Update : 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 08:27:29 -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 : 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 09:23:00 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Approval Information: Tuberculin, Purified Protein Derivative (Aplisol)
Posted: 10/1/2008, Approval Date: 9/23/2008
Update : 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 11:35:28 -0500 (CDT)
Subject: The October 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Highlighted articles include:
Cutting a Battery Pack Cable Can Start a Fire
Cutting a battery pack cable can cause short circuits. In turn, can cause the batteries to discharge rapidly and produce intense heat and flammable gases. This article provides recommendations to avoid the risks of sparks, fires, toxic fumes and explosions. The summary of a recent MedSun report on battery packs in the clinical environment is also available...
Reporting Tip: Reporting Problems with Reprocessed Single Use Devices to FDA
This reporting tip clarifies how health professionals can best report an adverse event with a reprocessed single use device to the FDA...
Interventional Fluoroscopy: Reducing Radiation Risks
Interventional fluoroscopy is an increasingly important and valuable tool for treating disease, but it is not without risk. That is why it is important for the health care community, manufacturers and regulators to work together to optimize patient radiation dose...
Misprogramming PCA Concentration Leads to Dosing Errors
ISMP has received a small but concerning number of reports of overdoses with patient controlled analgesia (PCA) due to pump programming errors. Although every aspect in the PCA process has the potential for an error, ISMP is especially concerned about errors related to programming the concentration of the narcotic...
Proper Positioning of Pharmacy Label on Hospira PCA Vials will Avoid Interference with Scanning
A recent overdose was associated with the way pharmacy applied labels after preparing fentanyl PCA doses using the pump's compatible empty sterile glass vials. This article provides safe practice recommendations to prevent these errors...
FDA Clears Test to Help Doctors Manage Heart Transplant Patients
A non-invasive test that uses molecular expression techniques to assist doctors in managing heart transplant patients post-surgery for potential organ rejection has been cleared for marketing by the FDA...
FDA Approves Software Update that Identifies Potential Defibrillator Lead Fractures
The FDA has approved a software update from Medtronic that will help detect fractures of the company's Sprint Fidelis cardiac defibrillator lead. The new software package will alert both patients and physicians of a potential lead fracture...
FDA Approves DNA Test to Measure Hepatitis B Virus Levels
FDA has approved the first nucleic acid test for hepatitis B virus (HBV) that measures the amount of viral DNA (viral load) in a patient's blood. Assessing a patient's viral load provides health care professionals with a highly sensitive method for gauging the progress of antiviral therapy in patients with chronic HBV infections...
ROC Curves: Uncovering the Pearls and Avoiding the Pitfalls
ROC (receiver operating characteristic) curves are helpful for selecting optimal cutoffs for a test and have become a common tool in medicine to determine the clinical accuracy of lab tests...
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Update : 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 14:06:03 -0500 (CDT)
Subject: What's New at CBER Update
You are subscribed to What's New at CBER for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.
Influenza Virus Vaccine 2008/2009 Season Lot Release Status - Update
Posted: 10/1/2008
Update : 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:39:35 -0500 (CDT)
Subject: The October 2008 FDA Patient Safety News is now available...
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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 October 2008 edition include:
Warning on Tendon Injuries with Fluoroquinolone Antibiotics
Boxed warning and Medication Guide needed to draw attention to the risk of tendon rupture and tendinitis with fluoroquinolone drugs such as Cipro…
CT Scanning May Cause Malfunction of Electronic Medical Devices
X-rays emitted during CT exams could adversely affect insulin pumps, neurostimulators, pacemakers, defibrillators…
Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents
Contrast agents Definity and Optison are no longer contraindicated for patients with unstable cardiopulmonary status; however, these high risk patients should be closely monitored…
Avoiding Cardiotoxicity with Mitoxantrone
The importance of monitoring LVEF during and after treatment with mitoxantrone…
Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine
The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use…
Potentially Fatal Glucose Monitoring Errors with Icodextrin
Some point-of-care glucose meters use a type of test strip that can't distinguish between glucose and other sugars…
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 : 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:52:02 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update October 2008
* * * Interstate Certified Shellfish Shippers List * * *
The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.
October 2008 Update
Update : 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:03:32 -0500 (CDT)
Subject: Enforcement Report for October 1, 2008
Enforcement Report for October 1, 2008
Wed, 01 Oct 2008 13:34:00 -0500
Weekly report by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.
Update : 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 15:21:13 -0500 (CDT)
Subject: FDA Information Update for Health Professionals - October 1, 2008
U.S. Food and Drug Administration
Office of Special Health Issues
5600 Fishers Lane, HF-12
Rockville, Maryland 20857
Dear Colleague,
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety information, announcements, and upcoming meetings. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
FDA Analysis Shows Cholesterol Lowering Medications Do Not Increase the Risk of Lou Gehrig's Disease (September 29)
A U.S. Food and Drug Administration's analysis provides new evidence that the use of statins does not increase incidence of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as "Lou Gehrig's Disease." The analysis was reported on Monday, Sept. 29, 2008 in Pharmacoepidemiology and Drug Safety.
FDA Warns Companies to Stop Marketing Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain (September 23)
FDA announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drug products containing papain must stop manufacturing and marketing these products or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses.
Epoetin alfa - Early Communication about an Ongoing Safety Review (September 23)
FDA has been made aware of preliminary safety findings from a clinical trial conducted in Germany investigating the use of epoetin alfa to treat acute ischemic stroke.
FDA Updates Health Information Advisory on Melamine Contamination (September 26)
FDA is alerting consumers that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible contamination with melamine.
