FDA News Digest for January 22, 2008

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA News Digest for January 22, 2008

 

FDA News Digest

January 22, 2008

_____________________________________

IN THIS WEEK'S ISSUE

 

»  News

    -- Test Cleared That Detects Four Respiratory Viruses

    -- New HIV Drug Approved; Used in Combination With Others

    -- Two Products Approved to Help Control Surgical Bleeding

    -- Label Change for Birth Control Patch Includes Clot Risk Info

    --  OTC Cough, Cold Product Recommendations Released 

»  Safety Alerts/Recalls

»  Upcoming Public Meetings

»  Consumer Health Information

__________________________________________

NEWS

 

Test Cleared That Detects Four Respiratory Viruses

FDA has cleared for marketing the ProFlu+, a test that simultaneously detects four common respiratory viruses -- including the flu -- in a patient’s respiratory secretions. The test provides results in as few as three hours. Other diagnostic tests for respiratory viruses are fast but not as accurate or are accurate but not as rapid.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01780.html

 

New HIV Drug Approved; Used in Combination With Others

FDA has approved etravirine tablets for treating HIV infection in adults who have failed treatment with other similar drugs. Etravirine helps block an enzyme HIV needs to multiply. The drug was approved for use in combination with other anti-HIV medications. It is sold under the trade name Intelence.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01783.html

 

Two Products Approved to Help Control Surgical Bleeding

›  FDA has expanded its approval for Evicel, a liquid sealant, to cover bleeding control during general surgery. Evicel is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01777.html

›  FDA has approved Recothrom, the first blood-clotting solution made using a genetic modification process called recombinant DNA. The product can help stop small blood vessels from bleeding after surgery.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01779.html

 

Label Change for Birth Control Patch Includes Clot Risk Info

FDA has approved additional changes to the Ortho Evra Contraceptive Transdermal (skin) Patch label to include findings that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills.The patch was studied in women aged 15-44, and these recent findings support an earlier study that also said women in this group were at higher risk for blood clots.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html

 

OTC Cough, Cold Product Recommendations Released 

FDA is recommending that over-the-counter (OTC) cough and cold products not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur from such use. These products include decongestants, expectorants, antihistamines, and antitussives (cough suppressants). 

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01778.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.]

___________________________________________

 

SAFETY ALERTS/RECALLS

 

Food Recalls:

 

›  The New Era Canning Co. is expanding its product recall because of potential Clostridium botulinum contamination to all canned green beans and garbanzo beans distributed by the company nationwide over the last five years. C. botulinum can cause botulism, a serious and sometimes life-threatening condition. The affected cans are large-sized containers for institutional use, weighing approximately six and a half pounds.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01782.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.]

 

__________________________________________________________________

 

UPCOMING PUBLIC MEETINGS

 

Jan. 23 -- Gastrointestinal Drugs Advisory Committee

    Under discussion: pending application for a new post-surgery drug

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-23177.htm

 

Feb. 1 -- Drug Safety and Risk Management Advisory Committee

    Under discussion: pending application for a new drug to treat iron deficiency anemia

    Location: Silver Spring, Md.

http://www.fda.gov/OHRMS/DOCKETS/98fr/E7-24003.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 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:

 

›  Animal Cloning and Food Safety

http://www.fda.gov/consumer/updates/cloning011508.html

›  Facts About Crohn’s Disease

http://www.fda.gov/consumer/updates/crohnsdisease011508.html

 

If you would like to sign up to receive all consumer updates, go to

http://www.fda.gov/consumer/consumerenews.html  

 

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

 

 

Thanks for subscribing to FDA News Digest.

Our next issue will be sent January 28.

 

Comments about FDA News Digest?

Send an e-mail to fdanewsdigest@xxxxxxxxxv.

 

---

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420