FDA News Digest for September 17, 2007

[FDA News Digest <fdanewsdigest@xxxxxxxxxx>]

FDA News Digest

September 17, 2007

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IN THIS WEEK'S ISSUE

 

»  News

    --  Evista Now Approved to Reduce Breast Cancer Risk in Postmenopausal Women

    --  Study of 500,000 Aims to Determine If ADHD Drugs Pose Possible Heart Risks

    --  FDA Licenses 15 New Blood Typing Tests to Help Ensure Safe Transfusions

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

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NEWS

 

Evista Now Approved to Reduce Breast Cancer Risk in Postmenopausal Women

FDA has approved Evista (raloxifene hydrochloride) for reducing the risk of invasive breast cancer in postmenopausal women with osteoporosis or at a high risk of invasive breast cancer. Evista was approved in 1997 for osteoporosis prevention in postmenopausal women and in 1999 for treating postmenopausal women who have osteoporosis.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01698.html

 

Study of 500,000 Aims to Determine If ADHD Drugs Pose Possible Heart Risks

FDA and the Agency for Healthcare Research and Quality are collaborating on the most comprehensive study to date of prescription medicines used to treat attention deficit hyperactivity disorder (ADHD) and their potential for increased risk of heart attack, stroke, or other cardiovascular problems. The study will examine the clinical data of about 500,000 children and adults who have taken ADHD drugs.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01700.html 

 

FDA Licenses 15 New Blood Typing Tests to Help Ensure Safe Transfusions

FDA has licensed 15 new blood typing tests that have been previously unavailable in the United States. The tests are used to determine the blood type of blood donors, a critical step in ensuring safe blood transfusions.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01699.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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SAFETY ALERTS/RECALLS

Medical Device Recall:

 

›  Normal Saline Flush syringes with lot numbers ending in "SFR"

    Reason for recall: customer complaints about particles in the saline

http://www.fda.gov/oc/po/firmrecalls/braun09_07.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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UPCOMING PUBLIC MEETINGS

Sept. 19-20 -- FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee

    Under discussion: pending application for a product to reduce adhesion formation in patients undergoing cardiac surgery (Sept. 19) and clinical trial designs for cardiac ablation devices designed to treat patients with medically unresponsive atrial fibrillation (Sept. 20)

    Location: Gaithersburg, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-14600.htm

 

Sept. 24-28 -- Parenteral Drug Association/FDA Joint Regulatory Conference (including exhibition and training courses)

    Conference title: "Evolution of the Global Regulatory Environment: A Practical Approach to Change"

    Location: Washington, D.C.

http://www.pda.org/webmodules/webarticles/templates/new_conferences_2007pdafda.aspx?articleid=923&zoneid=149 

 

Oct. 1 -- Interagency Working Group on Import Safety

    Under discussion: key challenges/actions for industry, consumers, and governments to ensure the safety of imported products

    Location: Washington, D.C.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-17305.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

 

FDA's Web site features a page with information for consumers. Each week in FDA News Digest, we will spotlight material from that page by offering links to timely articles about FDA activities and products the agency regulates.

 

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

 

›  The Skinny on Liposuction

http://www.fda.gov/consumer/updates/liposuction082007.html

›  6 Tips to Avoid Medication Mistakes

http://www.fda.gov/consumer/updates/medtips062107.html

›  Coping with Memory Loss

http://www.fda.gov/consumer/features/memoryloss0507.html

 

FDA also has created a free monthly e-newsletter for consumers that contains information posted on the 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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