FDA News Digest for February 27, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

February 27, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Risk Management Plan for Accutane to Start March 1

    -- Supplements With Banned Ephedrine Alkaloids Seized  

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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Risk Management Plan for Accutane to Start March 1

Starting March 1, a strengthened risk management plan called iPLEDGE will inform women about the risk of becoming pregnant while taking the acne drug Accutane and its generics. Accutane has known potential serious side effects, including birth defects (when pregnant women take the drug) and an association with depression.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01324.html

 

Supplements With Banned Ephedrine Alkaloids Seized 

U.S. marshals have seized varying quantities of three different dietary supplements distributed by Georgia-based Hi-Tech Pharmaceuticals that contain prohibited ephedrine alkaloids. Studies have linked ephedrine alkaloids, which FDA banned from sale in dietary supplements in 2004, to serious adverse health effects, including heart attack and strokes.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01325.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

 

Food Recalls:

 

One lot of Gentlease powdered infant formula

    Reason for recall: metal particles in the product

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01323.html

 

Various types of apricot-filled butter cookies distributed by California-based Frederico's Bakery

    Reason for recall: undeclared sodium bisulfite

http://www.fda.gov/oc/po/firmrecalls/federico02_06.html

 

Certain lots of Choxie milk chocolate truffles, peanut butter balls, and caramel balls

    Reason for recall: undeclared peanuts

http://www.fda.gov/oc/po/firmrecalls/galerie02_06.html

 

Safety Alert:

 

FDA has updated information to healthcare professionals and patients regarding the risk of bacterial meningitis in children who have cochlear implants with a positioner. Cochlear implants are used to produce useful hearing sensations in people with severe-to-profound hearing loss. Recent research suggests that the meningitis risk in patients who have the implants with a positioner remains longer than two years past the date of implantation. None of the devices with a positioner have been implanted since July 2002.

    Public health notice: http://www.fda.gov/cdrh/safety/020606-cochlear.html

    Cochlear implant information: http://www.fda.gov/cdrh/cochlear/index.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

 

Feb. 16 -- FDA Acting Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Agriculture, Rural Development, FDA and Related Agencies Appropriations

    Subject: hearing on fiscal year 2007 budget

http://www.fda.gov/ola/2006/budget_hearing0216.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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UPCOMING PUBLIC MEETINGS

 

March 6 -- Anti-Infective Drugs Advisory Committee

    Under discussion: an application for a new drug to treat staphylococcus aureus bacteremia

    Location: Rockville, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12530d030606.html

 

March 7-8 -- Peripheral and Central Nervous System Drugs Advisory Committee

    Under discussion: risks, benefits, and risk management of the multiple sclerosis treatment Tysabri

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12543d030706amd.html

 

March 8 -- Behavior-Based Blood Donor Deferrals in the Era of Nucleic Acid Testing

    Under discussion: policy to protect the blood supply from transmissible diseases by deferring donors based on high-risk behavior

    Location: Bethesda, Md.

http://www.fda.gov/cber/meetings/nat030806.htm

 

March 9-10 -- Blood Products Advisory Committee

    Under discussion: topics include blood donor screening for West Nile virus and home-use HIV test kits

    Location: Gaithersburg, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cber19516dd03091006.html

 

April 18-20 -- 2006 FDA Science Forum; includes sessions on topics such as drug safety, obesity, avian flu, and non-invasive medical devices.

    Location: Washington, D.C.

http://www.fda.gov/scienceforum

 

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

 

Why should I use a food thermometer?

A food thermometer can help prevent foodborne illness by measuring the internal temperature of meat, poultry, and egg dishes. Using a food thermometer not only can keep you and your family safe from harmful food bacteria, but it also helps you avoid overcooking, giving you a safe and flavorful meal.

 

To learn more, go to www.foodsafety.gov/~fsg/fsthermy.html.  

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