FDA News Digest for January 23, 2006

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Title: Message

FDA News Digest

January 23, 2006

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IN THIS WEEK'S ISSUE

»  News

    --  Strengthening Medical Device Safety is Aim of New FDA Program

    --  Labels for Eczema Drugs Elidel, Protopic to Warn of Cancer Risk

    --  FDA Takes Measures to Protect Against Bogus Flu Products

    --  New Immune Globulin Product Is Injected Under the Skin

»  Recalls/Safety Alerts

»  Upcoming Public Meetings

»  Question of the Week

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Strengthening Medical Device Safety is Aim of New FDA Program

FDA's Postmarket Transformation Initiative, announced Jan. 20, will help the agency identify, analyze, and act more quickly on potential medical device problems. The initiative focuses on measures such as establishing an electronic reporting system for medical device adverse events and improving device information in patients' records. The initiative aims to aid FDA in evaluating new device technologies with the goal of maximizing benefits of those products while minimizing their risks.

    -- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01300.html

    -- More information: www.fda.gov/cdrh/postmarket/mdpi.html

 

Labels for Eczema Drugs Elidel, Protopic to Warn of Cancer Risk

FDA has approved labeling changes for two topical eczema drugs, Elidel cream and Protopic ointment, to indicate a possible risk of cancer. The agency has received rare reports of skin cancer and lymphoma in patients using the products, though no definitive link has been established. The revised labeling also will indicate that the drugs are recommended as "second-line treatments," that is, other prescription eczema treatments should be tried first.

http://www.fda.gov/bbs/topics/news/2006/NEW01299.html

 

FDA Takes Measures to Protect Against Bogus Flu Products 

Sales of unlicensed or unapproved flu-related products are a significant public health threat, FDA says. As a result, the agency is taking measures to protect consumers from these illegal products, including intercepting bogus products at the U.S. border and pursuing criminal charges against those who peddle bogus flu products. FDA stresses that currently there are no approved vaccines for preventing avian (bird) flu, nor are there any drugs approved for treating specific bird flu symptoms.

    -- Press release: http://www.fda.gov/bbs/topics/news/2006/NEW01301.html

    -- More flu information: http://www.fda.gov/oc/opacom/hottopics/flu.html

 

New Immune Globulin Product Is Injected Under the Skin

FDA has approved Vivaglobin, the first immune globulin product for injection under the skin that can help prevent serious infections in patients with primary immune deficiency diseases (PIDDs). Inherited disorders that affect about 50,000 people in the United States, PIDDs require regular treatment with immune globulin to fight off or prevent potentially serious infections. Other immune globulin products are injected into the vein or muscle.

http://www.fda.gov/bbs/topics/news/2006/NEW01294.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

 

Recall:

 

Roche Diagnostics' Accu-Chek Aviva meters

    Reason for recall: possible malfunction problems

http://www.fda.gov/oc/po/firmrecalls/roche01_06.html

 

Safety Alert:

 

FDA is alerting the public about three reported cases of serious liver toxicity in patients who took the antibiotic Ketek (telithromycin). The agency has released several recommendations for healthcare providers and their patients who take Ketek which include monitoring for symptoms of liver problems and using the antibiotic only for appropriate infections.

http://www.fda.gov/cder/drug/advisory/telithromycin.htm 

 

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

 

Feb. 8-9 -- FDA Anti-Counterfeit Drug Initiative Public Workshop and Vendor Display

    Under discussion: adoption of radio-frequency identification in the U.S. medicine supply chain to combat counterfeit products

    Location: Bethesda, Md.

http://www.fda.gov/rfidmeeting.html

 

Feb. 8-9 -- Industry Exchange Workshop on FDA Clinical Trial Requirements

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

    Location: Houston, Texas

http://www.fda.gov/OHRMS/DOCKETS/98fr/05-18871.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

 

What changes can I make in my life to help lower my risk of heart disease?

 

Choosing a healthy lifestyle can help you reduce the risk of coronary heart disease or minimize its damage. 

 

Healthy lifestyles include:

  • eating a healthy diet
  • maintaining a healthy weight
  • exercising regularly
  • quitting (or not starting) smoking
  • minimizing stress

For detailed information on each of these, see http://www.fda.gov/hearthealth/lifestyles/lifestyles.html.

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