FDA News Digest

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest

FDA News Digest

April 21, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Approves the HeartMate II, First Compact Heart-Assist Device

    -- Hazardous Selenium Levels Found in Samples of Two Dietary Supplements

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

FDA Approves the HeartMate II, First Compact Heart-Assist Device

FDA has approved the Thoratec HeartMate II Left Ventricular Assist System, a first-of-its-kind heart-assist device that is only three inches in length and weighs about one pound.. It uses a continuous flow pump that constantly moves blood with a single moving part, a spinning rotor. Previous heart-assist device models were too large to be placed in the upper abdomen of some women and small-sized men. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01820.html

 

Hazardous Selenium Levels Found in Samples of Two Dietary Supplements

FDA has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." The agency has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. Selenium, a naturally occurring mineral, is needed only in very small amounts for good health. Excessive intake of selenium is known to cause symptoms that include significant hair loss, muscle cramps, diarrhea, joint pain, fatigue, loss of fingernails and blistering skin.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01818.html 

 

To view an archive of recent 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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SAFETY ALERTS/RECALLS

Food Recall:

 

›  KFC Double Chocolate Chip Cakes, distributed at KFC restaurants nationwide

Reason for recall: egg, wheat, soy, milk, and possibly tree nut ingredients not labeled

http://www.fda.gov/oc/po/firmrecalls/kfc04_08.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

 

April 24-25 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application to market an implantable miniature telescope

    Location: Gaithersburg, Md.

http://edocket.access.gpo.gov/2008/E8-5810.htm

 

April 29-30 -- Public Workshop on Safety of Hemoglobin-Based Oxygen Carriers

    Location: Bethesda, Md.

http://www.fda.gov/cber/meetings/hboc042908.htm

For a complete list of meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

 

 

CONSUMER HEALTH INFORMATION

 

In the spotlight this week:

 

›  Find the Latest Drug Product and Safety Information

http://www.fda.gov/consumer/updates/druginfo041108.html

›  A Guide to Drug Safety Terms at FDA

http://www.fda.gov/consumer/updates/drugterms041108.html

 

To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html 

 

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Our next issue will be sent April 28.

 

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