From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 06:47:36 -0500 (CDT)
Subject: FDA Patient Safety News - July edition
The July 2008 edition of FDA Patient Safety News is now available to watch at http://www.fda.gov/psn. Feel free to check out any of the stories in this edition as well as stories in previous programs.
The headlines for this month are:
New Medical Products
- New Skin Graft Adhesive Approved
- New Non-Refrigerated Coagulation Product
Recalls and Safety Alerts
- Update on Potentially Contaminated Heparin
- FDA Takes Action on Injectable Colchicine
- FDA Studying Potential Safety Issues with Several Drugs
Preventing Medical Errors
- Preventing Fatal Overdoses with Cerebyx
FDA Consumer Corner
- Albuterol Inhalers: Making the Switch
Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 06:58:43 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: July 2, 2008 |
The following new items were added to the CDRH web pages on July 1, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | FDA Public Health Notification: Life-threatening Complications Associated with Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion |  |
Update: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 08:15:49 -0500 (CDT)
Subject: FDA Warning Letters Update
You are subscribed to FDA Warning Letters for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 09:04:55 -0500 (CDT)
Subject: FDA Food Protection Plan Shows Significant Progress
FDA Food Protection Plan Shows Significant Progress
Wed, 02 Jul 2008 08:52:00 -0500
The U.S. Food and Drug Administration's Food Protection Plan Progress Report, released today in conjunction with the Interagency Working Group on Import Safety Action Plan Update, shows significant areas of activity to further improve the safety of America’s food supply since unveiling its Food Protection Plan in November 2007.
Update: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 10:30:17 -0500 (CDT)
Subject: Life-threatening Complications Associated with (rhBMP) in Cervical Spine Fusion - Medical Device Safety
A new public health notification describes serious adverse events associated with the use of recombinant human Bone Morphogenetic Protein (rhBMP) in cervical spine fusion. These products are not approved by FDA for this use.
Update: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 10:54:58 -0500 (CDT)
Subject: Public Health Notifications Update
You are subscribed to Public Health Notifications for U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health.
The FDA has posted a new Public Health Notification regarding use of Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion. This Notification alerts healthcare practitioners about serious airway complications occuring with the use of rhBMP in cervical spine fusion and recommends that healthcare practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies for rhBMP use in the cervical spine.
This Notification is available by clicking here.
Update: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 14:03:13 -0500 (CDT)
Subject: Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1)
Jack Distribution, LLC. Issues a Voluntary Nationwide Recall of Select Lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules (July 1)
Wed, 02 Jul 2008 13:11:00 -0500
Jack Distribution, LLC, and its wholesale distributors G and N Works, Inc., and Devine Distribution, Inc., announced today that they are conducting a voluntary nationwide recall of the following lot numbers of the company's supplement products sold under the brand names Rize 2 The Occasion and Rose 4 Her. (Rize 2 lot numbers CG-84 expires 11/10, GD-98 expires 08/10, CC-06 expires 06/10, 709 expires 09/10, CG-79 expires 11/10) (Rose 4 Her lot number CG-78 expires 11/10).
Update: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 15:33:34 -0500 (CDT)
Subject: FDA MedWatch -Rize 2 The Occasion Capsules And Rose 4 Her Capsules- Products Recalled Because They Contain An Undeclared Ingredient
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Jack Distribution, LLC issued a voluntary nationwide recall of selected lots of Rize 2 The Occasion Capsules and Rose 4 Her Capsules, marketed as dietary supplements. The products were recalled because certain lots contained thiomethisosildenafil, an undeclared ingredient that is an analog of sildenafil, a FDA-approved drug used for Erectile Dysfunction. This undeclared chemical poses a potential threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have one of the above products should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking the products. See the manufacturer's press release for the specific lot numbers of the recalled products.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this recall at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Rize
Update: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jul 2008 08:00:31 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index | | |
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| Date: July 3, 2008 |
The following new items were added to the CDRH web pages on July 2, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
| FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Performance Assessment - Guidance for Industry and FDA Staff | |  |
Update: 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jul 2008 12:28:19 -0500 (CDT)
Subject: Interstate Milk Shippers Update July 2008
* * * Interstate Milk Shippers List * * *
The quarterly Milk Shippers update is now available at http://www.cfsan.fda.gov/~ear/ims-toc.html.
July 2008 Update
Update: 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jul 2008 12:42:01 -0500 (CDT)
Subject: Recent Device Approvals: XIENCE V Stent (Abbott Vascular)
You are subscribed to Recent Device Approvals updates for U.S. Food & Drug Administration (FDA). Information about the Abbott XIENCE™ V Everolimus Eluting Coronary Stent on the Over-the-Wire (OTW) or Rapid Exchange (RX) Stent Delivery Systems has recently been posted to the FDA website, and is now available.
Update: 12
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jul 2008 13:03:42 -0500 (CDT)
Subject: FDA 101: Advisory Committees
FDA 101: Advisory Committees
Thu, 03 Jul 2008 12:25:00 -0500
FDA's Advisory Committees are critical to the agency's product review process. Find out the basics of putting special government employees with different perspectives on such scientific committees.
Update: 13
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Thu, 3 Jul 2008 13:03:58 -0500 (CDT)
Subject: Prepare for Hurricanes and Floods: Advice From FDA
Prepare for Hurricanes and Floods: Advice From FDA
Thu, 03 Jul 2008 12:25:00 -0500
This updated article gives tips on how to keep food, medical products, and pets safe during an emergency.
Update: 14
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 2 Jul 2008 12:29:39 -0500 (CDT)
Subject: FDA MedWatch- Recombinant Human Bone Morphogenetic Protein: Reports Of Life-threatening Complications In Cervical Spine Fusion
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FDA informed healthcare professionals of reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein (rhBMP) when used in the cervical spine. The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use. There have been at least 38 reports of complications during the last 4 years with the use of rhBMP in cervical spine fusion. These complications were associated with swelling of neck and throat tissue, which resulted in compression of the airway and/or neurological structures in the neck. Some reports describe difficulty swallowing, breathing or speaking. FDA recommends that practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies.
FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of rhBMP, you should follow the reporting procedure established by your facility. Reporting adverse events is everyone’s responsibility, even if the event involves off-label use of medical devices.
Read the entire 2008 MedWatch Safety Summary, including the FDA's Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Protein
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