FDA News Digest for June 19, 2006

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest     

June 19, 2006

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IN THIS WEEK'S ISSUE

»  News

    -- First Drug Approved to Treat Late-Stage Cervical Cancer

    -- Campaign Aims to Reduce Errors Caused by Unclear Abbreviations

    -- N.Y., Conn. Take Action Against Illegal Massage Devices

»  Recalls/Safety Alerts

»  Congressional Testimony

»  Recent Speeches

»  Upcoming Public Meetings

»  Question of the Week

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NEWS

 

First Drug Approved to Treat Late-Stage Cervical Cancer

FDA has approved a combination of the drugs Hycamptin and cisplatin as the first treatment for late-stage cervical cancer when surgery or radiation are unlikely to be effective. There are about 10,000 new cases of cervical cancer a year and 3,700 deaths. FDA says the new drug combination is "a potentially life-prolonging option for thousands of women."

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01391.html

 

Campaign Aims to Reduce Errors Caused by Unclear Abbreviations

FDA and the Institute for Safe Medication Practices have launched a campaign with the goal of reducing the number of medication mixups and mistakes caused by using medical abbreviations. The campaign seeks to eliminate common notations such as "IU," which is sometimes misinterpreted to read "IV" or "10." More than 7,000 die yearly because of medication errors, according to the Institute of Medicine.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01390.html

 

N.Y., Conn. Take Action Against Illegal Massage Devices

In New York, the federal government has seized more than $2.7 million worth of two types of unapproved medical devices touted to treat arthritis, migraine headaches, multiple sclerosis, and other serious medical conditions. In Connecticut, the government is seeking to seize about $1 million worth of the same products. The devices, Dr-Ho's Double Massage and Dr-Ho's Muscle Massage, are considered adulterated and misbranded under federal law.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01389.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

Device Recall:

 

Certain Welch Allyn AED20 Automated External Defibrillators, manufactured April through October 2003

    Reason for recall: electrical problem could cause device malfunction or failure

-- Press release: http://www.fda.gov/oc/po/firmrecalls/mrl06_06.html

-- Recall notice: http://www.fda.gov/cdrh/recalls/recall-061506.html

 

Drug Recall:

 

Triaminic Vapor Patch

    Reason for recall: children could remove the patch and chew on it causing potentially serious health effects

http://www.fda.gov/oc/po/firmrecalls/novartis6_06.html

 

Food Recall: 

 

Cahill's Farm Porter Cheese; 4.5-7 oz. sizes

    Reason for recall: possible Listeria monocytogenes contamination

http://www.fda.gov/oc/po/firmrecalls/swissamerican06_06.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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CONGRESSIONAL TESTIMONY

 

June 15 -- FDA Center for Devices and Radiological Health Director Daniel Schultz, M.D., testified before the House Committee on Veteran's Affairs

    Subject: sterility of medical devices

http://www.fda.gov/ola/2006/devices0615.html

 

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

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

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RECENT SPEECHES

 

June 12 -- FDA Deputy Commissioner for Medical and Scientific Affairs Scott Gottlieb, M.D., spoke before the American Medical Association.

    Subject: drug safety

http://www.fda.gov/oc/speeches/2006/ama0612.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

July 12 -- FDA Workshop on Testing for Malarial Infections in Blood Donors

    Under discussion: current information that might support donor testing for malaria as part of screening

    Location: Bethesda, Md.

http://www.fda.gov/cber/meetings/malaria071206.htm

 

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

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

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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.

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How's your knowledge of health topics such as medical devices, prostate cancer, and "restless leg syndrome"? Find out by taking our health quiz at http://www.fda.gov/fdac/quiz/onlinequiz29_js.html.

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