FDA News Digest for June 5, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

June 5, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Withdrawn MS Drug Tysabri Can Be Marketed with Restrictions

    -- Report Suggests Ways to Manage Calories Away from Home

    -- Latest 'Patient Safety News' Video Available Free Online

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Withdrawn MS Drug Tysabri Can Be Marketed with Restrictions

FDA has approved an application that will allow withdrawn multiple sclerosis drug Tysabri to be marketed again. The drug was initially approved in 2004 but taken off the market in 2005 after three patients in clinical trials developed progressive multifocal leukoencephalopathy (PML), a rare brain infection. FDA is allowing the drug to be reintroduced with a patient registration program designed to minimize PML risks.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01380.html

 

Report Suggests Ways to Manage Calories Away from Home

A report produced for FDA offers recommendations to improve the ability of consumers to manage calorie intake from foods prepared and bought away from home. Called the "Keystone Report," the document is part of FDA efforts to help reduce overweight/obesity, poor nutrition, and physical inactivity. The agency says Americans spend about 46 percent of their food budget on items prepared away from home and take in about 32 percent of their calories from such foods.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01379.html 

-- Keystone Report text: http://www.keystone.org/spp/documents/Forum_Report_FINAL_5-30-06.pdf

 

Latest 'Patient Safety News' Video Available Free Online

FDA has posted the latest edition of "Patient Safety News," a free Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm

 

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 Safety Alert: 

 

Georgia health officials report that Caribbean Dreams Cerasee Tea has tested positive for Salmonella bacteria. Though the tea is being removed from store shelves, officials urge consumers who have the tea at home to return it to the place of purchase.

http://www.fda.gov/oc/po/firmrecalls/cerasee05_06.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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UPCOMING PUBLIC MEETINGS

June 6-7 -- Food Safety and Defense Workshop

    Under discussion: current Good Manufacturing Practice regulations for foods and other topics of interest to regulated industry, especially small businesses

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-4366.htm

 

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

 

Who performs liposuction and where is it performed?

 

Many liposuction surgeries -- procedures intended to remove fat deposits and shape the body -- are performed by plastic surgeons or dermatologists. Any licensed physician may perform liposuction. While professional societies may recommend training before performing liposuction surgery, no standardized training is required. As a result, there will be differences in experience and training in physicians performing liposuction.

 

You can ask your physician to tell you whether he or she has had specialized training to do liposuction or has successfully done liposuction before. But remember, even the best screened patients under the care of the best trained and experienced physicians may experience complications as a result of liposuction.

 

Liposuction may be performed in a doctor's office, surgical center, or hospital. Because liposuction is a surgical procedure, it is important that it be performed in a clean environment. Emergencies may arise during any surgery and access to emergency medical equipment or a nearby hospital emergency room is important.  

 

For more information on liposuction, see http://www.fda.gov/cdrh/liposuction/.

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Hey, kids! Take our fun poll! We want to know your favorite place to have a picnic. Is it the park? The beach? How about your own backyard? Go to http://www.fda.gov/oc/opacom/kids/default.htm and let us know!

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       To learn more about FDA's 100th birthday,

     go to http://www.fda.gov/centennial/default.htm