FDA News Digest
September 18,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- Dangerous E.
coli Strain Prompts FDA to
Urge Avoiding Fresh
Spinach
-- Access Expanded
to Blood Test that Screens for Lead
Poisoning
-- New Type of Drug
Approved to Prevent Invasive Fungal
Infections
-- Guidelines
Emphasize Responsibilities of Human Tissue
Industry
--
Renowned Ethicist Robert Nelson to Advise FDA on
Pediatric
Issues
»
Latest FDA Consumer Magazine Available
Online
»
Recalls/Safety
Alerts
»
Upcoming Public
Meetings
» Question of
the Week
____________________________________________
NEWS
Dangerous
E. coli Strain Prompts FDA to Urge Avoiding
Fresh Spinach
FDA is advising consumers
not to eat fresh spinach or fresh spinach-containing products following an
outbreak of illness in 19 states caused by E.
coli O157:H7, a dangerous bacterial strain. At press time, 109
people had been sickened, including 16 with kidney failure and one death.
Access Expanded
to Blood Test that Screens
for Lead Poisoning
FDA has broadened
the availability of a simple and portable system that can test for lead in
the blood in as little as three minutes. The test, which is planned for use
at 115,000 locations nationwide, will allow children and adults to be tested and
treated for lead poisoning easier and
quicker.
New Type of Drug
Approved to Prevent Invasive Fungal
Infections
FDA has approved
Noxafil, a new kind of drug to prevent invasive fungal infections caused by
certain molds and yeast-like fungi. The drug is intended for patients
who may become seriously ill and
possibly die if infected with the fungi due
to weakened immune systems following bone marrow
transplants or cancer chemotherapy,
.
Guidelines
Emphasize Responsibilities of Human Tissue
Industry
FDA has issued
guidance telling companies that manufacture human cells, tissues, and
related cellular- and tissue-based products that they must comply with federal
regulations. The action follows two recent cases of safety violations regarding
human tissue recovery.
Renowned Ethicist Robert Nelson to Advise FDA
on Pediatric
Issues
Robert M. Nelson, M.D., is joining FDA's Office of
Pediatric Therapeutics to provide advice on ethical issues related to pediatric
clinical trials and other pediatric issues. He brings to the agency a rich
background in ethics that includes lecturing and publishing widely on ethical
and regulatory issues in pediatric research and clinical
care.
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.]
____________________________________________
Latest
FDA Consumer Magazine Available Online
The latest
issue of FDA Consumer includes articles on these
topics:
» Flu shots --
Vaccination is still the best
protection.
» Cervical cancer -- New vaccine helps protect women from
life-threatening disease.
» Counterfeit drugs -- FDA is taking new steps to strengthen
protections.
» Painkillers
for dogs -- Drugs can control canine pain, but owners should watch for
side
effects.
» Shingles --
New vaccine Zostavax can reduce the risk of this painful
disorder.
» Benzene --
FDA is working with the beverage industry to keep levels of this
chemical as low as possible.
The issue is
online at http://www.fda.gov/fdac/506_toc.html.
Subscribe to the
print version of FDA Consumer:
http://www.fda.gov/fdac/orderform/fdap.html
________________________________________________________
RECALLS/SAFETY
ALERTS
Food Recalls:
Certain lots of liquid, ready-to-feed infant formula (Similac
Alimentum Advance, Similac Advance), 32 oz.
size
Reason for recall: may not contain labeled
amount of vitamin C
Certain lots of Raw Indulgence food bars, 2.2 oz.
size
Reason for recall: may contain metal
fragments
Certain lots of Kroger Stir Fry Vegetables, 14 oz.
size
Reason for recall: undeclared wheat and
egg
Safety
Alert:
Following three cases in
Georgia of botulism associated with carrot juice that may not have been properly
refrigerated, FDA is advising consumers to keep all carrot juice --
including pasteurized -- refrigerated. Inadequate refrigeration
of carrot juice can allow botulism-causing spores to multiply to a level where
they can cause
illness.
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
Sept. 21 -- Cardiovascular and Renal
Drugs Advisory
Committee
Under discussion: clinical data for
a new use of a drug to reduce blood loss following cardiopulmonary bypass
surgery
Location: Rockville,
Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder2006-4234-nm00001.htm
Sept. 25 -- Nonprescription Drugs
Advisory Committee
Under discussion: consumer behavior
studies conducted to support marketing of nonprescription drug
products
Location: Gaithersburg,
Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11774.htm
Sept. 25 --
Veterinary Medicine Advisory Committee Fall 2006
Meeting
Under
discussion: the microbial food safety of an antimicrobial drug application
currently under review for use in food-producing
animals
Location: Rockville, Md.
http://www.fda.gov/cvm/VMAC/VMACFall2006.htm
Sept. 25 -- BioShield Stakeholders
Workshop
Under discussion: the current
BioShield interagency governance
process
Location: Arlington,
Va.
http://www.hhs.gov/ophep/ophemc/bioshield/workshop.html
Sept. 26 -- Risk
Communication on Medical Devices: Sharing Perspectives
Under discussion: how the
government and device industry communicate expected and unexpected risks to
doctors, patients and the public
Location: North Bethesda, Md.
http://www.fda.gov/cdrh/meetings/092606-riskcommunication.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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