FDA News Digest
October 2,
2006
________________________________________________________
IN THIS WEEK'S
ISSUE
» News
-- Origin of Contaminated
Spinach Pinpointed in Current Outbreak
-- New Treatment Approved for Colorectal Cancer That
Has
Spread
-- FDA Approves Treatment for Exposure to Certain Nerve
Agents
-- New Data on Blood-Loss Drug Trasylol Prompt FDA
Recommendations
-- Guidance Aimed at Promoting Development of New Viral
Vaccines
-- FDA Issues Manufacturing Guidance for Pharmaceutical
Industry
» Recalls/Safety
Alerts
»
Upcoming Public
Meetings
»
Question of the
Week
____________________________________________
NEWS
Origin of Contaminated
Spinach Pinpointed in Current Outbreak
FDA has determined that
all spinach in the current outbreak of infection with the
dangerous bacterial strain E. coli O157:H7 has traced back to Natural Selection Foods LLC, of San
Juan Bautista, Calif. One death has
occurred in the outbreak, along with 29 instances of kidney failure and 97 hospitalizations. FDA anticipates that producers of spinach and other
leafy greens will now develop a plan to minimize the risk of another
outbreak.
New Treatment Approved for Colorectal
Cancer That Has
Spread
FDA has approved Vectibix to treat patients with
colorectal cancer that has spread to other parts of the body following standard
chemotherapy. The drug has shown effectiveness in slowing tumor growth and, in
some cases, reducing tumor size. Colorectal cancer is the third most common
cancer in the United States and the third leading cause of cancer deaths, FDA
says.
FDA Approves Treatment for Exposure to Certain
Nerve Agents
FDA has approved the injected drug Duodote for use by
trained medical personnel to treat civilians following exposure to
life-threatening nerve agents such as sarin. FDA says the approval clears the
way for stockpiling the drug as an emergency treatment. FDA approved a
similar product four years ago for use only by the
military.
New Data on Blood-Loss Drug Trasylol
Prompt FDA
Recommendations
Following release of research linking the
blood-loss drug Trasylol to an increased risk of heart attack, stroke, or kidney
dysfunction or failure, FDA is advising healthcare professionals to
take certain precautions. These include monitoring patients
for possible signs of toxicity and limiting use of the drug to
situations where clinical benefit clearly outweighs potential
risks.
Guidance Aimed at Promoting Development of New
Viral Vaccines
FDA has released new guidance designed to aid
manufacturers in developing safe and effective cell-based viral vaccines,
including those to address emerging and pandemic threats. The guidance updates
agency recommendations published in
1993.
FDA Issues Manufacturing Guidance for
Pharmaceutical
Industry
FDA has issued a final guidance document on quality
systems, which are formal practices to help ensure the quality of human and
animal drugs during manufacturing. The document makes a case for incorporating
modern quality principles into manufacturing processes, which should help foster
technical advancements.
To
view an archive of past FDA news releases, go to
Food Recall:
Certain lots of various brands of nacho-flavored
tortilla chips distributed by Snack Alliance
Inc.
Reason for recall: undeclared soy
Safety
Alert:
In response to a fourth case of botulism
associated with carrot juice, FDA is advising consumers not to drink
containers of Bolthouse Farms carrot juice with "best if used
by" dates of Nov. 11, 2006, or earlier. FDA is investigating inadequate
refrigeration and other possible
links as possible causes of the
tainted
juice.
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
Oct. 4 -- Joint meeting of the Endocrinologic and
Metabolic Drugs Advisory Committee and the Advisory Committee for Pharmaceutical
Science
Under discussion: the quality of currently marketed
levothyroxine sodium drug products
Location: Gaithersburg,
Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-11471.htm
Oct. 5-6 -- Advisory Committee for Pharmaceutical
Science
Under discussion: International Conference on Harmonization
Quality; FDA Critical Path Initiative
Location: Rockville, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/E6-13506.htm
Oct. 10 --
FDA-Regulated Products Containing Nanotechnology
Materials
Under
discussion: new nanotechnology-based materials in areas such as foods,
cosmetics, animal feeds, and medical devices
Location:
Bethesda, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/06-6867.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
How can you determine if fish is
fresh?
Here are some
tips:
» The fish's eyes should be clear
and bulge a little. Only a few fish, such as walleye, have naturally cloudy
eyes.
» Whole fish and fillets should have
firm, shiny flesh. Dull flesh may mean the fish is old. Fresh whole fish also
should have bright red gills.
» If the flesh doesn't spring
back when pressed, the fish isn't fresh.
» There should be no darkening
around the edges of the fish or brown or yellowish discoloration.
» The fish should smell fresh and
mild, not fishy or ammonia-like.
For more information on fish and
other seafood, see http://www.cfsan.fda.gov/seafood1.html.
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