FDA News Digest
July 25, 2005
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IN THIS WEEK'S ISSUE
-- Four Reported Deaths Prompt FDA Warning About Mifeprex
-- FDA Offers Patient Information on Recently Approved Devices
-- Recalls/Safety Alerts
-- Congressional Testimony
-- Public Meetings
-- Question of the Week
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Four Reported Deaths Prompt FDA Warning About Mifeprex
FDA is investigating reports of four deaths over the last two years associated with the medical abortion drug Mifeprex (mifepristone or RU-486). As a result, the agency has issued a public health advisory highlighting the risk of sepsis or blood infection when the drug is used in a way inconsistent with its labeling.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01207.html
-- More information: http://www.fda.gov/cder/drug/infopage/mifepristone/default.htm
FDA Offers Patient Information on Recently Approved Devices
FDA's Center for Devices and Radiological Health has published online consumer information on three recently approved medical devices. The information, linked on the following list, briefly describes the devices, explains what they are intended to do, and tells how they should and should not be used:
-- VNS Therapy System (implanted device to treat depression)
http://www.fda.gov/cdrh/mda/docs/p970003s050.html
-- Rithron-XR Coronary Stent System (to open narrowed coronary arteries)
http://www.fda.gov/cdrh/mda/docs/p030037.html
-- AcrySof ReSTOR Apodized Diffractive Posterior Chamber Intraocular Lens (to restore vision after a cataract is removed)
http://www.fda.gov/cdrh/mda/docs/p040020.html
To view an archive of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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RECALLS/SAFETY ALERTS
Recalls:
Guidant Corporation; pacemakers
Reason for recall: hermetic sealing component used in these devices may gradually degrade, possibly leading to device failure. http://www.fda.gov/bbs/topics/NEWS/2005/NEW01210.html
All models of Baxter Healthcare's Colleague Volumetric Infusion Pumps
Reason for recall: units can shut down while delivering medication and fluids to patients
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01209.html
Imperial Salmon House, Superior brand Norwegian Cure, and Golden Eagle Smoked Salmon; various sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01208.html
Golden Taste Nova Lox Salad; various sizes
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/goldentaste207_05.html
Arnold Vending brand Sausage Gravy & Biscuit; 8-oz. size
Reason for recall: undeclared eggs
http://www.fda.gov/oc/po/firmrecalls/arnold07_05.html
About 838,000 boxes of Pure Milk Chocolate Covered Oreo Sandwich Cookies; 7.5-oz. size
Reason for recall: some units contain undeclared peanuts
http://www.fda.gov/oc/po/firmrecalls/nabisco207_05.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the past 60 days, go to
http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
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CONGRESSIONAL TESTIMONY
FDA Center for Food Safety and Applied Nutrition Director Robert E. Brackett, Ph.D., appeared before the Senate Committee on Agriculture, Nutrition and Forestry.
Subject: FDA's counterterrorism activities to enhance protection of the food supply
http://www.fda.gov/ola/2005/counterterrorism0720.html
To view an archive of past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html.
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PUBLIC MEETINGS
July 29 -- Cellular, Tissue and Gene Therapies Advisory Committee
Under discussion: pertinent FDA research programs
Location: Rockville, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d072905.html
Aug. 4 -- Peripheral and Central Nervous System Drugs Advisory Committee
Under discussion: an application for a new drug to treat migraine headaches
http://www.fda.gov/oc/advisory/accalendar/2005/cder12543d080405.html
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
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QUESTION OF THE WEEK
Are food additives necessary and are they safe?
Yes, food additives are necessary. Without them, food spoilage, food costs, and the loss of food to pests would be higher. FDA evaluates all food additives for safety before they are allowed in foods and has found them to be safe and effective in the quantities in which they are consumed in foods.
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