FDA News Digest for January 3, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

Title: Message

FDA News Digest

January 3, 2006

________________________________________________________

 

IN THIS WEEK'S ISSUE

 

»  News

    --  Tamiflu Approved to Prevent Flu in Children

    --  New Treatment for Advanced Kidney Cancer Approved

    --  Food Labels Now Required to Include Plain-Language Allergen Listing

    --  Barley Products Allowed to Claim Reduced Heart Disease Risk

    --  FDA Proposes Significantly Lower Lead Levels for Candy

    --  Revlimid Approved to Treat Myelodysplastic Syndrome

    --  Generic Version of Drug Tentatively OK'd for AIDS in Children

    --  New Web Site Launched to Commemorate FDA's Centennial

    --  FDA Official to Team with AHRQ to Study Health Outcomes of Drugs

    --  Slikker Named Acting Director of FDA Toxicological Research Center

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

________________________________________________________

 

Tamiflu Approved to Prevent Flu in Children

 

FDA has OK'd another use for the oral antiviral drug Tamiflu by approving it for prevention of seasonal flu in children age 12 and under. FDA previously had approved Tamiflu for flu prevention and treatment in patients 13 years and older and for flu treatment in pediatric patients older than one year. The agency emphasizes that taking Tamiflu is not a substitute for the annual flu vaccine.

http://www.fda.gov/bbs/topics/news/2005/NEW01285.html 

 

New Treatment for Advanced Kidney Cancer Approved

 

FDA has approved Nexavar (sorafenib tosylate) to treat adults with advanced renal cell carcinoma, the most common type of kidney cancer. Two studies showed that the drug roughly doubled the median time before tumor progression or death -- to 167 days versus 84 days in untreated patients. Occurring most often in people between 50 and 70, and affecting men almost twice as often as women, kidney cancer kills about 12,000 people yearly.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01282.html

 

Food Labels Now Required to Include Plain-Language Allergen Listing

 

FDA is now requiring manufacturers to state in plain language on food labels whether their products contain any of eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, or soybeans. The agency says the new labeling should be especially helpful to children with allergies who must learn what foods to avoid. The labeling requirement, which became effective Jan. 1, is the result of a 2004 allergen labeling law.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01281.html

 

Barley Products Allowed to Claim Reduced Heart Disease Risk

 

Whole-grain barley and barley-containing products are now allowed to carry a claim that they may reduce the risk of coronary heart disease. FDA based its decision to allow the claim on scientific evidence showing that barley can contribute to lowering serum cholesterol levels.

http://www.fda.gov/bbs/topics/news/2005/NEW01287.html

 

FDA Proposes Significantly Lower Lead Levels for Candy

 

Prompted by discovery of certain types of Mexican candy that showed elevated lead levels, FDA is proposing to reduce the maximum levels of lead currently allowed in candy -- to 0.1 parts per million (ppm), a significant drop from the present threshold of 0.5 ppm. FDA says the action will further lower exposure of children to small traces of lead present in some candies.

http://www.fda.gov/bbs/topics/NEWS/2005/NEW01284.html

 

Revlimid Approved to Treat Myelodysplastic Syndrome

 

FDA has approved Revlimid (lenalidomide) to treat patients with a type of myelodysplastic syndrome (MDS) called deletion 5q cytogenetic abnormality. MDS is a collection of disorders in which bone marrow does not function normally and the body does not make enough normal blood cells. About 7,000 to 12,000 new cases of MDS are diagnosed yearly in the United States.

http://www.fda.gov/bbs/topics/news/2005/NEW01289.html

 

Generic Version of Drug Tentatively OK'd for AIDS in Children

 

FDA has tentatively approved Stavudine, a generic version of the HIV/AIDS drug Zerit. Stavudine is intended to treat HIV-infected children from birth through adolescence. The agency's tentative approval means that, although existing patents or exclusivity agreements prevent U.S. marketing of the product, the drug meets FDA's standards for quality, safety, and effectiveness. The product will now be available for use outside the United States under the President's Emergency Plan for AIDS Relief.

http://www.fda.gov/bbs/topics/news/2005/NEW01283.html

 

New Web Site Launched to Commemorate FDA's Centennial

 

