FDA News Digest for September 25, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

September 25, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- Illness Cases and Affected States Increase in Spinach-Related Outbreak

    -- FDA Acting Commissioner Comments on Independent Drug Safety Report

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Illness Cases and Affected States Increase in Spinach-Related Outbreak

To date, 173 cases of infection with the dangerous bacterial strain E. coli O157:H7 have been reported in an outbreak related to spinach grown in three coastal California counties. Officials confirm that the reported cases include one death, 27 instances of kidney failure, and 92 hospitalizations. FDA continues to warn consumers not to eat fresh spinach grown in Monterey, San Benito, or Santa Clara Counties. However, fresh spinach known to be grown outside the implicated counties, as well as canned and frozen spinach, is safe to eat, FDA says. If in doubt about where the spinach was grown, avoid it, the agency says.

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01464.html

-- More information: http://www.fda.gov/oc/opacom/hottopics/spinach.html

-- Questions and answers (English): http://www.cfsan.fda.gov/~dms/spinacqa.html

-- Questions and answers (Spanish): http://www.cfsan.fda.gov/~dms/sspinaqa.html 

 

FDA Acting Commissioner Comments on Independent Drug Safety Report

The Institute of Medicine, a non-profit organization that gives science-based advice on health matters, has released a report based on a study FDA commissioned to review drug safety and provide recommendations on how to best ensure in the future that prescription drugs are safe and effective. FDA Acting Commissioner Andrew C. von Eschenbach, M.D., says the agency "will evaluate the report and take necessary steps."

-- FDA statement: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01461.html

-- FDA New Drug Safety Initiative: http://www.fda.gov/cder/drugSafety.htm

-- Fact sheet on Drug Safety Initiative: http://www.fda.gov/oc/factsheets/initiative.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: 

 

Certain lots of Various brands of nacho tortilla chips distributed by Wise Foods Inc.

    Reason for recall: undeclared soy

http://www.fda.gov/oc/po/firmrecalls/wise09_06.html

 

Various flavors of Dragonfly brand puddings, various sizes

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/ustrading09_06.html

 

Nasutra dietary supplement, marketed as a male performance enhancer

    Reason for recall: product contains acetildenafil, which is related to the active ingredient in Viagra

http://www.fda.gov/oc/po/firmrecalls/nasutra09_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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CONGRESSIONAL TESTIMONY

Sept. 21 -- FDA Associate Commissioner for Science Norris E. Alderson, Ph.D., appeared before the House Committee on Science.

    Subject: nanotechnology

http://www.fda.gov/ola/2006/nanotechnology0921.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

 

Sept. 26 -- Risk Communication on Medical Devices: Sharing Perspectives

    Under discussion: how the government and device industry communicate expected and unexpected risks to doctors, patients and the public

    Location: North Bethesda, Md.

http://www.fda.gov/cdrh/meetings/092606-riskcommunication.html

 

Sept. 28 -- National Mammography Quality Assurance Advisory Committee

    Under discussion: amendments to current mammography regulations

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12569.htm

 

Oct. 4 -- Joint meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Advisory Committee for Pharmaceutical Science

    Under discussion: the quality of currently marketed levothyroxine sodium drug products

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11471.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

 

What is sleep apnea and how is it treated?

 

Snoring loud and often, together with too much daytime sleepiness, may be signs of sleep apnea, a very common sleep disorder that can also be dangerous. The most common type of sleep apnea happens when your breathing stops during sleep. It can stop for about 10 seconds to as long as a minute. You wake up trying to breathe. This stop-and-start cycle of waking to breathe can repeat hundreds of times a night. The danger is that some time you may not wake up to breathe. If this happens, you can die.

 

You are likely to feel sleepy during the day if you have this problem. People with sleep apnea tend to be overweight. It is more common among men than women.

 

Sleep apnea is usually treated this way:

 

» The most common treatment is a device called continuous positive airway pressure (CPAP) that pushes air through the airway.

» Avoid beer, wine, liquor, tobacco, and sleeping pills.

» Your doctor may suggest that you lose weight.

» In some cases, you may need surgery to make the airway bigger.

 

For more information on sleep disorders, see http://www.fda.gov/womens/getthefacts/sleep.html.

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