FDA News Digest for April 2, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

April 2, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Maker of IBS Drug Zelnorm to Voluntarily Stop Marketing It

    -- Pergolide Products, Used to Treat Parkinson's, to be Withdrawn

    -- FDA Approves First Biologic Treatment for Rare Clotting Disorder

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Maker of IBS Drug Zelnorm to Voluntarily Stop Marketing It

The manufacturer of Zelnorm --a treatment for irritable bowel syndrome and chronic constipation -- is voluntarily discontinuing marketing of the drug following a recent discovery of an increased risk of serious heart problems linked to use of the drug. FDA urges patients taking the drug to contact their health care providers to discuss treatment alternatives.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01597.html

 

Pergolide Products, Used to Treat Parkinson's, to be Withdrawn

Makers of pergolide products, used to treat Parkinson's disease, will voluntarily remove these drugs from the market due to the risk of serious damage to heart valves. Drugs to be withdrawn include the brand-name drug Permax and generic drugs made by Par and Teva.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01596.html

 

FDA Approves First Biologic Treatment for Rare Clotting Disorder

FDA has licensed Ceprotin, the first biologic treatment for Protein C deficiency, a rare genetic defect that can cause a potentially life-threatening clotting disorder. The deficiency is found in one to two newborns for every million births.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01598.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

Pet Food Recall:

 

Two lots and sizes of Prescription Diet m/d Feline dry cat food

    Reason for recall: FDA testing found melamine in wheat gluten used to make the dry cat food

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01599.html

Note: FDA has a special page with the latest information on what brands of pet food are being recalled at http://www.fda.gov/oc/opacom/hottopics/petfood.html

 

Food Recalls:

 

Chiu Chow Fish Paste, Fish Ball, and Fish Cake products, various sizes

    Reason for recall: undeclared egg

http://www.fda.gov/oc/po/firmrecalls/southeast03_07.html

 

Cerignola, Nocellara, and Castelvetrano olives, various sizes

    Reason for recall: possible contamination with Clostridium botulinum

http://www.fda.gov/oc/po/firmrecalls/charliebrown03_07.html

 

Various Corner vegetarian sandwiches and salads (sold in New York City and New Jersey)

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/healthycorner03_07.html

 

Various types of Lorenzo's brand Mexican breads

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/lorenzo03_07.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

 

March 26-- FDA Deputy Commissioner and Chief Medical Officer Janet Woodcock, M.D., appeared before the House Committee on Oversight and Government Reform.

    Subject: "Follow-On Protein Products"

http://www.fda.gov/ola/2007/protein32607.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

 

April 10-11 -- Food Labeling Workshop (jointly sponsored by FDA and the University of Arkansas)

    Under discussion: FDA food labeling regulations, especially as they relate to small businesses and startups

    Location: Fayetteville, Ark.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-1570.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 hay fever?

Hay fever (pollen allergy) is one of the most common kinds of allergies. About 35 million Americans suffer from it. Pollen is made by trees, grasses and weeds. During the spring, summer and fall, some plants release pollen into the air. Hay fever symptoms might be different at different times of the year. It depends on the kinds of plants that grow where you live and what allergies you have. Symptoms include:

·       

»   » Sneezing

» Runny or clogged nose

» Coughing

» Itchy eyes, nose, and throat

» Watery eyes

» Red, swollen eyes

          

            No one is sure what causes allergies. You are more likely to have hay fever if your parents have it.

 

Your doctor can help you decide what to do, which may include avoiding the things that cause your symptoms, using medicines, or getting allergy shots.

 

For more information on hay fever or allergies, see http://www.fda.gov/womens/getthefacts/allergies.html.

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