FDA News Digest
July 18,
2005
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IN THIS WEEK'S
ISSUE
-- Potential Lethal Effects
Prompt Withdrawal of Pain Drug Palladone
-- FDA Issues Advisory on
Fentanyl Patches Following Death Reports
-- First Generic Version of
Retrovir Tentatively Approved for AIDS Relief
-- Latest FDA Consumer Magazine Available Online
-- Recalls/Safety Alert
-- Public Meetings
-- Question of the
Week
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Potential Lethal Effects Prompt
Withdrawal of Pain Drug Palladone
At FDA's request, Purdue Pharma L.P.
has agreed to withdraw its pain drug Palladone (hydromorphone) from the
market after the agency determined that potentially fatal side effects
could occur if patients take the drug with alcohol.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01205.html
-- More information: http://www.fda.gov/cder/drug/infopage/palladone/default.htm
FDA Issues Advisory on Fentanyl
Patches Following Death Reports
In response to reports of deaths
among patients using fentanyl skin patches (Duragesic) for pain management,
FDA has issued a public health advisory urging patients using the product to
follow directions exactly to prevent an overdose of what it calls a
"potent narcotic." The advisory is intended to inform patients and health care
professionals who may not be fully aware of the drug's potential
dangers.
-- FDA statement:
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01206.html
-- More information: http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm
First Generic Version of Retrovir
Tentatively Approved for AIDS Relief
FDA has tentatively approved the
first generic version of the HIV/AIDS drug Retrovir. The product will
now be available for use outside the United States under the President's
Emergency Plan for AIDS Relief.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01204.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.]
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Latest FDA Consumer Magazine Available
Online
The July-August 2005 issue of
FDA Consumer has articles on
the following topics:
-- Rabies -- Learn how to prevent this
deadly disease in your pets and yourself.
-- Lupus -- FDA hopes to stimulate drug
development for this chronic disease.
-- Medication errors -- Health experts work to minimize the potential for confusion
between products with names that look or sound alike.
-- Antiperspirants -- These products can
safely and effectively reduce perspiration.
-- Gender differences -- Health risks
are different for men and women, and treatments may be,
too.
-- Computer-assisted surgery -- The da
Vinci Surgical System is being used in several types of
surgery.
-- Healthier eating for kids -- New
information is aimed at helping children improve eating
habits.
The issue is online at http://www.fda.gov/fdac/405_toc.html.
Subscribe to print version of
FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html.
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RECALLS/SAFETY ALERTS
Nabisco Oreo Thin Crisps Baked
Chocolate Wafer Snacks, 4.86-oz. size
Reason for recall: mislabeled; undeclared milk
http://www.fda.gov/oc/po/firmrecalls/nabisco07_05.html
Reason for recall: possible Salmonella contamination
http://www.fda.gov/oc/po/firmrecalls/orchidislandjuice07_15.html
Lappert's Banana Caramel Chocolate
Chip Ice Cream, 1-pint size
Reason for recall: possible
Listeria monocytogenes
contamination
http://www.fda.gov/oc/po/firmrecalls/lappert07_05.html
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.]
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RECENT SPEECHES
July 14 -- FDA Acting Commissioner Lester
M. Crawford, D.V.M., spoke before the FTC/DHHS Conference on Marketing,
Self-Regulation, and Childhood Obesity
Subject: childhood
obesity
http://www.fda.gov/oc/speeches/2005/ftc0714.html
To view an archive of past
speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
__________________________________________________
PUBLIC MEETINGS
July 20 -- Public Workshop on Leukocyte
Reduction of Blood and Blood Components
Location: Bethesda,
Md.
http://www.fda.gov/cber/meetings/leuko072005.htm
July 21 -- Blood Products Advisory
Committee
Under discussion: updates on several
recent blood-related workshops
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d072105.html
July 22 -- Research Review Subcommittee of the
Blood Products Advisory Committee
Under discussion: a research program
to facilitate development of biological products
Location: Gaithersburg,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber19516d072205.html
July 29 -- Cellular, Tissue and Gene Therapies
Advisory Committee
Under discussion: pertinent FDA
research programs
Location: Rockville,
Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber12389d072905.html
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
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QUESTION OF THE
WEEK
What is a dietary
supplement?
Congress defined the term "dietary
supplement" in the Dietary Supplement Health and Education Act (DSHEA)
of 1994. A dietary supplement is a product taken by mouth that contains a
"dietary ingredient" intended to supplement the diet. The dietary ingredients in
these products may include: vitamins, minerals, herbs or other botanicals, amino
acids, and substances such as enzymes, organ tissues, glandulars, and
metabolites. Dietary supplements also can be extracts or concentrates, and may
be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or
powders. They also can be in other forms, such as a bar, but if they are,
information on their label must not represent the product as a conventional food
or a sole item of a meal or diet. Whatever their form may be, DSHEA places
dietary supplements in a special category under the general umbrella of "foods,"
not drugs, and requires that every supplement be labeled a dietary
supplement.
-- More information: http://www.cfsan.fda.gov/~dms/supplmnt.html
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