FDA News Digest
October 10,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- 3 Deaths Confirmed in Spinach Outbreak; Search Warrants Issued
-- New Drug Approved to Treat Irritability Associated With
Autism
-- Novel Test Helps Diagnose the Main Virus That
Causes
AIDS
-- Additional Flu Vaccine Approved to
Immunize Patients Over
18
-- Updated File System Aims to Improve Generic Drug Review
Process
--
FDA Approves Drug Treatment for Rare Type of Skin
Cancer
-- FDA Seeks to Stop Distribution of Unapproved Joint
Replacements
-- Dentistry Products Firm Barred from Making,
Distributing Dental
Drugs
-- Latest 'Patient Safety News' Video
Available Free
Online
» Recalls/Safety
Alerts
» Congressional
Testimony
»
Upcoming Public
Meetings
»
Question of the
Week
____________________________________________
NEWS
3 Deaths Confirmed in Spinach Outbreak; Search Warrants Issued
An FDA statement
confirms that as of Oct. 6, spinach contaminated with the dangerous bacterial
strain E. coli O157:H7 had caused three U.S. deaths, 31 cases
of kidney failure, and 102 hospitalizations. On Oct. 4, a U.S. district
court issued search warrants on two California companies in connection with
the spinach
outbreak.
New Drug Approved to Treat Irritability
Associated With
Autism
FDA has approved Risperdal to treat irritability in
autistic children and adolescents. It is the first drug to be approved for
autism-related behaviors in children, which include aggression, deliberate
self-injury, and temper tantrums. Risperdal is already approved for treatment of
schizophrenia and extreme mood swings in
adults.
Novel Test Helps Diagnose the Main Virus
That Causes
AIDS
FDA has approved the APTIMA HIV-1 RNA Qualitative
Assay, the first test for detection of genetic material in HIV. The
APTIMA test can be used as an alternative to the Western blot, an existing
test used to confirm positive results in HIV-screening
tests.
Additional Flu Vaccine Approved to
Immunize Patients Over
18
FDA has approved FluLaval, a vaccine for immunizing
people 18 years and older against flu strains likely to show up in the Northern
Hemisphere in 2006-2007. The approval now brings to five the number of
FDA-licensed vaccines for the upcoming flu
season.
Updated File System Aims to Improve Generic Drug
Review
Process
FDA has adopted a new
system for electronic review and archiving of applications to market
generic drugs. The Division File System is expected to improve the efficiency of
the generic review process by, among other things, allowing full access to all
available information on approved
drugs.
FDA Approves Drug Treatment for Rare Type of
Skin
Cancer
FDA has approved Zolinza to treat cutaneous T-cell
lymphoma, a rare skin cancer diagnosed in about three in every one million
people yearly in the United States. Zolinza was approved under FDA's orphan
drugs program, which provides financial incentives to companies that develop
treatments for diseases that affect fewer than 200,000 U.S. patients per
year.
FDA Seeks to Stop Distribution of
Unapproved Joint
Replacements
Following earlier FDA warnings to Florida-based Endotec
International that the company was illegally distributing unapproved total joint
replacement devices, the agency is seeking a court-ordered injunction to stop
device distribution. The company, FDA says, does not have an approved
application to market the devices, nor have the devices undergone an approved
clinical
study.
Dentistry Products Firm Barred from
Making, Distributing Dental
Drugs
According to the provisions of a consent decree
announced Oct. 6, Canfield Co. Inc. may not make or distribute unapproved drugs
and products that fail to meet federal good manufacturing practices. The
company's products were promoted to treat dental conditions. FDA
determined that despite repeated warnings Canfield had failed to correct
manufacturing
violations.
Latest 'Patient Safety News' Video
Available Free
Online
FDA has posted the latest
edition of "Patient Safety News," a free Web-based video news program aimed
primarily at health professionals. The program features information on new
drugs, biologics, and medical devices, as well as FDA safety notifications
and product recalls.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
To
view an archive of past FDA news releases, go to
Food Recalls:
Foxy brand green leaf
lettuce
Reason for
recall: E. coli bacteria found in irrigation water
(Note: FDA emphasizes that no determination has been made
whether the bacteria found is a dangerous strain, and the agency commends
The Nunes Company for initiating the precautionary
recall.)
Limited number of Tuscan Sun
Turkey sandwiches
Reason for recall: possible
Listeria monocytogenes
contamination
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.]
_____________________________________________
CONGRESSIONAL
TESTIMONY
Sept. 13 -- FDA Center for Devices and Radiological Health
Director Daniel Schultz,
M.D., appeared before the House Committee on Government
Reform.
Subject: reuse of single-use devices
http://www.fda.gov/ola/2006/suds0926.html
To view an archive of
past testimony by FDA officials, go to
http://www.fda.gov/ola/listing.html.
____________________________________________________
UPCOMING PUBLIC MEETINGS
Oct. 18-19 -- Clinical Pharmacology
Subcommittee of the Advisory Committee for Pharmaceutical
Science
Subject: possible tamoxifen labeling
changes; evaluation of transporter-based drug
interactions
Location: Rockville,
Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-14296.htm
Oct. 19-20 -- Antiviral Drugs Advisory
Committee
Subject: clinical trials for
hepatitis C treatments
Location: Silver Spring,
Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-12890.htm
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 is cardiovascular
disease?
Cardiovascular disease (CVD)
is not one single disease or condition. It is a group of different disorders
that affect your heart and blood vessels. Some types of CVD occur from birth,
and others are developed over a lifetime.
To learn more about specific
cardiovascular conditions and diseases go to the following links:
-- Angina (chest pain): http://www.fda.gov/hearthealth/conditions/angina.html
-- Atherosclerosis (hardening of
the arteries): http://www.fda.gov/hearthealth/conditions/atherosclerosis.html
-- Congestive heart failure: http://www.fda.gov/hearthealth/conditions/congestiveheartfailure.html
-- Coronary artery disease: http://www.fda.gov/hearthealth/conditions/coronaryarterydisease.html
-- Heart attack: http://www.fda.gov/hearthealth/conditions/heartattack.html
__________________________________________________
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