FDA News -- FDA News Digest for February 4, 2008

FDA News Digest

February 4, 2008

_____________________________________

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

__________________________________________

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.]

_____________________________________________

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

_____________________________________________

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.]

__________________________________________________________________

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.

Thanks for subscribing to FDA News Digest.

Our next issue will be sent February 11.

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420