FDA News Digest for December 18, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

________________________________________________________

 

Note to Subscribers:

 

FDA News Digest is taking a holiday break the week of Dec. 25. We'll return

to your e-mailbox on Jan. 2.

 

We wish all our subscribers happy holidays and a great 2007! 

________________________________________________________

 

FDA News Digest

December 18, 2006

__________________________________________________________

 

IN THIS WEEK'S ISSUE

 

»  News

    -- E. Coli Outbreak in Northeastern States Reportedly Ended

    -- First Generic Version of Depression Treatment Wellbutrin OK'd

    -- Treatment Approved for Potential Chemical Agent Cyanide

    -- Celebrex Now Approved for Juvenile Rheumatoid Arthritis

    -- Test Screens Donors for Parasite That Causes Chagas Disease

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

____________________________________________

 

NEWS

 

E. Coli Outbreak in Northeastern States Reportedly Ended

The outbreak of E. coli O157:H7 infection that sickened 71 people after they ate at Taco Bell restaurants in Northeastern states "has ended," says the Centers for Disease Control and Prevention. FDA officials now suspect iceberg lettuce as the likely source of the outbreak.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01527.html

 

First Generic Version of Depression Treatment Wellbutrin OK'd

FDA has approved the first generic version of Wellbutrin XL (bupropion hydrochloride) Extended-Release Tablets, a treatment for major depressive disorder. Generic drugs, used to fill over half of all prescriptions, cost a fraction of the price of brand-name drugs. 

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01526.html

 

Treatment Approved for Potential Chemical Agent Cyanide

FDA has approved the Cyanokit to treat known or suspected cyanide poisoning. The approval is a measure to help improve response to emergencies, including a possible terrorist attack.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01531.html

 

Celebrex Now Approved for Juvenile Rheumatoid Arthritis

FDA has approved the anti-inflammatory drug Celebrex as a treatment for juvenile rheumatoid arthritis in patients aged 2 and older. The disease, which affects as many as 60,000 children in the United States, is associated with joint swelling, pain, decreased range of motion, and growth and development abnormalities. Celebrex was first approved in 1998 to treat rheumatoid arthritis and osteoarthritis in adults.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01530.html

 

Test Screens Donors for Parasite That Causes Chagas Disease

FDA has approved a new test to screen blood donors for a parasite that causes Chagas Disease. An estimated 11 million people are infected with the parasite, T. cruzi, most commonly in Mexico and Central and South America. Concerns about Chagas Disease have heightened due to the increasing number of U.S. residents who previously lived in countries where the disease is common.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01524.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.]

____________________________________________

 

RECALLS/SAFETY ALERTS

Food Recalls:

 

Certain lots of Ragu Pasta Sauce, Old World Style, Marinara, 26 oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/unilever12_06.html

 

Kellogg's Frosted Blueberry Pop-Tarts, 8 oz. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/poptarts12_06.html

 

1,100 cases of raw oysters from Fortuna Sea Products

    Reason for recall: possible norovirus contamination

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01522.html

 

Medical Device Recall:

 

Systane Free Liquid Gel lubricant eye drops

    Reason for recall: possible presence of foreign material

http://www.fda.gov/oc/po/firmrecalls/alcon12_06.html

 

Safety Alerts:

 

Following a study linking the drug Trasylol to an increased risk of kidney failure, heart attack, or stroke, FDA has approved revised labeling for the drug aimed at strengthening warnings and limiting usage to specific situations. Trasylol is given before heart surgery to reduce bleeding and the need for blood transfusions.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01529.html

 

(Note: This item is updated from an earlier posting) 

FDA is warning consumers not to use counterfeit blood glucose test strips being sold with various models of One Touch brand blood glucose monitors. The counterfeit strips -- certain lot numbers of One Touch Basic Profile and One Touch Ultra -- could give incorrect readings, potentially leading to serious injury or death. For the latest list of lot numbers, and for more information, see http://www.fda.gov/bbs/topics/NEWS/2006/NEW01528.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.]

_____________________________________________

 

UPCOMING PUBLIC MEETINGS

Jan. 9 -- Public Workshop on Marketed Unapproved Drugs

    Under discussion: how businesses can obtain FDA approval to legally market currently unapproved drug products

    Location: Rockville, Md.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01500.html

-- Federal Register notice: http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17959.htm

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

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

__________________________________________________

 

QUESTION OF THE WEEK

 

What information must a manufacturer disclose on the label of a dietary supplement?

FDA regulations require certain information to appear on dietary supplement labels, including:

•  a descriptive name of the product, stating that it is a "supplement"
•  the name and place of business of the manufacturer, packer, or distributor
•  a complete list of ingredients
•  the net contents of the product.

In addition, each dietary supplement -- except for some small-volume products or those produced by eligible small businesses -- must have nutrition labeling in the form of a "Supplement Facts" panel. This label must identify each dietary ingredient contained in the product.

For more on dietary supplements, see http://www.cfsan.fda.gov/~dms/supplmnt.html. __________________________________________________

Thanks for subscribing to FDA News Digest. Our next issue will be sent January 2.

 

Comments about FDA News Digest? Send an e-mail to fdanewsdigest@xxxxxxxxxv.

 

To subscribe to or unsubscribe from this list, go to

http://list.nih.gov/cgi-bin/wa?SUBED1=fda-newsdigest-l&A=1.

__________________________________________________

 

 

       To learn more about FDA's 100th birthday,

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