FDA News Digest for February 4, 2008

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

Title: FDA News Digest for February 4, 2008

FDA News Digest

February 4, 2008

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IN THIS WEEK'S ISSUE

 

»  News

    -- Food, Medical Product Safety Among Key FY 'O9 FDA Budget Requests

    -- Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use

    -- FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries   

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Food, Medical Product Safety Among Key FY 'O9 FDA Budget Requests

FDA is requesting nearly $2.4 billion as part of the president's fiscal year (FY) 2009 budget—a 5.7 percent increase over the current fiscal year budget. The budget proposal includes strategic increases to strengthen food protection, modernize drug safety, speed approval of generic drugs, and improve the safety and review of medical devices. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01789.html

 

Doubled Risk of Suicidal Thoughts, Behaviors Seen With Antiepileptic Use

FDA has alerted health care professionals about an increased risk of suicidal thoughts and behaviors (suicidality) in patients who take drugs called antiepileptics to treat epilepsy, bipolar disorder, migraine headaches, and other conditions. An FDA analysis of suicidality reports from placebo-controlled studies of 11 antiepileptic drugs shows that patients taking these drugs have about twice the risk of suicidal thoughts and behaviors (0.43 percent), compared with patients receiving a placebo (0.22 percent).

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01786.html

 

FDA Approves New Drug-Eluting Stent for Opening Clogged Heart Arteries

FDA has approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries. The device  

is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to a narrowed section of a coronary artery through a long, thin catheter. When the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01787.html

 

To view an archive of recent 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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CONGRESSIONAL TESTIMONY

 

Jan. 29 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations.

    Subject: "Science at FDA"

http://www.fda.gov/ola/2008/science012908.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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SAFETY ALERTS/RECALLS

 

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

 

Feb. 5 -- Cellular, Tissue and Gene Therapies Advisory Committee

    Under discussion: updates of ongoing research programs

    Location: Bethesda, Md., and by teleconference

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-25124.htm

 

Feb. 6 -- Psychopharmacologic Drugs Advisory Committee

    Under discussion: pending application for a new schizophrenia treatment

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24627.htm

 

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:

 

› Devices That Keep the Heart Beating

http://www.fda.gov/consumer/features/cardiacdevices013008.html

› Pet Turtles: Cute but Contaminated with Salmonella

http://www.fda.gov/consumer/updates/turtles012508.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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Our next issue will be sent February 11.

 

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