In honor of FDA's 100th year, the agency has created a Web site that gives a quick study on FDA history and offers some fun features. Read all about the agency's humble beginnings in 1906 as the Bureau of Chemistry helmed by crusading public health proponent Harvey Wiley. Check out the many milestones FDA has placed in the history books over the last century. And if you're up to the challenge, take a quiz to check your FDA I.Q.

http://www.fda.gov/centennial/

 

FDA Official to Team with AHRQ to Study Health Outcomes of Drugs

 

Anne Trontell, deputy director of the FDA Office of Drug Safety, will spend a year, beginning in mid-January, as a senior adviser in pharmaceutical outcomes in the Agency for Healthcare Research and Quality. Her duties will include participating in risk communication research and outreach.

http://www.fda.gov/bbs/topics/news/2005/NEW01286.html

 

Slikker Named Acting Director of FDA Toxicological Research Center

 

FDA has appointed William Slikker Jr., Ph.D., acting director of the agency's National Center for Toxicological Research. The center studies the biological effects of toxic chemical, biological, and physical agents and develops methods to gauge the exposure, susceptibility, and risk of these agents to humans. Slikker is replacing Daniel A. Casciano, Ph.D., who directed the center for more than six years and is leaving for a job in the private sector.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01291.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

 

Recalls:

 

Certain lots of Diamond Pet Food products formulated with corn

    Reason for recall: possible aflatoxin contamination

-- Recall information: http://www.fda.gov/oc/po/firmrecalls/diamond12_05.html

-- FDA consumer alert: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01290.html

 

Three types of JHC brand cooked, seasoned anchovies

    Reason for recall: possible Salmonella contamination

http://www.fda.gov/oc/po/firmrecalls/ustrading12_05.html

 

Safety Alerts:

 

FDA has updated information about malfunctions of Guidant Corp.'s Prizm 2 and Contac Renewal implantable cardioverter defibrillator (ICD) devices: As of Dec. 21, 35 clinical failures of the devices, including five patient deaths, had been reported. FDA announced a recall of the devices last July and offered recommendations on clinical management of patients with these devices.

-- Updated information: http://www.fda.gov/cdrh/safety/122805-guidant.html

-- Original notice (with patient recommendations): http://www.fda.gov/cdrh/safety/071405-guidant.html  

 

Due to concerns about levels of a naturally occurring toxin called hypoglycin that was found in cans of Ashman's Ackees in Brine, FDA is advising consumers not to eat this Jamaican tropical fruit product. The agency says 31 cases of the 19-oz. cans are being recalled.

http://www.fda.gov/bbs/topics/news/2005/NEW01288.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. 20 -- Regulatory Process for Pediatric Mechanical Circulatory Support

    Under discussion: regulation and approval of circulatory support devices used for temporary support in pediatric patients

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-24271.htm

 

Jan. 23 -- Joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee

    Under discussion: pending application for over-the-counter use of the prescription weight-loss drug Orlistat 

    Location: Bethesda, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012306.html

 

Jan. 24 -- Joint meeting of the Nonprescription Drugs Advisory Committee and the Pulmonary-Allergy Drugs Advisory Committee

    Under discussion: the continuing need to designate over-the-counter epinephrine metered-dose inhalers as an essential use of ozone-depleting substances

    Location: Bethesda, Md.

http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html

 

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

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

_________________________________________________________

QUESTION OF THE WEEK

 

How do biological products (biologics) differ from conventional drugs?

In contrast to most drugs that are chemically synthesized and their structure is known, most biologics are complex mixtures that are not easily identified or characterized. Biological products include vaccines, human tissue, blood, and blood products. Biologics, including those manufactured by biotechnology, tend to be more heat sensitive and susceptible to microbial contamination than drugs. Therefore, it is necessary to take steps to ensure a germ-free manufacturing environment when producing biological products.

Biological products often represent the cutting-edge of biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have no other treatments available.

For more on biologics, see http://www.fda.gov/cber/index.html.                                                               ________________________________________________________

Thanks for subscribing to FDA News Digest. Our next posting will be January 9.

 

To subscribe to or unsubscribe from this list, go to

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