FDA News Digest for January 3, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

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Note to subscribers:

This week's issue of FDA News Digest was delayed two days

due to the New Year's Day holiday on Jan. 1 and the closing

of federal agencies on Jan. 2 to honor former President Ford.

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FDA News Digest

January 3, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- FDA Drafts Three Documents on Animal Clone Safety

    -- Strengthened Safety Labeling Proposed for OTC Pain Relievers

    -- New Type of Drug Approved as Treatment for  Schizophrenia

    -- FDA OKs Generic Versions of Nausea-Preventing Drug Zofran

    -- Novel Device Can Prevent or Reduce Brain Damage in Infants

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

FDA Drafts Three Documents on Animal Clone Safety

FDA has drafted a risk assessment, a proposed risk management plan, and industry guidance, all related to the safety of cloned animals. The agency is seeking public comments on the documents, which are available online. Comments can be submitted electronically.

-- Press release: http://www.fda.gov/bbs/topics/NEWS/2006/NEW01541.html 

-- Animal cloning documents: http://www.fda.gov/cvm/CloneRiskAssessment.htm

 

Strengthened Safety Labeling Proposed for OTC Pain Relievers

FDA is proposing labeling changes for a variety of over-the-counter pain relievers that include safety information on the potential for stomach bleeding and liver damage, as well as when to contact a doctor. Some manufacturers have already voluntarily added the safety information to their products.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01533.html

 

New Type of Drug Approved as Treatment for  Schizophrenia

FDA has approved the new drug Invega to treat schizophrenia, a disabling mental disorder affecting more than 2 million Americans. Invega is a "new molecular entity," meaning it contains an active ingredient never before approved in the United States. FDA says the drug's approval "adds to the treatment options for patients with this condition."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01534.html

 

FDA OKs Generic Versions of Nausea-Preventing Drug Zofran

FDA has approved generic versions of Zofran tablets, orally disintegrating tablets, and oral solution, which are used to prevent nausea and vomiting associated with surgery, radiation therapy, and chemotherapy. Using generic drugs can save consumers considerable money because they are frequently a fraction of the cost of equivalent brand-name drugs.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01539.html

 

Novel Device Can Prevent or Reduce Brain Damage in Infants

FDA has approved the Olympic Cool-Cap system, a new type of medical device to treat babies born with moderate-to-severe hypoxic-ischemic encephalopathy, a potentially fatal brain injury caused by low oxygen levels. The system can prevent or reduce damage by keeping the head cool while the body is maintained at a slightly below-normal level.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01537.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

Safety Alert:

 

FDA is alerting health professionals and patients that the agency has received reports of two patients taking the drug Rituxan who developed progressive multifocal leukoencephalopathy, a fatal viral infection of the central nervous system. The patients were being treated "off-label" for systemic lupus erythematosus, an unapproved, but permissible, use for Rituxan.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01532.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

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

 

Jan. 23-24 -- Reproductive Health Drugs Advisory Committee

    Under discussion: oral and non-oral hormonal contraceptives

    Location: Rockville, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-21949.htm

 

Jan. 26 -- Neurological Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a medical device that treats depression

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-20552.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 steps can I take to ensure safe consumption of eggs?

Though the holidays are over, and the last of the eggnog is probably gone, egg safety should be practiced year-round. Eggs may contain Salmonella bacteria, which can cause a potentially serious intestinal infection. The best way to prevent egg-related illness is by knowing how to buy, store, handle, and cook eggs -- and the foods that contain them -- safely. This means keeping eggs refrigerated, cooking them until the yolk is firm, and thoroughly cooking foods containing eggs.

 

For more on egg safety, see http://www.cfsan.fda.gov/~dms/fs-eggs.html.

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