FDA News Digest for January 7, 2007

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest for January 7, 2007

FDA News Digest

January 7, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    --  Test is First for Detecting, Identifying 12 Respiratory Viruses

    --  FDA Clears Rapid Test for Drug-Resistant Staph Infections

    --  Voluven Approved to Treat Blood Volume Loss After Surgery

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Test is First for Detecting, Identifying 12 Respiratory Viruses

FDA has cleared for marketing the xTAG Respiratory Viral Panel, a test that simultaneously detects and identifies 12 specific respiratory viruses. It is the first test for the detection and differentiation of influenza A subtypes H1 and H3. Influenza A is the most severe form of flu for humans and has been the cause of major epidemics.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01770.html

 

FDA Clears Rapid Test for Drug-Resistant Staph Infections

FDA has cleared for marketing the BD GeneOhm StaphSR Assay, the first rapid blood test for the drug-resistant staph bacterium known as MRSA (methicillin-resistant Staphylococcus aureus), which can cause potentially deadly infections. Methicillin is an antibiotic used successfully to treat infections from the Staphylococcus aureus bacterium. But over the years, the staph bacterium has mutated and spawned MRSA, a strain resistant to methicillin with a higher rate of being fatal. The new test uses molecular methods to identify whether a blood sample has genetic material from the MRSA bacterium or a more common, less dangerous staph bacterium that can still be treated with methicillin.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01768.html

 

Voluven Approved to Treat Blood Volume Loss After Surgery

FDA has approved Voluven, an intravenous solution that prevents and treats a dangerous loss of blood volume, a condition that sometimes occurs during and after surgery. Significant blood losses can cause a rapid drop in the volume of red blood cells and plasma circulating through the body. This can lead to shock, which is potentially fatal. Blood volume expanders are commonly administered to quickly restore some of the lost volume so remaining red blood cells can continue to deliver needed oxygen to the body's tissues.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01765.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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SAFETY ALERTS/RECALLS

 

Safety Alerts:

 

›  FDA is reviewing new data from two studies that provide further evidence of the risks of anemia drugs known as erythropoiesis-stimulating agents, or ESAs. The studies show that patients with breast or advanced cervical cancers who received ESAs to treat anemia caused by chemotherapy died sooner or had more rapid tumor growth than similar patients who didn’t receive the anemia drug.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01769.html

 

›  FDA is warning consumers not to eat raw oysters harvested from West Karako Bay, a section of Growing Area 3 in Louisiana. These oysters, harvested from Dec. 3 through Dec. 21, may be contaminated with norovirus. Symptoms of norovirus infection include nausea, vomiting, diarrhea and stomach cramping. Affected individuals often experience low-grade fever, chills, headache, muscle aches, and a general sense of tiredness. Most people show symptoms within 48 hours of exposure to the virus, with the illness lasting one to two days. However, the illness can become serious for the very young, the elderly and people with weakened immune systems.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01767.html

 

›  FDA is advising consumers not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular, also marketed as Shangai Chaojimengnan, products. These products, which originate in China, are being marketed for the treatment of erectile dysfunction (ED) and for sexual enhancement. Although labeled as dietary supplements, these products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for erectile dysfunction. The products are considered illegal drugs because they lack FDA approval.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01766.html 

 

Food Recall:

 

›  Weis Baker's 18-count Fruit Miniatures and two-pound platters of Mini-Fruit Diamonds in four varieties (Nut Diamond, Cheese Raspberry, Apricot and Mixed assortment)

Reason for recall: walnuts not declared on label

http://www.fda.gov/oc/po/firmrecalls/weis12_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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UPCOMING PUBLIC MEETINGS

 

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

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

 

 

CONSUMER HEALTH INFORMATION

 

Each week in FDA News Digest, we spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

 

Here's what's in the spotlight this week:

 

›  Purchasing Pet Drugs Online: Buyer Beware

http://www.fda.gov/consumer/updates/petdrugsonline121407.html

› Think Before You Ink: Are Tattoos Safe?

http://www.fda.gov/consumer/features/tattoos120607.html

 

If you would like to sign up to receive all consumer updates, go to

http://www.fda.gov/consumer/consumerenews.html  

 

Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

 

 

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