FDA News Digest
April 18,
2005
______________________________________________
IN THIS WEEK'S
ISSUE
-- FDA Warns About Off-Label Use of
Antipsychotics in Elderly With Dementia
-- FDA Offers Patient Information on
Recently Approved Medical Devices
-- Recalls/Market
Withdrawals
-- Recent Speeches
-- Public Meetings
___________________________________________________________
FDA Warns About 'Off-Label' Use of
Antipsychotics in Elderly With Dementia
FDA is alerting doctors, patients,
and caregivers about studies showing that the "off-label" use of antipsychotic
drugs to treat behavioral disorders in elderly patients with dementia is
associated with a higher death rate when compared to patients receiving a
placebo. FDA is asking all manufacturers of these drugs to add a boxed warning
describing this risk. Antipsychotics are approved only to treat schizophrenia
and mania, but doctors can prescribe them for other uses (so-called "off-label"
use) if they see a benefit.
http://www.fda.gov/bbs/topics/ANSWERS/2005/ANS01350.html
FDA Offers Patient Information on
Recently Approved Medical Devices
FDA's Center for Devices and
Radiological Health has published consumer information on three recently
approved medical devices. The information, linked on the following list, briefly
describes the devices, explains what they are intended to do, and tells how they
should and should not be used.
-- URYX Urethral Bulking Agent (treats
women with stress urinary incontinence)
http://www.fda.gov/cdrh/mda/docs/p030030.html
-- Nuflexxa (1% Sodium Hyaluronate) (treats
pain from osteoarthritis of the knee in patients who have not responded to
non-drug treatments)
http://www.fda.gov/cdrh/mda/docs/p010029.html
-- Kodak Mammography CAD Engine (helps
radiologists improve accuracy of reading mammograms)
http://www.fda.gov/cdrh/mda/docs/p030007.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
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RECALLS/MARKET
WITHDRAWALS
The following products are being
recalled for the reasons shown. Go to the linked pages for more
information.
Certain lots of Jello brand
SugarFree, FatFree, ReducedCalorie Instant
Pudding and Pie Filling; white chocolate, chocolate, and chocolate fudge flavors
(undeclared pistachios)
http://www.fda.gov/oc/po/firmrecalls/kraft04_05.html
Certain varieties of President's
Choice baby foods (may contain bacteria)
http://www.fda.gov/oc/po/firmrecalls/cfia04_05.html
Pocky chocolate sticks; 2-oz.
(undeclared milk)
http://www.fda.gov/oc/po/firmrecalls/market04_05.html
Ziyad brand tahini (possible
Salmonella Senftenberg contamination)
http://www.fda.gov/oc/po/firmrecalls/ziyad04_05.html
Roleski brand Majonez (undeclared
eggs)
http://www.fda.gov/oc/po/firmrecalls/impol04_05.html
For a list of recalls, market
withdrawals, and safety alerts involving FDA-regulated products from the last 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
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RECENT
SPEECHES
FDA Acting Commissioner Lester M.
Crawford, D.V.M., before the Food and Drug Law Institute's annual conference
(April 7)
http://www.fda.gov/oc/speeches/2005/fdli0407.html
To view an archive of past speeches
by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm
____________________________________________________________
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html
_____________________________________________________________
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