FDA News
Digest
November 21,
2005
__________________________________________________
IN THIS
WEEK'S ISSUE
-- Committee Discusses Tamiflu Adverse Events in Children
-- FDA Offers
Information on Recently Approved Medical Devices
-- Recalls/Safety
Alerts
-- Recent
Speeches
-- Upcoming Public
Meetings
-- Question of the
Week
___________________________________________________
Committee
Discusses Tamiflu Adverse Events in Children
On Nov.
18, the FDA Pediatric Advisory Committee met to discuss adverse events reported
in children taking Tamiflu and seven
other flu treatment drugs. In
conjunction with the meeting, FDA has posted questions and answers that give
background on several reported cases of skin reactions, neuropsychiatric events,
and deaths in Japanese children who took Tamiflu.
--
Questions and answers about pediatric Tamiflu use: http://www.fda.gov/cder/drug/infopage/tamiflu/QA20051117.htm
-- General Tamiflu information: http://www.fda.gov/cder/drug/infopage/tamiflu/default.htm
FDA Offers
Information on Recently Approved Medical Devices
FDA's Center
for Devices and Radiological Health has published online consumer information on
three recently approved medical devices. The information, linked on the
following list, briefly describes the devices:
--
Orbasone Pain Relief System and Orthospec
Extracorporeal Shock Wave Therapy
Intended use: an alternative to
surgery that uses strong sound waves to relieve heel pain (proximal plantar
fasciitis)
Orbasone: http://www.fda.gov/cdrh/mda/docs/p040039.html
Orthospec: http://www.fda.gov/cdrh/mda/docs/p040026.html
--
Wako LBA AFP-L3
Intended use: to help determine
the risk of developing liver cancer in patients with chronic liver
disease
http://www.fda.gov/cdrh/mda/docs/k041847.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>.]
___________________________________________________
RECALLS/SAFETY
ALERTS
Recalls:
One lot of
Novartis's enteral feeding formula
Diabetisource AC; 1.5-liter size
Reason for
recall: mislabeled product
http://www.fda.gov/oc/po/firmrecalls/novartis11_05.html
200 jars
of Harry & David Black and Kalamata Olive Tapenade; 11-oz.
size
Reason for
recall: possible contamination with Clostridium botulinum
bacteria
http://www.fda.gov/oc/po/firmrecalls/harrydavid11_05.html
Min Yue
Foods' Sweet Potato Strip; 16-oz. size
Reason for
recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/starway11_05.html
Korica
International's Dried Potato; 7-oz. size
Reason for
recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/korica11_05.html
Certain
lots of horse feed made by Tennessee Farmers
Cooperative
Reason for
recall: potentially harmful levels of monensin
sodium
http://www.fda.gov/oc/po/firmrecalls/tfc11_05.html
Safety Alert:
FDA has
asked makers of long-acting bronchodilators Advair Diskus, Serevent Diskus,
and Foradil Aerolizer to add a warning to their product labeling about an
increased chance of severe asthma episodes. Though the products can decrease the
frequency of asthma episodes, the episodes that do occur may be more
severe, possibly life-threatening.
http://www.fda.gov/cder/drug/advisory/LABA.htm
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.]
___________________________________________________
RECENT
SPEECHES
Nov. 14 -- FDA Associate Commissioner Randall Lutter, Ph.D.,
spoke before the National Association of Chain Drug Stores/Healthcare
Distribution Management Association's first summit meeting on adoption of radio
frequency identification (RFID) in heath care.
Speech
text: http://www.fda.gov/oc/speeches/2005/radiofrequencyid1114.html
To view an
archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
___________________________________________________
UPCOMING PUBLIC
MEETINGS
Dec. 1 -- Microarray Quality Control
Project Meeting
Location:
Palo Alto, Calif.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-21152.htm
Dec. 2 -- Psychopharmacologic Drugs
Advisory Committee
Under
discussion: pending application for a drug to treat attention deficit
hyperactivity disorder
Location:
Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cder12544d120205.html
Dec. 7-8 --
Hearing to
obtain public input on the agency's current risk communications and outreach
strategies, which include patient information sheets, press releases, public
health advisories, and other tools.
Location:
Washington, D.C.
http://www.fda.gov/bbs/topics/answers/2005/ans01367.html
Dec. 7-8 -- Industry Exchange Workshop on FDA's Statutory and Regulatory Requirements for Clinical Trials
Location:
Cincinnati, Ohio
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18654.htm
Dec. 15 -- Joint FDA/USDA meeting to
discuss a consistent regulatory approach concerning the jurisdiction over
certain products containing meat or poultry.
Location:
Rosemont, Ill.
http://www.fda.gov/bbs/topics/news/2005/NEW01255.html
For a list
of FDA meetings, seminars, and other public events, go
to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________
QUESTION
OF THE WEEK
What are "phakic lenses"?
Phakic intraocular lenses, or phakic lenses, are lenses made
of plastic or silicone that are implanted into the eye permanently to reduce a
person's need for glasses or contact lenses. Phakic refers to the fact that the
lens is implanted into the eye without removing the eye's natural lens.
During phakic lens implantation surgery, a small incision is made in
the front of the eye. The phakic lens is inserted through the incision and
placed just in front of or just behind the iris.
Phakic lenses are used to correct refractive errors, or errors in the
eye's focusing power. Currently all approved phakic lenses are for correction of
nearsightedness (myopia).
For more
on phakic lenses, see http://www.fda.gov/cdrh/phakic/.
__________________________________________________
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