FDA News Digest for November 5, 2007

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FDA News Digest

November 5, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  FDA Probe Shows That Consumers Continue to Buy Risky Drugs Online

    --  Manufacturer Agrees to Suspend Marketing of Bleeding-Control Drug Trasylol

    --  More Than $300,000 in Drugs, Supplements Seized From St. Louis Company

    --  FDA Requests Recall of Illegal 'True Man' and 'Energy Max' Drug Products

»  Congressional Testimony

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS
 
FDA Probe Shows That Consumers Continue to Buy Risky Drugs Online
A yearlong FDA investigation suggests that consumers may be buying drugs online to avoid the need to get a prescription from their doctor. An agency sampling of imported drugs also indicates that consumers continue to spend money unnecessarily on potentially risky drugs bought online.
 
Manufacturer Agrees to Suspend Marketing of Bleeding-Control Drug Trasylol
Bayer Pharmaceuticals Corp. has agreed to suspend marketing of Trasylol, a drug used to control bleeding during heart surgery, pending a detailed review of preliminary results from a study that suggests an increased risk of death.
 
More Than $300,000 in Drugs, Supplements Seized From St. Louis Company
At FDA's request, U.S. marshals have seized more than $300,000 in human and animal drugs, dietary supplements, and ingredients to make these products from St. Louis-based General Therapeutics Corp. FDA says the products were maintained under unsanitary conditions, and some of the products lacked FDA approval.
 
FDA Requests Recall of Illegal 'True Man' and 'Energy Max' Drug Products
FDA has asked America True Man Health Inc. to recall its True Man Sexual Energy Nutrient Capsules and Energy Max Energy Supplement Men's Formula Capsules because the agency considers the products to be illegal drugs that contain potentially harmful ingredients. The products are often advertised as "all-natural" alternatives to approved erectile dysfunction (ED) drugs, but they contain substances similar in structure to approved ED drugs.
 
To view an archive of past FDA news releases, go to

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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CONGRESSIONAL TESTIMONY

 

Nov. 1 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations.

    Subject: FDA's foreign drug inspection program

http://www.fda.gov/ola/2007/foreigndrugs110107.html

 

To view an archive of past testimony by FDA officials, go to

http://www.fda.gov/ola/listing.html

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SAFETY ALERTS/RECALLS

Animal Product Recall:
 
›  One lot of Hartz Vitamin Care for Cats
Reason for recall: possible Salmonella contamination
 
Food Recalls:
 
›  The Dutch Kettle Hickory BBQ Sauce, marketed under 35 private labels in 13 states, 19-oz. size (see release for complete list)
Reason for recall: fish component not declared on label
›  Certain lots of Kroger brand Smoked Salmon Dip, 7.5-oz. size
Reason for recall: possible Listeria monocytogenes contamination
  
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

 

Nov. 8-9 -- "Anthrax Vaccines -- Bridging Correlates of Protection in Animals to Immunogenicity in Humans"

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-11613.htm

 

For a complete list of FDA meetings, seminars, and other public events, go to

http://www.fda.gov/opacom/hpmeetings.html.

 

 

CONSUMER HEALTH INFORMATION

 

Each week in FDA News Digest, we will spotlight consumer health information by offering links to timely articles about FDA activities and products the agency regulates.

 

Here's what's in the spotlight this week:

 

› A Ready Supply of Influenza Vaccine

http://www.fda.gov/consumer/updates/influenzavaccine102307.html

› Medtronic Recalls Sprint Fidelis Cardiac Leads; Questions and Answers for Consumers

http://www.fda.gov/consumer/updates/medtronic101507.html

› FDA’s New Generic Drug Program: Qs & As with Gary Buehler, R.Ph.

http://www.fda.gov/consumer/updates/genericsqa100407.html

 

FDA offers a free e-newsletter that contains information posted on FDA's consumer health Web page. To subscribe, go to http://www.fda.gov/consumer/consumerenews.html

 

For those who are members of the press or who manage Web sites, we encourage you to link to this information or incorporate it into your online or printed publications. (We'd appreciate a credit to "FDA Consumer Health Information.")

Questions or comments about our consumer stories or the consumer health e-newsletter? Send an e-mail to fdaconsumerlist@xxxxxxxxxx.  

 

 

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