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
-- 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.
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)
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.)
For a list of FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html
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