FDA News Digest
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IN THIS WEEK'S ISSUE
» News
--
Strengthening Medical Device Safety is Aim of New FDA
Program
-- Labels
for Eczema Drugs Elidel, Protopic to Warn of Cancer Risk
-- FDA
Takes Measures to Protect Against Bogus Flu Products
-- New
Immune Globulin Product Is Injected Under the Skin
» Recalls/Safety
Alerts
» Upcoming Public
Meetings
» Question of the
Week
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Strengthening Medical Device Safety is Aim of New FDA
Program
FDA's Postmarket Transformation Initiative,
announced Jan. 20, will help the agency identify, analyze, and act more
quickly on potential medical device problems. The initiative focuses on measures
such as establishing an electronic reporting system for medical device adverse
events and improving device information in patients' records. The initiative
aims to aid FDA in evaluating new device technologies with the goal of
maximizing benefits of those products while minimizing their
risks.
-- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01300.html
-- More information: www.fda.gov/cdrh/postmarket/mdpi.html
Labels for Eczema Drugs Elidel, Protopic to Warn of
Cancer Risk
FDA has approved labeling changes for two topical
eczema drugs, Elidel cream and Protopic ointment, to indicate a possible risk of
cancer. The agency has received rare reports of skin cancer and lymphoma in
patients using the products, though no definitive link has been established. The
revised labeling also will indicate that the drugs are recommended as
"second-line treatments," that is, other prescription eczema treatments should
be tried first.
http://www.fda.gov/bbs/topics/news/2006/NEW01299.html
FDA Takes Measures to Protect Against Bogus Flu
Products
Sales of unlicensed or unapproved flu-related
products are a significant public health threat, FDA says. As a result, the
agency is taking measures to protect consumers from these illegal products,
including intercepting bogus products at the
-- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01301.html
-- More flu information: http://www.fda.gov/oc/opacom/hottopics/flu.html
New Immune Globulin Product Is Injected Under the
Skin
FDA has approved Vivaglobin, the first immune
globulin product for injection under the skin that can help prevent serious
infections in patients with primary immune deficiency diseases (PIDDs).
Inherited disorders that affect about 50,000 people in the
http://www.fda.gov/bbs/topics/news/2006/NEW01294.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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RECALLS/SAFETY
ALERTS
Recall:
Roche Diagnostics' Accu-Chek Aviva
meters
Reason for recall: possible
malfunction problems
http://www.fda.gov/oc/po/firmrecalls/roche01_06.html
Safety
Alert:
FDA is alerting the public about three reported cases of serious liver toxicity in patients who took the
antibiotic Ketek (telithromycin). The agency has released
several recommendations for healthcare providers and their patients who
take Ketek which include monitoring for symptoms of liver
problems and using the antibiotic only for appropriate
infections.
http://www.fda.gov/cder/drug/advisory/telithromycin.htm
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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UPCOMING PUBLIC
MEETINGS
Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative
Public Workshop and Vendor Display
Under discussion: adoption
of radio-frequency identification in the
Location:
http://www.fda.gov/rfidmeeting.html
Feb. 8-9 -- Industry Exchange Workshop on FDA
Clinical Trial Requirements
Under discussion:
industry and FDA perspectives on proper conduct of FDA-regulated clinical
trials
Location:
http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18871.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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QUESTION OF THE
WEEK
What changes can I make in my life to
help lower my risk of heart disease?
Choosing a healthy lifestyle can help you reduce the
risk of coronary heart disease or minimize its
damage.
Healthy lifestyles include:
- eating a healthy diet
- maintaining a healthy
weight
- exercising regularly
- quitting (or not starting)
smoking
- minimizing stress
For detailed information on each of
these, see http://www.fda.gov/hearthealth/lifestyles/lifestyles.html.
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