FDA News
Digest
December 12, 2005
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IN THIS WEEK'S ISSUE
» News
-- Tests Show Hurricanes Did Not Contaminate Gulf Coast Seafood
-- Public Warned Not to Use Contaminated 'Miracle II' Products
-- Ephedra-Containing 'Nature's Treat' Supplements Seized
-- Latest 'Patient Safety News' Video Available Online
» Recalls/Safety Alerts
» Recent Speeches
»
Upcoming Public
Meetings
»
Question of the
Week
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Tests Show Hurricanes Did Not Contaminate Gulf Coast Seafood
Following analyses of hundreds of fish and shellfish samples from waters affected by Hurricanes Katrina and Rita, FDA says there is no reason for concern about eating seafood from the Gulf area. FDA worked with other federal and state agencies to analyze for chemical and microbiological contaminants the hurricanes could have introduced.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01271.html
Public Warned Not to Use Contaminated 'Miracle II' Products
FDA has warned consumers not to use Miracle II Neutralizer or Miracle II Neutralizer Gel products because they are contaminated with bacteria and have not been proven safe and effective. Marketer Tedco Inc. has promoted the products for treatment of cataracts, AIDS, cancer, diabetes and other unapproved uses, which FDA calls "deceptive and untruthful claims."
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01268.html
Ephedra-Containing 'Nature's Treat' Supplements Seized
U.S. marshals have seized nearly 3,000 bottles of Nature's Treat Energy Plus #1 dietary supplement from two distributors. FDA determined that the products contained ephedra, an herbal source of ephedrine alkaloids, which the agency has prohibited from sale in dietary supplements since 2004.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01267.html
Latest 'Patient Safety News' Video Available Online
FDA has posted the December edition of "Patient Safety News," a Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls. Topics covered include the risk of suicidal thinking in children treated with the attention-deficit drug Strattera.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
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
Recalls:
Giant brand Chocolate Chip Chewy Granola Bars; 10-oz. cartons
Reason for recall: label on cartons doesn't state that contents may contain peanuts
http://www.fda.gov/oc/po/firmrecalls/conagra12_05.html
Stainless Steel Greenfield Vena Cava Filters with 12Fr Femoral Introducer Systems (made before March 10, 2004)
Reason for recall: device problems could cause serious adverse effects
http://www.fda.gov/oc/po/firmrecalls/bostonsci12_05.html
Safety Alert:
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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Dec. 8 -- FDA Deputy Commissioner for
Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the Part 15 Hearing on Risk Communication
Dec. 8 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the American Pain Foundation
Subject: safe use of new pain treatments
http://www.fda.gov/oc/speeches/2005/apf1208.html
To view an archive
of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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Dec. 14-15 -- Vaccines and Related Biological Products Advisory Committee
Under discussion: safety and effectiveness of a rotavirus vaccine and a zoster vaccine
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2005/cber12391dd12141505.html
Dec. 15 -- Joint FDA/USDA meeting to
discuss a consistent regulatory approach concerning the jurisdiction over
certain products containing meat or poultry.
Location: Rosemont,
Ill.
http://www.fda.gov/bbs/topics/news/2005/NEW01255.html
For a list of FDA meetings,
seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
Is there a link between antiperspirant use and breast cancer?
FDA is aware of concerns that antiperspirant use -- in conjunction with underarm shaving -- may be associated with increased risk of developing breast cancer. FDA continues to search scientific literature for studies examining this possible adverse drug effect. Unfortunately, there are many publications that discuss the issue but very few studies in which data have been collected and analyzed. Overall, the studies that contain data are inconclusive in determining whether antiperspirants, in any way, contribute to the development of breast cancer. FDA hopes that definitive studies exploring breast cancer incidence and antiperspirant use will be conducted in the near future.
For more
information, go to http://www.fda.gov/oc/opacom/hottopics/antiperspirant.html.
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