RECALLS - FDA News Digest for March 14, 2005

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FDA News Digest

March 14, 2005

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IN THIS WEEK'S ISSUE

 

-- Potential Cancer Risk Prompts FDA Advisory on 2 Eczema Drugs

-- FDA Offers Patient Information on Recently Approved Devices

-- FDA Web Site Receives 'Silver' Award in Health Information Contest

-- Latest FDA Consumer Magazine Available Online

-- Recalls/Market Withdrawals

-- Recent Speeches

-- Public Meetings

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Potential Cancer Risk Prompts FDA Advisory on 2 Eczema Drugs

 

Following findings of a potential cancer risk associated with the eczema treatments Elidel and Protopic, FDA is advising healthcare professionals to prescribe the drugs only as directed and only after other eczema treatments have failed. The agency also is adding a "black box" warning to the labeling of both drugs and is developing a medication guide for patients.

-- Press release: http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01343.html

-- Public health advisory: http://www.fda.gov/cder/drug/advisory/elidel_protopic.htm

 

FDA Offers Patient Information on Recently Approved Devices

 

FDA's Center for Devices and Radiological Health has published 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.

-- Advia Centaur HCV Assay (for diagnosing hepatitis C virus): http://www.fda.gov/cdrh/mda/docs/p030056.html

-- Reflection Ceramic Acetabular System (an artificial hip replacement system): http://www.fda.gov/cdrh/mda/docs/p030022.html

-- InSite Her-2/neu kit (identifies breast cancer patients eligible for treatment with the drug Herceptin): http://www.fda.gov/cdrh/mda/docs/p040030.html

 

FDA Web Site Receives 'Silver' Award in Health Information Contest

 

FDA's Web site (www.fda.gov) has received a "Silver" award in the Fall/Winter 2004 World Wide Web Health Awards competition. The semiannual contest is sponsored by the Health Information Resources Center (HIRC), a clearinghouse for consumer health information. The awards act as a "seal of approval" for health-related Web sites aimed at consumers and health professionals, HIRC says.

http://www.fda.gov/bbs/topics/news/2005/NEW01164.html

 

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Latest FDA Consumer Magazine Available Online

 

The March-April 2005 issue of FDA Consumer has articles on the following topics:

 

-- Stroke -- The latest information on the third-leading cause of death for Americans.

-- Arthritis -- Advice on managing the crippling pain and inflammation of this disorder.

-- "PillCam" -- This new tool takes snapshots of the digestive system.

-- Teen tanning -- FDA discourages the use of tanning devices.

-- Radiofrequency identification -- Electronic tags can track drugs through the distribution process.

-- Dietary guidelines -- The latest federal advice stresses calorie control and exercise.

-- FDA Science Forum -- A free consumer session in Washington, D.C., April 26 will discuss personalizing your healthcare.

 

The issue is online at http://www.fda.gov/fdac/205_toc.html.

Subscribe to FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html.

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RECALLS/MARKET WITHDRAWALS

 

The following products are being recalled for the reasons shown. Go to the linked page for more information.

 

Deli Express Turkey & Cheese Sandwiches (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/EASween03_05.html

 

Kien Import Frozen Cooked Mackerel Fish (possible contamination with Clostridium botulinum spores)

http://www.fda.gov/oc/po/firmrecalls/kienimport03_05.html

 

 

For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated products from the last 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

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RECENT SPEECHES

 

FDA Acting Commissioner Lester M. Crawford, D.V.M., before the U.S. Pharmacopeia Convention (March 11)

http://www.fda.gov/oc/speeches/2005/pharmacopeia311.html

 

To view an archive of past speeches by FDA officials, go to http://www.fda.gov/speeches/speechli.htm

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PUBLIC MEETINGS

 

 

March 15 -- FDA Vaccines and Related Biological Products Advisory Committee; under discussion: safety and immunogenicity of two tetanus diphtheria and pertussis vaccines (Bethesda, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cber12391d031505.html

 

March 17-18 -- FDA Blood Products Advisory Committee; under discussion: transmissible spongiform encephalopathies, West Nile virus, and FDA's Critical Path Initiative (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cber19516dd03171805.html

 

March 21-22 -- FDA/New Mexico University Food Labeling Public Workshop; intended to provide information about FDA food labeling regulations and other related subjects to regulated industry, especially small businesses and startups (Las Cruces, N.M.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2450.htm

 

March 21 -- Public hearing on reporting adverse events to institutional review boards (Rockville, Md.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2300.htm

 

March 23 -- FDA Nonprescription Drugs Advisory Committee; under discussion: processes used to demonstrate the effectiveness of antiseptic products in health care settings (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12541d032305.html

 

March 24 -- Joint meeting of the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee; under discussion: evaluating the switch of topical corticosteroids from prescription to over-the-counter status (Gaithersburg, Md.)

http://www.fda.gov/oc/advisory/accalendar/2005/cder12534d032405.html

 

April 5-6 -- Animal Feed Safety System: A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds; a forum for comments on a safety program designed to minimize public health hazards posed by animal feed products (Omaha, Neb.)

http://www.fda.gov/cvm/index/animalfeed/AFSSMtg/AFSSMtg042005.htm

 

April 5-6 -- FDA/University of Arkansas workshop on food labeling; intended to provide information about FDA food labeling regulations and related subjects to regulated industry, especially small businesses and startups (Fayetteville, Ark.)

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-2299.htm

 

 

For a list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html