FDA News Digest for April 9, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

April 9, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Web Page Tracks Studies of Medical Devices Conducted After Approval

    -- HepaGam B OK'd to Prevent Hepatitis B Reinfection After Liver Transplants

    -- Companies Told to Stop Marketing Suppositories with Trimethobenzamide

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

Web Page Tracks Studies of Medical Devices Conducted After Approval

FDA has unveiled a new Web page designed to track the status of patient studies of recently approved medical devices conducted after approval. Because some potential risks don't always emerge during clinical trials of devices, FDA sometimes orders post-approval studies after a product is used more widely or for a longer period. The new page includes information on all post-approval studies the agency has ordered since Jan. 1, 2005.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01603.html

-- New Web page: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm

 

HepaGam B OK'd to Prevent Hepatitis B Reinfection After Liver Transplants

FDA has approved HepaGam B, the first product of its kind for the prevention of hepatitis B reinfection in certain liver transplant patients. Patients previously exposed to the hepatitis B virus are at an increased risk of reinfection because they have weakened immune systems. HepaGam B works by providing an immediate immune response to the hepatitis B virus.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01602.html

 

Companies Told to Stop Marketing Suppositories with Trimethobenzamide

FDA has told companies to stop making and distributing suppository drugs containing trimethobenzamide hydrochloride. These drugs are used to treat nausea and vomiting, but in suppository form, they lack evidence of effectiveness.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01601.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 Product Recalls:

 

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

 

FDA also warns consumers to avoid American Bullie A.B. Bull Pizzle Puppy Chews and Dog Chews due to possible Salmonella contamination.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01600.html

 

Safety Alert:

 

FDA is reminding consumers that contact with baby turtles can pose a serious health risk to infants, small children, and adults with impaired immune systems. The outer skin and shell surface of the turtles can harbor Salmonella bacteria, which can cause severe illness or death. A four-week-old infant in Florida recently died of infection traced to Salmonella also found on a pet turtle.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01604.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

 

April 10 -- National Antimicrobial Resistance Monitoring System (NARMS) Program Subcommittee of the FDA Science Advisory Board

    Under discussion: the NARMS program

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-5153.htm

 

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

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

 

 

QUESTION OF THE WEEK

 

What is sleep apnea and how is it treated?

 

Snoring loud and often, together with too much daytime sleepiness, may be signs of sleep apnea, a very common sleep disorder that can also be dangerous. The most common type of sleep apnea happens when your breathing stops during sleep. It can stop for about 10 seconds to as long as a minute. You wake up trying to breathe. This stop-and-start cycle of waking to breathe can repeat hundreds of times a night. The danger is that one time you may not wake up to breathe. If this happens, you can die.

 

You are likely to feel sleepy during the day if you have this problem. People with sleep apnea tend to be overweight. It is more common among men than women.

 

Sleep apnea is usually treated this way:

 

» The most common treatment is a device called continuous positive airway pressure (CPAP) that pushes air through the airway.

» Avoid beer, wine, liquor, tobacco, and sleeping pills.

» Your doctor may suggest that you lose weight.

» In some cases, you may need surgery to make the airway bigger.

 

For more information on sleep disorders, see http://www.fda.gov/womens/getthefacts/sleep.html. 

 

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