FDA News -- FDA News Digest for May 27, 2008

FDA News Digest

May 27, 2008

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IN THIS WEEK'S ISSUE

» News

-- Drug Approved to Help Restore Bowel Function After Surgery

» Safety Alerts/Recalls

» Upcoming Public Meetings

» Consumer Health Information

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NEWS

Drug Approved to Help Restore Bowel Function After Surgery

FDA has approved Entereg (alvimopan) to accelerate the restoration of normal bowel function in patients 18 years and older who have undergone partial large- or small-bowel resection surgery. Entereg will be used in hospitalized patients who can receive no more than 15 doses. FDA approved Entereg with a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks. The REMS will include limits on dispensing of the drug.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01838.html

To view an archive of recent 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

Safety Alerts:

FDA is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01839.html

FDA has requested that Miami-based SEI Pharmaceuticals recall all Xiadafil VIP Tabs sold in 8-tablet bottles (Lot # 6K029) or blister cards of 2 tablets (Lot # 6K029-SEI) because these products contain a potentially harmful, undeclared ingredient that may dangerously affect blood pressure and can cause other life-threatening side effects. These lots of Xiadafil VIP Tabs bear an expiration date of September 2009 (09/09). Xiadafil VIP Tabs are marketed as a dietary supplement for sexual enhancement and to treat erectile dysfunction.

http://www.fda.gov/bbs/topics/NEWS/2008/NEW01840.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

May 29 -- Dermatologic and Ophthalmic Drugs Advisory Committee

Under discussion: pending application for new drug proposed to treat inflammation and pain following eye surgery

Location: Rockville, Md.

http://edocket.access.gpo.gov/2008/E8-8351.htm

May 30 -- Science Board to FDA

Under discussion: keeping pace with scientific and technical evolutions in regulatory science

Location: Gaithersburg, Md.

http://edocket.access.gpo.gov/2008/E8-10257.htm

May 30 -- Oncologic Drugs Advisory Committee

Under discussion: pending application for a new drug treatment to increase platelet counts and reduce or prevent bleeding in certain patients

Location: Chicago

http://edocket.access.gpo.gov/2008/E8-10258.htm

For a complete list of upcoming meetings, seminars, and other public events sponsored

or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html.

CONSUMER HEALTH INFORMATION

This week's spotlight consumer updates are:

› Controlling Cholesterol with Statins

http://www.fda.gov/consumer/updates/statins051608.html

› Start at the Store: 7 Ways to Prevent Foodborne Illness

http://www.fda.gov/consumer/updates/foodillness051308.htm

To receive all consumer updates by e-mail, go to http://www.fda.gov/consumer/consumerenews.html.

For the latest in consumer health news from FDA, visit http://www.fda.gov/consumer/default.htm.

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