FDA News Digest for December 22, 2003

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FDA News Digest

December 22, 2003

Note to Subscribers:

FDA News Digest is taking a holiday break the week of Dec. 29. We wish all

our subscribers happy holidays, and we'll return to your e-mailbox Jan. 5.

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DNA Tests Approved for Gauging Risk of Blood Clotting Abnormalities

FDA has approved two test kits that will allow clinical laboratories to

identify people at risk of developing blood clots in the veins of their legs

and elsewhere because of hereditary clotting abnormalities. The products are

the first DNA-based lab tests for an inherited disorder.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00998.html

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Doctors Updated on Risks Related to Abdominal Aneurysm Stent

Emphasizing that AneuRx Stent Grafts " remain safe and effective, " FDA has

updated earlier information about the mortality risk associated with use of

these stents, used to prevent rupture of abdominal aortic aneurysms.. Based

on clinical trial results, FDA estimates a 2.7 percent aneurysm-related

death rate three years after patients were implanted with the stent.

Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01272.html

Public health notification: http://www.fda.gov/cdrh/safety/aneurx.html

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Health Professionals Alerted About Counterfeit Hernia Repair Mesh

FDA is alerting health professionals about a counterfeit version of the

Prolene polypropylene mesh, used in hernia repair and other surgery.

Preliminary testing has shown that some samples are not sterile. The agency

hasn't determined if the counterfeit devices are still being marketed.

Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01274.html

Public health notification: http://www.fda.gov/cdrh/safety/121903.html

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FDA Issues Tips for Preventing Hospital Bed Fires

FDA has issued a list of tips for hospitals and other medical facilities to

help prevent fires in electrically powered hospital beds. The agency has

received 95 reports of hospital bed fires since 1993.

Press release: http://www.fda.gov/bbs/topics/ANSWERS/2003/ANS01273.html

Safety tip list: http://www.fda.gov/cdrh/safety/bedfires.html

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13 Indicted in land Oxycontin Drug Trafficking Ring

Following a two-year investigation by FDA and several other federal, state

and local agencies, a federal grand jury has indicted 13 people on charges

that they used fraudulent prescriptions to obtain Oxycontin and other

prescription drugs from land pharmacies for resale on the street.

http://www.fda.gov/bbs/topics/NEWS/2003/dojoxycontinprfinal.pdf

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Pet Turtles Pose Salmonella Risk for Infants and Small Children

FDA is urging consumers not to buy live baby turtles with a shell less than

four inches long because they could put infants and small children at risk

of salmonella infection. Though FDA banned sales of these turtles in 1970,

the agency has learned that malls in the Houston area have been selling

them.

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00997.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.

Betty Crocker Triple Chunk Brownie Mix; limited number of 21.2 oz. packages

(undeclared pecans)

http://www.fda.gov/oc/po/firmrecalls/generalmills12_03.html

Country Dairy Eggnog (possible inadequate processing)

http://www.fda.gov/oc/po/firmrecalls/countrydairy12_03.html

Hansen Beverage Co. Classic Sparkling Cider; 50.7 oz. Magnum glass bottles

(some bottles broken)

http://www.fda.gov/oc/po/firmrecalls/hansen12_03.html

Hood Cultured Fat-Free Buttermilk (undeclared eggs)

http://www.fda.gov/oc/po/firmrecalls/hood12_03.html

Sedef Bakery Baklava, Sesame Sticks, Assorted Cookies, and Kurupasta

(undeclared nuts, dairy products and eggs)

http://www.fda.gov/oc/po/firmrecalls/sedef12_03.html

Peregrina Queso Fresco Fresh Cheese (possible Listeria contamination)

http://www.fda.gov/oc/po/firmrecalls/peregrina12_03.html

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RECENT SPEECHES

FDA Commissioner Mark B. McClellan, M.D., before the European Federation for

Pharmaceutical Sciences Conference, Basel, Switzerland (Dec. 8)

http://www.fda.gov/oc/speeches/2003/eufeps1208.html

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PUBLIC MEETINGS

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

to

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

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HOW'S YOUR KNOWLEDGE of health-related topics such as heart disease,

genetically engineered foods, and menopausal hormone therapy? Find out by

taking our quiz at http://www.fda.gov/fdac/quiz/onlinequiz14_js.html.

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