FDA News Digest for March 21, 2005

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Title: Message

FDA News Digest

March 21, 2005

 

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IN THIS WEEK'S ISSUE

 

--  New Drug Symlin Approved for Blood Sugar Control in Diabetics

--  Temodar Approved for New Use in Treating Common Brain Cancer

--  TB Cases Prompt Advisory About Soft Cheese Made From Raw Milk

--  Recalls/Market Withdrawals

--  Congressional Testimony

--  Public Meetings

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New Drug Symlin Approved for Blood Sugar Control in Diabetics

 

FDA has approved the injectable drug Symlin for use with insulin therapy in adult patients with type 1 or type 2 diabetes who cannot adequately control blood sugar with insulin alone. For type 1 diabetes patients, Symlin is the only approved therapy other than insulin; for type 2 patients, there are several other oral therapies. Symlin has not been evaluated for use in children.

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01345.html

 

Temodar Approved for New Use in Treating Common Brain Cancer

 

FDA has approved the drug Temodar (temozolomide) for a new use as a treatment for glioblastoma multiforme, the most common form of malignant brain cancer. In a recent clinical trial with 573 patients, median survival time increased by 2-1/2 months in those taking Temodar. The drug  originally approved in 1999 for treating anaplastic astrocytoma, another form of brain cancer.

http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01344.html

 

TB Cases Prompt Advisory About Soft Cheese Made From Raw Milk

 

FDA is advising that some soft cheeses made with raw milk present a health risk, especially to high risk groups, such as pregnant women, newborns, older adults, and people with weakened immune systems. Recently, cases of tuberculosis in New York City have been linked to consumption of queso fresco style cheeses, either imported from Mexico or consumed in Mexico.

http://www.fda.gov/bbs/topics/news/2005/NEW01165.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.

 

Samaritan Automatic External Defibrillators, models SAM-001, SAM-002, and SAM-003 with certain serial numbers within 1270 and 2324 (may shut down before delivering therapeutic shock, causing treatment delay or patient death)

http://www.fda.gov/oc/po/firmrecalls/heartsine03_05.html

 

One lot of Micotil 300, an antibiotic treatment for respiratory infections in cattle and sheep (client information sheet not included)

http://www.fda.gov/oc/po/firmrecalls/elanco03_05.html

 

One lot of PharMEDium Services magnesium sulfate solution (may be contaminated with Serratia marcescens bacteria)

http://www.fda.gov/bbs/topics/news/2005/NEW01166.html

 

Certain lots of Deli Express Turkey & Cheese Sandwiches (potential Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/sween03_05.html

 

Various Eastside Deli, Fresh From the Deli, and In Your Belly Deli products (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/eastsidedeli03_05.html

 

Van de Kamp Cinnamon Rolls (undeclared dairy allergen)

http://www.fda.gov/oc/po/firmrecalls/littlebros03_05.html

 

Hans Kissle tuna salad (possible Listeria monocytogenes contamination)

http://www.fda.gov/oc/po/firmrecalls/hanskissle03_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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CONGRESSIONAL TESTIMONY

 

FDA Acting Commissioner Lester M. Crawford, D.V.M., before the Senate Committee on Health, Education, Labor and Pensions; subject: confirmation hearing for Crawford's nomination as FDA commissioner (March 17)

http://www.fda.gov/ola/2005/confirmation0317.html

 

To view an archive of FDA congressional testimony, go to http://www.fda.gov/ola/listing.html

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PUBLIC MEETINGS

 

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

 

April 26-28 -- 11th Annual FDA Science Forum; includes a free public session April 26 on personalizing your healthcare; remaining two days are devoted to scientific sessions on nanotechnology, animal models, cancer diagnosis/treatment, risk management, and other topics (Washington, D.C.)

http://www.cfsan.fda.gov/~frf/forum05/sxsf05pr.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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