FDA News Digest for May 14, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

May 14, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    -- Company Agrees to $600 Million Settlement in OxyContin Scheme

    -- Skin Patch OK'd to Treat Symptoms of Early Parkinson's Disease

    -- FDA Clears First Respirators for Use in Public Health Emergencies

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Upcoming Public Meetings

»  Question of the Week

»  New Postings on FDA.gov

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NEWS

 

Company Agrees to $600 Million Settlement in OxyContin Scheme

The Purdue Frederick Company Inc. has agreed to pay more than $600 million to resolve criminal charges and civil liabilities in connection with several illegal schemes to promote, market and sell OxyContin, a powerful prescription pain reliever. An FDA investigation revealed that the company had trained its sales force to make false statements to health care providers as a ploy to generate maximum revenues.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01632.html

 

Skin Patch OK'd to Treat Symptoms of Early Parkinson's Disease

FDA has approved Neupro, a skin patch designed to treat the symptoms of early Parkinson's disease. Parkinson's is a debilitating disorder affecting more than 1 million Americans, with 60,000 new cases diagnosed yearly. Neupro contains rotigotine, a drug known as a dopamine agonist, which mimics dopamine in the brain to counteract the loss of dopamine-producing brain cells characteristic in Parkinson's patients.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01631.html

 

FDA Clears First Respirators for Use in Public Health Emergencies

FDA has cleared the 3M Respirator 8612F and 8670F, the first of their kind to help reduce exposure to airborne germs during a public health emergency such as a flu pandemic. The devices, which will be available to the public, are designed to filter out at least 95 percent of tiny airborne particles.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01630.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

Pet Food Recall:

 

›  FDA has a special page that lists the latest information on brands of pet foods being recalled. 

http://www.fda.gov/oc/opacom/hottopics/petfood.html

 

Food Recalls:

 

›  Certain lots of Gurley's Golden Recipe Cranberry Trail Mix, 7.25 oz. size

   Reason for recall: sulfites in product not listed (allergy hazard)

http://www.fda.gov/oc/po/firmrecalls/gurley05_07.html

›  Certain lots of Hostess Mini Pound Cakes, 3.25 oz. size

    Reason for recall: mispackaged product may include walnuts (allergy hazard)

http://www.fda.gov/oc/po/firmrecalls/interstate05_07.html

›  Certain lots of Mayfield Turtle Tracks ice cream, 1.75 qt. size

   Reason for recall: peanuts in product not listed (allergy hazard)

http://www.fda.gov/oc/po/firmrecalls/mayfield05_07.html

›  Raw milk from Misty Meadow Farm (Berks County, Pa.)

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/mistymeadow05_07.html

 

Safety Alert:

 

›  FDA is advising consumers not to buy or use "True Man" or "Energy Max" products, touted for sexual enhancement and as treatments for erectile dysfunction. Both products are illegal drugs that contain potentially harmful ingredients not listed in the labeling. The drugs contain substances that are similar to active ingredients in approved prescription drugs. FDA is especially concerned because consumers may use these products unaware that the ingredients in them can interact with other medications and cause dangerously low blood pressure.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01633.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

 

May 9 -- FDA Center for Drug Evaluation and Research Director Steven Galson, M.D., appeared before the House Subcommittee on Health

    Subject: modernizing drug safety

http://www.fda.gov/ola/2007/drugsafety050907.html

 

May 9 -- FDA Assistant Commissioner for Food Protection David Acheson, M.D., appeared before the House Committee on Agriculture

    Subject: importation of contaminated animal feed ingredients and the impact on food safety and animal health

http://www.fda.gov/ola/2007/melamine050907.html

 

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

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

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UPCOMING PUBLIC MEETINGS

 

May 16-17 -- Vaccines and Related Biological Products Advisory Committee

    Under discussion: evaluation of two vaccines

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-7090.htm

 

May 16-17 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

    Under discussion: industry and FDA perspectives on proper conduct of FDA-regulated clinical trials

     Location: Oak Brook, Ill.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-5633.htm

 

June 12-13 -- Public hearing to obtain feedback on FDA's Medication Guide program

    Location: Washington, D.C.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01606.html

 

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

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

 

 

QUESTION OF THE WEEK

 

Are there risks in getting a tattoo?

 

Yes. Here are some:

 

» Dirty tattoo needles can pass infections from one person to another person. These can be serious like hepatitis and HIV. Make sure that the needles are clean and germ-free.

» You might be allergic to something used in your tattoo. This is rare, but it could cause serious problems.

» Lumps or bumps may form around the tattoo color.

» You could have swelling or burning in the tattoo if you have magnetic resonance imaging (MRI). However, this happens rarely and does not last very long.

» You may not like your tattoo even if it was done well. Not liking the tattoo is the most common reason people give for having one removed.

» If you decide you want to get rid of a tattoo, it usually takes many treatments and costs a lot of money.

» Scars may form when getting or removing a tattoo.

 

For more information on tattoos, see http://www.fda.gov/oc/opacom/hottopics/tattoos.html.

 

 

NEW POSTINGS ON FDA.GOV

 

FDA has recently posted:

 

» an upgraded Web page that lists recalls, market withdrawals

and safety alerts from the last 60 days. The page also provides

the capability of searching recall information by company name

or product name as far back as 1999

http://www.fda.gov/opacom/7alerts.html

 

» a Web page containing outdoor eating food safety tips to help

prevent foodborne illness when preparing, stroring and cooking food

for picnics and barbecues.

http://www.cfsan.fda.gov/~dms/fssumme2.html

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