FDA News
Digest
October 3, 2005
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IN THIS WEEK'S ISSUE
-- FDA Warns of Suicidal Thoughts in Users of ADHD Drug Strattera
-- Rule Finalized for Requiring Registration of Food Facilities
-- 2005 Food Code Updates Food Safety Guidelines for Industry
-- Latest FDA Consumer Magazine Available Online
-- Upcoming
Public Meetings
-- Question of the
Week
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FDA Warns of Suicidal Thoughts in Users of ADHD Drug Strattera
Following review of more than a dozen clinical trials, FDA is alerting health care professionals about reports of suicidal thinking in children and adolescents who take Strattera, a drug for attention deficit hyperactivity disorder. The agency advises close monitoring of patients on the drug for suicidal thoughts and other unusual changes in behavior, especially when the dose is changed. More than two million patients have used Strattera since the drug was first marketed in 2002.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01237.html
Rule Finalized for Requiring Registration of Food Facilities
FDA has issued a final rule requiring registration of all domestic and foreign facilities that manufacture, process, pack, or hold food for consumption in the United States. The rule will help FDA identify and quickly locate food facilities in the event of deliberate or accidental contamination of the food supply. The rule is one of five regulations FDA has issued to implement the Bioterrorism Act of 2002.
http://www.fda.gov/bbs/topics/news/2005/new01236.html
2005 Food Code Updates Food Safety Guidelines for Industry
FDA has issued the 2005 Food Code, which contains the latest science-based information on food safety for food service organizations. About 3,000 regulatory agencies use the Food Code as a reference to aid in oversight of food safety in restaurants, grocery stores, nursing homes, and other retail and institutional settings.
http://www.fda.gov/bbs/topics/news/2005/new01235.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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The September-October 2005 issue of
FDA Consumer has articles on these topics:
-- Saving money on prescription
drugs -- These strategies can help lower your medicine
bill.
-- Epilepsy - New research is improving
our understanding of
the underlying causes of this disease.
-- Mammograms -- They can
detect breast cancer early, when it's most treatable.
-- Choking hazards -- How
to reduce choking risks for your child.
-- Pediatric medical
devices -- Specially designed devices can meet children's short- and
long-term needs.
-- Urinary incontinence --
Treatments are available to cure or improve this frustrating
problem.
-- New heart drug for black
patients -- BiDil can reduce death and
hospitalization.
The issue is online at http://www.fda.gov/fdac/505_toc.html.
Subscribe to the print version of
FDA Consumer: http://www.fda.gov/fdac/orderform/fdap.html
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RECALLS/SAFETY ALERTS
Recalls:
All lots of injectable chemotherapy drug Fluorouracil; 50 mg/10 mL (500 mg/10 mL single dose vial)
Reason for recall: possible glass particles in the vials
http://www.fda.gov/medwatch/safety/2005/safety05.htm#Fluorouracil
Safety Alerts:
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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http://www.fda.gov/ola/listing.html.
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RECENT SPEECHES
Sept. 28 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the National Press Club.
Subject: "Dismantling Barriers to Better Medical
Information"
http://www.fda.gov/oc/speeches/2005/npc0928.html
To view an archive of past
speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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Oct. 11 -- Cardiac Safety and the Critical Pathway Initiative Think Tank symposium offers an opportunity to participate in helping to shape the future of cardiac safety testing and its impact on drug and device development.
Location: Bethesda, Md.
https://banquo.duhs.duke.edu/dcri/coresearchreg.nsf/core
Oct. 11-12 -- Dental Products Panel of the Medical Devices Advisory Committee
Under discussion: recommendations on classification of seven unclassified dental devices
Location: Gaithersburg, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cdrh12518dd10111205.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 liposuction?
Liposuction is a surgical procedure intended to
remove fat deposits and shape the body. Fat is removed from under the skin with
the use of a vacuum-suction canula (a hollow pen-like instrument) or using an
ultrasonic probe that breaks fat up
into small pieces and then removes it with
suction. Persons with localized fat may decide to have
liposuction to remove fat from that area. Liposuction is intended to shape the body and is not recommended for weight
loss.
Liposuction may be performed on
the abdomen, hips, thighs, calves, arms, buttocks, back, neck, or face. A
liposuction procedure may include more than one site, for instance, the abdomen,
back, and thighs all on the same day.
Liposuction is also used to reduce breast size in men with large breasts (gynecomastia) or to remove fat tumors (lipomas), but it is most commonly used for cosmetic body shaping.
Want to learn more? Go to http://www.fda.gov/cdrh/liposuction/.
__________________________________________________HOW'S YOUR KNOWLEDGE of health topics such as generic drugs, mammograms, epilepsy, or pediatric drugs? Find out by taking our online quiz at http://www.fda.gov/fdac/quiz/onlinequiz25_js.html.
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