December 19, 2005
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IN THIS WEEK'S ISSUE
» News
-- FDA Takes Action Against Fraudulent Bird Flu Therapies
-- Many 'Canadian' Drugs Originate Elsewhere, FDA Operation Finds
-- Spurring Medical Innovation Is Goal of FDA/C-Path Partnership
-- 100th Drug Has Special Labeling for Use in Children
-- FDA 'Encouraged' by Reopening of Japanese Market to U.S. Beef
» Recalls/Safety Alerts
» Congressional Testimony
»
Question of the
Week
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FDA Takes Action Against Fraudulent Bird Flu Therapies
FDA has sent warning letters to nine companies marketing products with fraudulent claims of effectiveness in preventing avian (bird) flu and other forms of flu. The agency, which has seen no evidence that the products are safe and effective, is concerned that these products could harm consumers or interfere with conventional treatments.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01274.html
-- Flu information: http://www.fda.gov/oc/opacom/hottopics/flu.html
Many 'Canadian' Drugs Originate Elsewhere, FDA Operation Finds
An FDA operation has found that 85 percent of imported drugs intercepted recently from four countries that were promoted as coming from Canadian pharmacies actually were manufactured in 27 different countries. FDA says the operation underscores its warnings that some Web sites for so-called "Canadian" pharmacies may sell counterfeit products or ones that are not safe and effective.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01277.html
Spurring Medical Innovation Is Goal of FDA/C-Path Partnership
FDA has joined with the newly formed Critical Path Institute (C-Path) to help advance the goals of the agency's Critical Path Initiative, which seeks to improve the efficiency and safety of medical product development. One of the first partnership projects will be the Community Pharmacy Safety Network, which will give patients the opportunity to actively participate in their care by providing valuable information on medicine outcomes.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01276.html
-- Critical Path information: http://www.fda.gov/oc/initiatives/criticalpath/
100th Drug Has Special Labeling for Use in Children
Trileptal, a drug to treat seizures, is the 100th medicine to include information in its labeling about the product's use in children and teenagers, as required by laws passed in the last eight years. The legislation created incentives for companies that perform research to determine the safety, effectiveness, dosing, and unique risks for medicines to be taken by children.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01280.html
FDA 'Encouraged' by Reopening of Japanese Market to U.S. Beef
Commenting on the Japanese government's decision to lift its temporary ban on imports of U.S. beef products, FDA Acting Commissioner Andrew von Eschenbach, M.D., says FDA is "encouraged by" the reopening of the Japanese market. He adds that Japan's action acknowledges measures the United States has taken to protect against bovine spongiform encephalopathy (BSE, or "mad cow disease").
-- Statement: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01273.html
-- BSE information: http://www.fda.gov/oc/opacom/hottopics/bse.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
Recalls:
One lot of Methotrexate for Injection
Reason for recall: active drug substance contains low levels of ethylene glycol
http://www.fda.gov/oc/po/firmrecalls/bedford12_05.html
Baxter Healthcare's Meridian Hemodialysis Instrument
Reason for recall: reports of hemolysis (red blood cell destruction)
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01275.html
Certain cheeseburger and chicken biscuit products under the Jimmy Dean, Rudy's Farm, and State Fair brands
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/saralee12_05.html
Woodsmoke Provisions' Premium Smoked Salmon Pastrami Style: 4-oz. size
Reason for recall: possible Listeria monocytogenes contamination
http://www.fda.gov/oc/po/firmrecalls/woodsmoke12_05.html
Hong Kong Supermarket brand dried vegetable
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/monchongloong12_05.html
Safety Alerts:
FDA is alerting healthcare providers about the market withdrawal of the diagnostic imaging agent NeutroSpec [Technetium (99m TC) Fanolesomab] following reports of allergic reactions that resulted in two reported deaths and other serious adverse effects. NeutroSpec is used to diagnose appendicitis in patients five years and older who lack conventional appendicitis symptoms.
-- Press release: http://www.fda.gov/bbs/topics/NEWS/2005/NEW01279.html
-- More information: http://www.fda.gov/cder/drug/infopage/technetium99/default.htm
Following a disease outbreak in Washington state, FDA is warning consumers not to drink raw milk because it may contain harmful bacteria that can cause life-threatening illnesses. Raw milk is not treated to remove disease-causing bacteria. Officials traced the Washington outbreak to an unlicensed dairy that has been ordered to shut down.
http://www.fda.gov/bbs/topics/NEWS/2005/NEW01278.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.
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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CONGRESSIONAL TESTIMONY
What ingredients are prohibited from use in cosmetics?
With the
exception of color additives and a few prohibited ingredients, a cosmetic
manufacturer may use almost any raw material as a cosmetic ingredient and market
the product without approval from FDA. The Federal Food, Drug, and Cosmetic Act
requires that color additives used in cosmetics must be tested for safety and be
listed by the FDA for their intended uses.
Regulations restrict or prohibit the use of the following ingredients in cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated salicyanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene chloride, chlorofluorocarbon propellants and hexachlorophene.
In the early 1970s, FDA received a number of complaints of personal injury associated with the use of fingernail extenders containing methyl methacrylate monomer. On the basis of its investigations of the injuries and discussions with medical experts in the field of dermatology, FDA concluded that liquid methyl methacrylate was a poisonous substance that should not be used in fingernail preparations. The agency chose to remove products containing 100 percent liquid methyl methacrylate monomer through court proceedings, which resulted in a preliminary injunction against one firm as well as several seizure actions and voluntary recalls.
In addition to the ingredients that are controlled by regulation or were the subject of a court ruling, cosmetic and fragrance trade associations have recommended eliminating or limiting the use of certain ingredients associated with health risks.
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