FDA News Digest for May 29, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

May 29, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Oral Contraceptive Lybrel is First Approved for Continuous Use

    -- FDA Acts Against Unapproved Timed-Release Drugs With Guaifenesin

    -- 'Boxed Warning' Requested for Contrast Agents Used in MRIs

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

»  New Postings on FDA.gov

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NEWS

 

Oral Contraceptive Lybrel is First Approved for Continuous Use

FDA has approved Lybrel, the first continuous-use drug product for preventing pregnancy. Continuous contraception works the same way as traditional birth control pills in that it stops the body's monthly preparation for pregnancy by lowering the hormone levels that make pregnancy possible. But unlike other oral contraceptives, Lybrel is taken daily throughout the month, which ends regular menstrual periods.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01637.html

 

FDA Acts Against Unapproved Timed-Release Drugs With Guaifenesin

FDA plans to take action against companies that market unapproved drugs in timed-release dosage with guaifenesin, an ingredient commonly used in cough and cold medicines. About 20 companies make timed-release products with guaifenesin that are considered unapproved because they have not undergone FDA review. The agency is concerned about unapproved products because they may be unsafe, not work, have inadequate labeling, and be improperly manufactured.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01640.html

-- More information on unapproved drugs: http://www.fda.gov/cder/drug/unapproved_drugs/default.htm

 

'Boxed Warning' Requested for Contrast Agents Used in MRIs

FDA has asked manufacturers to include a "boxed warning" on the product labeling of gadolinium-based contrast agents, which are used to enhance the quality of magnetic resonance imaging. The warning would include a statement that patients with severe kidney insufficiency who receive the contrast agents are at risk of developing a debilitating, potentially fatal disease called nephrogenic systemic fibrosis.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01638.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

Device Recall:

 

›  Complete MoisturePlus Multi Purpose Solution for soft contact lenses

   Reason for recall: reports of rare eye infection Acanthamoeba keratitis

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01641.html

 

Food Recalls:

 

›  Certain lots of Manischewitz Sparkling Concord Grape Juice and Sparkling Niagara Grape Juice

   Reason for recall: some bottles have fermented, which could cause the cap to pop or the bottle to rupture

http://www.fda.gov/oc/po/firmrecalls/rab05_07.html

›  Certain lots and various sizes of Marantha Sesame Tahini

   Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/nspired05_07.html  

›  Monkfish distributed to wholesalers in Illinois, California and Hawaii by the Hong Chang Corp., 22-lb. boxes

    Reason for recall: may contain tetrodotoxin, a potent toxin

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01639.html

›  Three lots of Similac Special Care 24 Cal/fl. oz. Ready-to Feed Premature Infant Formula with Iron

    Reason for recall: does not contain as much iron as indicated on the label

http://www.fda.gov/oc/po/firmrecalls/abbott05_07.html

  ›   365 Organic Everyday Value Sesame Tahini, 16 oz. size (with "best by" date of 10/02/07 or earlier)

    Reason for recall: Possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/wholefoods05_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

 

May 22 -- FDA Office of New Drugs Deputy Director Sandra L. Kweder, M.D., appeared before the House Subcommittee on Health

    Subject: "Programs Affecting Safety and Innovation in Pediatric Therapies"

http://www.fda.gov/ola/2007/peds052207.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

 

June 11-12 -- 10th Annual FDA-Orange County Regulatory Affairs Educational Conference

    Location: Irvine, Calif.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-6052.htm

 

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

 

June 13 -- Endocrinologic and Metabolic Drugs Advisory Committee

    Under discussion: pending application for a drug treatment for obesity

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-5506.htm

 

 

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

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

 

 

QUESTION OF THE WEEK

 

Are there any foods that are exempt from federal nutrition labeling requirements? 

 

Yes. Under the Nutrition Labeling and Education Act of 1990, these foods are exempt from nutrition labeling:

 

»  food served for immediate consumption, such as that served in hospital cafeterias and airplanes, and that sold by food service vendors      (such as mall cookie counters, sidewalk vendors and vending machines);

»  ready-to-eat food that is not for immediate consumption but is prepared primarily on site (such as bakery, deli and candy store items);

»  food shipped in bulk, as long as it is not for sale in that form to consumers;

»  medical foods, such as those used to address the nutritional needs of patients with certain diseases;

»  plain coffee and tea, some spices, and other foods that contain no significant amounts of any nutrients.

 

For more on food labeling, see http://www.cfsan.fda.gov/label.html. 

 

 

NEW POSTINGS ON FDA.GOV

 

FDA has recently posted:

 

» an information site devoted to Avandia, the Type 2 diabetes

drug that recent studies have shown to potentially increase the

risk of heart attack and heart-related deaths

http://www.fda.gov/cder/drug/infopage/rosiglitazone/default.htm

 

» FDA & You, a free online newsletter for students, parents,

and educators containing current information on FDA-related

medical product and health topics

http://www.fda.gov/cdrh/fdaandyou/issue13.html

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