FDA News Digest for October 30, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

October 30, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- New Drug Approved to Treat Chronic Hepatitis B in Adults

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

New Drug Approved to Treat Chronic Hepatitis B in Adults

FDA has approved Tyzeka to treat adults with chronic hepatitis B. Tyzeka is a new type of drug that contains an active substance never before approved for marketing in the United States. Hepatitis B is a serious viral infection that attacks the liver and can cause scarring (cirrhosis) and eventually liver cancer, liver failure, and death. About 70,000 Americans become infected with hepatitis B yearly.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01498.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

Drug Recall:

 

All products repackaged by Heartland Repack Services with lot numbers that begin with "K"

    Reason for recall: potential for mislabeling and packaging mix-up

http://www.fda.gov/medwatch/safety/2006/safety06.htm#heartland   

 

Food Recall:

 

Various salad and slaw products distributed by Ballard's Farm Sausage Inc.  

    Reason for recall: potential Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/ballard210_06.html

 

Safety Alert:

 

FDA is warning consumers about the serious risks involved with using decorative contact lenses without oversight from an eye care professional. These lenses -- sometimes used for a costume effect at Halloween -- are marketed at flea markets, convenience stores, beach shops, and on the Internet. FDA has received reports of corneal ulcers in wearers of decorative lenses. Corneal ulcers, at the extreme, can cause blindness and eye loss.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01499.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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UPCOMING PUBLIC MEETINGS

Oct. 31 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for approval of a device to treat depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/06-8114.htm

 

Nov. 6-7 -- "A Critical Path Approach to Rapid Diagnostics Development and Infectious Disease Treatment"

    Under discussion: shortening the critical path in new product development

    Location: Washington, D.C.

http://www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=11361&eventType=Meeting

 

Nov. 15-16 -- Detroit District Workshop on FDA Clinical Trial Statuary and Regulatory Requirements

    Under discussion: FDA regulation of clinical research conduct, informed consent requirements, other topics

    Location: Indianapolis

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13114.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 arthritis, and why do people get it?

Arthritis is a disease of the joints. Painful, stiff joints are the most common signs of arthritis. Other signs are swelling, warmth, and redness in the joints. People with arthritis often have trouble moving the joints normally.

 

Arthritis is a problem for many adults 65 and older. About 42 million Americans have some form of arthritis. It can affect people of all ages and races.

 

People get arthritis because:

-- They put stress on joints over time.

-- They are overweight.

-- It runs in their family.

-- They are women. Women are affected two to three times more often than men.

 

For more on arthritis, see http://www.fda.gov/womens/getthefacts/arthritis.html.

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