FDA Releases its Fourth Issue of the FDA Drug Safety Newsletter (September 23)
This publication provides postmarketing information to healthcare professionals to enhance communication of new drug safety information, raise awareness of reported adverse events, and stimulate additional adverse event reporting.
The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism (September 15)
Acting Surgeon General Steven K. Galson, M.D., M.P.H., issued a Call to Action to reduce the number of cases of deep vein thrombosis and pulmonary embolism in the United States.
UPCOMING MEETINGS:
Over the Counter Cough and Cold Medications for Pediatric Use
DATE AND TIME: October 2, 8:00 a.m.
LOCATION: Sheraton Washington North Hotel, 4095 Powder Mill Road, Beltsville, MD.
CONTACT: Faith Dugan, FDA, 301-796-3446.
FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance
DATE AND TIME: October 2-3, 2008, 8:00 a.m.
LOCATION: Hilton Wash. DC North/ Gaithersburg, 620 Perry Pkwy, Gaithersburg, MD 20877
CONTACT: Megan Moynahan, 240-276-8707.
Endocrinologic and Metabolic Drugs Advisory Committee
DATE AND TIME: October 21, 8:00 a.m.
LOCATION: Crowne Plaza Hotel, Washington DC-Silver Spring, 8777 Georgia Ave.,
Silver Spring, MD, (301) 589-0800
CONTACT: Paul Tran, R.Ph., 301-827-7001.
Peripheral and Central Nervous System Drugs Advisory Committee
DATE AND TIME: October 23, 8:00 a.m.
LOCATION: Hilton Washington DC, Silver Spring, The Ballrooms, 8727 Colesville Road,
Silver Spring, MD
CONTACT: Diem-Kieu Ngo, 301–827–7001
Joint Meeting of the Antiviral Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee
DATE AND TIME: October 29, 8:00 a.m.
LOCATION: Hilton The Ballrooms, 1750 Rockville Pike, Rockville, MD.
CONTACT: Paul Tran, Center for Drug Evaluation and Research, 301-827-6793.
Structured Product Labeling Content of Labeling and Electronic Drug Establishment Registration and Drug Listing for the Biologics Industry
DATE AND TIME: November 17, 8:30 a.m.
LOCATION: Universities at Shady Grove, Multipurposes Room, Building II, 9630 Gudelsky Dr., Rockville, MD.
CONTACT: Donna Lipscomb, Center for Biologics Evaluation and Research, 301-827-2000.
For notice of advisory committee meetings posted on earlier Health Professional communications additional information can be found after the meeting has been held. For information such as presentations, transcripts and voting results, please see FDA's Advisory Committee page.
RESOURCES:
The FDA the Week: Andy's Take (September 26, 2008)
Commissioner for Food and Drugs Andrew von Eschenbach discusses weekly FDA issues of interest to the American consumer and occasionally preview upcoming FDA issues and events. Featured this week is "Nutrition: Your Prescription for Health."
If you have any questions, you may send an email to webmail@oc.fda.gov or contact us at the numbers listed below.
Sincerely,
Janelle Derbis, PharmD
312-596-6516 (Chicago)
Brenda L. Evelyn, SBB(ASCP)
Brenda.evelyn@.fda.hhs.gov
301-827-4460
Heidi Marchand, PharmD
301-827-4460
Update : 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 16:03:15 -0500 (CDT)
Subject: Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)
Mr. Brown 3-In-1 and and 2-In-1 Powdered Packets in Bag Coffee Mixes Due To Health Risk (October 1)
Wed, 01 Oct 2008 16:01:00 -0500
The recall was initiated after the manufacturer notified Sunny Maid that these 3-in-1 and 2-in-1 Coffee Mix products may contain melamine. Although only certain lots are potentially contaminated, Sunny Maid is recalling all lots. No illnesses associated with this product have been reported to date.
Update : 10
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 16:04:35 -0500 (CDT)
Subject: FDA MedWatch - The October 2008 FDA Patient Safety News Video is now available...
  |
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 list serve. 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 October 2008 edition include:
Warning on Tendon Injuries with Fluoroquinolone Antibiotics
Boxed warning and Medication Guide needed to draw attention to the risk of tendon rupture and tendinitis with fluoroquinolone drugs such as Cipro…
CT Scanning May Cause Malfunction of Electronic Medical Devices
X-rays emitted during CT exams could adversely affect insulin pumps, neurostimulators, pacemakers, defibrillators…
Update on Cardiopulmonary Reactions with Ultrasound Micro-bubble Contrast Agents
Contrast agents Definity and Optison are no longer contraindicated for patients with unstable cardiopulmonary status; however, these high risk patients should be closely monitored…
Avoiding Cardiotoxicity with Mitoxantrone
The importance of monitoring LVEF during and after treatment with mitoxantrone…
Serious Complications from Using Recombinant Bone Morphogenetic Protein in the Cervical Spine
The safety and effectiveness of rhBMP in the cervical spine have not been demonstrated, and FDA has not approved it for this use…
Potentially Fatal Glucose Monitoring Errors with Icodextrin
Some point-of-care glucose meters use a type of test strip that can't distinguish between glucose and other sugars…
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
Update : 11
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 1 Oct 2008 17:03:33 -0500 (CDT)
Subject: Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
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Drug Shortages: Drugs to be Discontinued; SecreFlo (porcine secretin for injection, 16 mcg/vial)
Fri, 26 Sep 2008 08:45:00 -0500
See Web site for additional information
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