FDA News Digest
January 17, 2006
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IN THIS WEEK'S ISSUE
» News
-- New Guidelines Aim to Boost Early Phases of Drug Development
-- FDA Warns of Confusing Drug Names in Prescriptions Filled Abroad
-- Lipodrene Seized; Contained Prohibited Ephedrine Alkaloids
» Recalls/Safety Alerts
» Upcoming Public Meetings
» Question of the Week
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New Guidelines Aim to Boost Early Phases of Drug Development
FDA has issued guidelines to help advance the earliest phases of clinical
research with the goal of hastening the process for bringing new drug
treatments for serious and life-threatening diseases to market. The
guidelines will allow researchers to evaluate much more efficiently the
promise of medical advances discovered in their laboratories and will help
speed up the transition of these potential treatments into clinical trials.
The guidelines are part of FDA's Critical Path Initiative, which aims to
identify potential drug treatments early in the development stage and reduce
resources expended on products unlikely to succeed.
-- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01296.html
<http://www.fda.gov/bbs/topics/news/2006/NEW01296.html>
-- Acting FDA Commissioner von Eschenbach's remarks:
http://www.fda.gov/oc/speeches/2006/fdateleconference0112.html
<http://www.fda.gov/oc/speeches/2006/fdateleconference0112.html>
FDA Warns of Confusing Drug Names in Prescriptions Filled Abroad
In the United States, the drug Flomax is prescribed to treat an enlarged
prostate. But in Italy, a drug also called Flomax is an anti-inflammatory
treatment. Potential confusions like this underscore FDA's recent warning to
consumers that filling U.S. prescriptions abroad may result in the wrong
active ingredient for their treatments. The agency says 105 U.S. brand names
are so similar to foreign brand names that patients buying the products
overseas (or through foreign Web sites) may end up with the wrong drug,
setting the stage for adverse reactions with no health improvement.
-- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01295.html
<http://www.fda.gov/bbs/topics/news/2006/NEW01295.html>
-- Public health advisory:
www.fda.gov/oc/opacom/reports/confusingnames.html
<http://www.fda.gov/oc/opacom/reports/confusingnames.html>
Lipodrene Seized; Contained Prohibited Ephedrine Alkaloids
U.S. marshals have seized $16,000 worth of Lipodrene, a dietary supplement
containing ephedrine alkaloids (ephedra), which FDA banned from sale in
dietary supplements in 2004. The seizure took place at Pennsylvania-based
ATF Fitness Products Inc. Research has linked ephedra to serious adverse
health effects, including heart attacks and strokes.
-- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01297.html
<http://www.fda.gov/bbs/topics/news/2006/NEW01297.html>
-- More ephedra information:
http://www.fda.gov/oc/initiatives/ephedra/february2004/
<http://www.fda.gov/oc/initiatives/ephedra/february2004/>
To view an archive of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html
<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
<http://www.fda.gov/bbs/topics/news/rssPress.xml> .
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html
<http://www.fda.gov/bbs/topics/news/newsfeeds.html> .]
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RECALLS/SAFETY ALERTS
Recalls:
Whole Foods Market's Whole Catch Lemon Pepper Garlic Hot Smoked Trout
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/wholefoods201_06.html
<http://www.fda.gov/oc/po/firmrecalls/wholefoods201_06.html>
Log House Cherry Flavored Chips, Log House Butterscotch Flavored Chips, and
Hy-Vee Butterscotch Flavored Chips
Reason for recall: undeclared milk
http://www.fda.gov/oc/po/firmrecalls/loghouse01_06.html
<http://www.fda.gov/oc/po/firmrecalls/loghouse01_06.html>
Robert's American Gourmet Wheat Free Chaos Snack Mix; 6-oz. bags
Reason for recall: undeclared wheat
http://www.fda.gov/oc/po/firmrecalls/roberts01_06.html
<http://www.fda.gov/oc/po/firmrecalls/roberts01_06.html>
Safety Alert:
FDA is warning consumers not to use Emagrece Sim Dietary Supplement (also
known as the Brazilian Diet Pill), and Herbathin Dietary Supplement. Both
are unapproved drug products marketed for weight loss and may contain
several active ingredients, including controlled substances, found in
prescription drugs that could lead to serious side effects or injury.
http://www.fda.gov/bbs/topics/news/2006/NEW01298.html
<http://www.fda.gov/bbs/topics/news/2006/NEW01298.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
<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
<http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml> .
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html
<http://www.fda.gov/bbs/topics/news/newsfeeds.html> .]
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UPCOMING PUBLIC MEETINGS
Jan. 20 -- Regulatory Process for Pediatric Mechanical Circulatory Support
Devices (Ventricular Assist Devices)
Under discussion: regulation and approval of circulatory support devices
used for temporary support in pediatric patients
Location: Rockville, Md.
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-24271.htm
<http://www.fda.gov/OHRMS/DOCKETS/98fr/05-24271.htm>
Jan. 23 -- Joint meeting of the Nonprescription Drugs Advisory Committee and
the Endocrinologic and Metabolic Drugs Advisory Committee
Under discussion: pending application for over-the-counter use of the
prescription weight-loss drug Orlistat
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012306.html
<http://www.fda.gov/oc/advisory/accalendar/2005/cber12391dd12141505.html>
Jan. 24 -- Joint meeting of the Nonprescription Drugs Advisory Committee and
the Pulmonary-Allergy Drugs Advisory Committee
Under discussion: the continuing need to designate over-the-counter
epinephrine metered-dose inhalers as an essential use of ozone-depleting
substances
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html
<http://www.fda.gov/oc/advisory/accalendar/2006/cder12541d012406.html>
Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative Public Workshop and Vendor
Display
Under discussion: adoption of radio-frequency identification in the U.S.
medicine supply chain to combat counterfeit products
Location: Bethesda, Md.
http://www.fda.gov/rfidmeeting.html <http://www.fda.gov/rfidmeeting.html>
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
<http://www.fda.gov/opacom/hpmeetings.html> .
_____________________________________________
QUESTION OF THE WEEK
Can the symptoms of foodborne illness be mistaken for the flu?
Yes. Foodborne illness often causes flu-like symptoms such as nausea,
vomiting, diarrhea, or fever, so many people may not recognize that the
illness is caused by bacteria or other pathogens in food.
Experts from the Centers for Disease Control and Prevention (CDC) report
that many of the intestinal illnesses commonly referred to as stomach flu
are actually caused by foodborne pathogens. People do not associate these
illnesses with food because the onset of symptoms often occurs two or more
days after the contaminated food was eaten.
For more on foodborne illness, see
http://www.cfsan.fda.gov/~mow/foodborn.html
<http://www.cfsan.fda.gov/~mow/foodborn.html> .
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