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FDA has expanded the approval of Plavix (clopidogrel bisulfate) to treat patients after they have had a common type of heart attack called an acute ST-segment elevation myocardial infarction (STEMI), which results from total artery blockage. Plavix decreases the tendency for sticky blood cells called platelets to clump together and form clots, which can block blood vessels. An estimated 500,000 Americans have STEMI heart attacks yearly.
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01431.html
Inspection Prompts Shutdown Order for Human Tissue Firm
Following an inspection that uncovered serious problems, FDA has ordered North Carolina-based Donor Referral Services to stop manufacturing human cells, tissues, and cellular and tissue-based products. The agency found deficiencies in the company's manufacturing practices, including those governing donor screening and recordkeeping. FDA said continued operation of the facility "would present a danger to public health."
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01433.html
Refunds Available for Three Unapproved Lane Labs Products
FDA is notifying consumers who bought any of three Lane Labs products -- BeneFin, MGN-3, or Skin Answer -- that they are eligible for a partial refund. A New Jersey federal court ordered the company to pay back customers who bought the products between Sept. 22, 1999 and July 12, 2004. The court ruled that the products, touted as treatments for cancer and HIV, were marketed without FDA approval.
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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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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RECENT SPEECHES
August 17 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke at the Massachusetts Institute of Technology's Center for Biomedical Innovation
Subject: monitoring new medicines after they are approved
http://www.fda.gov/oc/speeches/2006/mit0817.html
To view an archive of past speeches by FDA officials, go to
http://www.fda.gov/speeches/speechli.htm.
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UPCOMING PUBLIC MEETINGS
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
QUESTION OF THE WEEK
Can the symptoms of foodborne illness be mistaken for something else?
Yes.
Foodborne illness often shows itself as flu-like symptoms such as nausea,
vomiting, diarrhea, or fever, so many people may not recognize that the illness
is caused by bacteria or other pathogens in
food.
The Centers for Disease Control and Prevention (CDC) reports that many of the intestinal illnesses commonly referred to as stomach flu are actually caused by foodborne pathogens. People do not associate these illnesses with food because the onset of symptoms often occurs two or more days after the contaminated food was eaten.
For more on foodborne illness, see http://www.cfsan.fda.gov/~mow/foodborn.html.
__________________________________________________How's your knowledge of health topics such as the flu, cold medicines, artificial sweeteners, and smoking? Find out by taking our FDA Consumer health quiz at http://www.fda.gov/fdac/quiz/onlinequiz30_js.html.
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