularly

ISMP recommends ways to reduce the risk of errors that can lead to extensive intravascular clotting and death…

Potential Problems with Insulin Pens in Hospitals

Insulin pen design and usage issues can present safety concerns…

Nonoxynol 9 (N9) Contraceptives: No Protection against HIV and Other STDs

Labeling warns that using nonoxynol 9 may increase the risk of contracting HIV/AIDS from an infected partner…

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

You are receiving this message because you subscribed to the FDA Patient Safety News mailing list. If you would like to modify your subscription or no longer wish to receive these messages, please go to http://www.accessdata.fda.gov/psn/mailinglist.cfm

Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 15:54:52 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update August 2008

* * * Interstate Certified Shellfish Shippers List * * *

The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.

August 2008 Update

Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Fri, 1 Aug 2008 17:25:47 -0500 (CDT)
Subject: MedWatch - Levitronix CentriMag Extracorporeal Blood Pumping System: risk of pump stoppage with use of certain electrosurgery units

MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
Audience: Cardiothoracic healthcare professionals, perfusionists, hospital risk managers, biomedical engineers


Levitronix and FDA notified healthcare professionals of a Class 1 recall of the Levitronix CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles manufactured by Levitronix, GmbH, Zurich, Switzerland and distributed from January, 2001 through March, 2008. The Blood Pumping System is used to provide short-term extracorporeal circulatory support during cardiac and other types of surgeries. This device temporarily replaces the function of the heart and lungs in order to maintain the appropriate circulation of blood and oxygen levels in the body during the surgical procedure. A July 24, 2008 Levitronix device correction letter informed physicians not to use Valleylab Force FX-C or SSE2L electrosurgery devices with the CentriMag Blood Pumping System because use may result in stoppage of the pump and may cause serious injury or death. This recall action is an interim fix while the firm further investigates the source of the problem.

Read the complete MedWatch 2008 Safety summary, including links to the FDA recall notice and the Levitronix Dear Doctor letter, at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#CentriMag

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