FDA News Digest for November 20, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

November 20, 2006

________________________________________________________

 

IN THIS WEEK'S ISSUE

»  News

    -- Silicone Gel Breast Implants From Two Manufacturers Approved

    -- FDA Broadens Approval of Breast Cancer Treatment Herceptin

    -- New Tools Developed to Help Consumers Use Nutrition Label

»  Latest FDA Consumer Magazine Available Online 

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

____________________________________________

 

NEWS

 

Silicone Gel Breast Implants From Two Manufacturers Approved

FDA has approved the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women aged 22 and older. FDA will monitor the products by requiring each company to conduct a study that follows about 40,000 women for 10 years.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01512.html 

 

FDA Broadens Approval of Breast Cancer Treatment Herceptin

FDA has approved an expanded use of the drug Herceptin for treatment of breast cancer when the protein HER2 is present. The new approval is for women with cancer in the breast or lymph nodes that has been surgically removed. Herceptin was approved initially in 1998 to treat breast cancer that had spread.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01511.html

 

New Tools Developed to Help Consumers Use Nutrition Label

As part of an agency effort to help consumers choose nutritious foods and achieve a healthy weight, FDA has created two tools that aim to explain how to use the Nutrition Facts label. One tool, "Make Your Calories Count," is an online interactive program that takes viewers through a series of food label exercises. The second tool, "Nutrition Facts Label," is a brochure that can help consumers shop and plan healthy meals.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01508.html

-- "Make Your Calories Count": http://www.cfsan.fda.gov/labelman  

-- "Nutrition Facts Label": http://www.cfsan.fda.gov/~acrobat/nutfacts.pdf

 

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.]

____________________________________________

Latest FDA Consumer Magazine Available Online

 

The latest issue of FDA Consumer includes articles on these topics:

 

»  Health fraud -- Protecting consumers from bogus devices and other products.

»  Buying pet drugs online -- FDA says "Buyer beware" to avoid unscrupulous Web pharmacies.

»  Lead screening -- Improved test can quickly determine lead poisoning in children, adults.

»  HIV treatment -- New 3-in-1 tablet simplifies drug regimen for adults.

»  Bioterrorism -- Novel test can detect fake bioterror substances. 

»  Clinical trials -- FDA is strengthening patient protections.

 

The issue is online at http://www.fda.gov/fdac/606_toc.html.  

 

Subscribe to the print version of FDA Consumer:  http://www.fda.gov/fdac/orderform/fdap.html

_________________________________________________ 

RECALLS/SAFETY ALERTS

Cosmetic Recall:

 

Various lots of wet wipes under the Equate and Member's Mark brands

    Reason for recall: potential bacterial contamination

http://www.fda.gov/oc/po/firmrecalls/rockline11_06.html

 

Food Recalls:

 

Cooked winter squash under the Birds Eye label and other store brands

    Reason for recall: potential ammonia contamination

http://www.fda.gov/oc/po/firmrecalls/birdseye11_06.html

 

Washington Seafood Breader, 2 lb. size

    Reason for recall: undeclared milk

http://www.fda.gov/oc/po/firmrecalls/wilkins11_06.html

 

Sundia brand cantaloupe (504 cartons, distributed in several states between Oct. 30 and Nov. 6)

    Reason for recall: potential Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/timco11_06.html

 

Llano and Nature's Partner brand cantaloupe

    Reason for recall: potential Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/riovista11_06.html

 

Wegmans Italian Classics Lemon and Caper Sauce, 11 oz. jars (with "use-by" date of 11/5/07)

    Reason for recall: may contain pieces of glass

http://www.fda.gov/oc/po/firmrecalls/wegmans11_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.]

_____________________________________________

 

UPCOMING PUBLIC MEETINGS

Nov. 29 -- Arthritis Advisory Committee

    Under discussion: pending application for drug to treat juvenile rheumatoid arthritis

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8787.htm

 

Dec. 7-8 -- Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: issues related to blood clotting in coronary drug-eluting stents

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-17519.htm

 

Dec. 18 -- Public hearing to solicit comments on electronic submission of premarket material and other regulatory information

    Location: Rockville, Md.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01510.html

 

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

 

I've heard that antibiotics shouldn't be used to treat viral illnesses like colds and the flu. What should they be used for?

 

Antibiotics are used to treat illnesses caused by bacteria. Examples include strep throat, tuberculosis and many types of pneumonia. Taking antibiotics when they aren't needed contributes to the serious problem of antibiotic resistance. This is when bacteria have become resistant and cannot be killed by antibiotics. If the antibiotic misuse continues, some recurring infections ultimately may have to be treated with different and stronger antibiotics, leading to the possibility that eventually no antibiotic will be effective in killing the bacteria.

 

There are many over-the-counter products available to treat the symptoms of viral infections. These include cough suppressants to help control coughing and decongestants to help relieve a stuffy nose. Read the label and ask your pharmacist or doctor if you have any questions about which will work best for you.

 

To learn more about antibiotic resistance, see http://www.fda.gov/oc/opacom/hottopics/anti_resist.html.

__________________________________________________

Thanks for subscribing to FDA News Digest. Our next issue will be sent November 27.

 

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

 

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