FDA News Digest & Recalls for April 28, 2008

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FDA News Digest April 28, 2008 ___ IN THIS WEEK'S ISSUE » News -- Drug Approved to Treat Bowel Disorder Crohn's Disease -- Glove Made from New Type of Latex Cleared for Marketing -- New Regulation Strengthens Safeguards for Beef Consumers -- Relistor Approved to Treat Opioid-Induced Constipation -- Pet Food Maker Ordered to Obtain Emergency Operating Permit » Testimony » Safety Alerts/Recalls » Upcoming Public Meetings » Consumer Health Information ________ NEWS Drug Approved to Treat Bowel Disorder Crohn's Disease FDA has approved Cimzia (certolizumab pegol) to help sufferers of moderate-to-severe Crohn's disease who have not responded to conventional therapies. Crohn's disease is a chronic, inflammatory bowel disorder that affects more than 1 million men and women worldwide. It has no cure and its cause is unknown. Patients treated with Cimzia will receive an injection every two weeks for the first three injections. Once benefit has been established, Cimzia should be given once every four weeks. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html Glove Made from New Type of Latex Cleared for Marketing FDA has cleared for marketing the Yulex Patient Examination Glove, the first device made from guayule latex, a new form of natural rubber latex. Traditional latex gloves contain a protein that may trigger allergic reactions, especially after prolonged and repeated contact. Estimates vary, but anywhere from 3 percent to 22 percent of all health care workers are sensitized to traditional latex. Available data on the new guayule latex show that even people who are highly allergic to traditional latex do not react on first exposure to guayule latex proteins. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01822.html New Regulation Strengthens Safeguards for Beef Consumers FDA has issued a final regulation barring certain cattle materials from all animal feed, including pet food. The rule further protects animals and consumers against bovine spongiform encephalopathy (BSE, also known as "mad cow disease"). The new measure builds on FDA's 1997 feed regulation, which prohibited the use of certain mammalian proteins in ruminant feed. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01823.html Relistor Approved to Treat Opioid-Induced Constipation FDA has approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain. Such patients include those with a diagnosis of incurable cancer, end-stage chronic obstructive pulmonary disease from emphysema, heart failure, Alzheimer’s disease with dementia, HIV/AIDS or other advanced illnesses. Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from functioning. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01826.html Pet Food Maker Ordered to Obtain Emergency Operating Permit FDA has issued an order requiring that Illinois-based Evanger's Dog & Cat Food Co. Inc. obtain an emergency permit from FDA before its canned pet food products enter interstate commerce. A recent inspection revealed significant deviations from prescribed documentation, which could result in underprocessed pet foods that can allow the survival and growth of Clostridium botulinum, a bacterium that causes botulism in some animals as well as in humans. For Evanger's to resume business, the company must document that corrective actions and processing procedures have been implemented to ensure that the finished product will not present a health hazard. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01825.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.] ___________ TESTIMONY April 25 -- FDA Office of Food Safety Deputy Director Don Kraemer appeared before the U.S.-China Economic and Security Review Commission Hearing on "Chinese Seafood: Safety and Trade Issues" http://www.fda.gov/ola/2008/seafood042408.html April 24 -- FDA Center for Food Safety and Applied Nutrition Director Stephen F. Sundlof, DVM, appeared before the House Subcommittee on Health. "Food and Cosmetic Provisions of the 'Food and Drug Administration Globalization Act' Discussion Draft Legislation" http://www.fda.gov/ola/2008/fdaglobalact042408.html April 22 -- FDA Commissioner Andrew C. von Eschenbach, M.D., appeared before the House Subcommittee on Oversight and Investigations "FDA Actions to Improve Safety of Medical Products with Foreign Components" http://www.fda.gov/ola/2008/foreigninspection042208.html To view an archive of past testimony by FDA officials, go to http://www.fda.gov/ola/listing.html _ SAFETY ALERTS/RECALLS Drug Recall: › Bertek and UDL label Digitek (digoxin tablets, USP, all strengths) for oral use Reason for recall: tablets may contain twice the approved level of active ingredient http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html Food Recall: › Silk Soymilk Chocolate Flavor, 11-ounce plastic single serve bottles printed with both a "use by" date of May 7, 2008 (printed as 05 07 08) and a Universal Product Code (UPC) of 2529360028 Reason for recall: product may contain milk protein not declared on label http://www.fda.gov/oc/po/firmrecalls/whitewave04_08.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 April 24-25 -- Ophthalmic Devices Panel of the Medical Devices Advisory Committee Under discussion: pending application to market an implantable miniature telescope Location: Gaithersburg, Md. http://edocket.access.gpo.gov/2008/E8-5810.htm April 29-30 -- Public Workshop on Safety of Hemoglobin-Based Oxygen Carriers Location: Bethesda, Md. http://www.fda.gov/cber/meetings/hboc042908.htm May 1-2 -- Blood Products Advisory Committee Under discussion: several topics, including 2007 West Nile Virus Epidemiology Location: Rockville, Md. http://edocket.access.gpo.gov/2008/E8-6208.htm For a complete list of meetings, seminars, and other public events sponsored or co-sponsored by FDA, go to http://www.fda.gov/opacom/hpmeetings.html. CONSUMER HEALTH INFORMATION Improved Consumer Page Debuts FDA‘s main consumer page features a new graphic look. It also offers a greatly expanded selection of Consumer Updates containing timely information you can use. From drug safety to food labels to pet turtles, the page contains hundreds of easy-to-ready articles, all of which are now searchable by title, topic or date. Check it out at http://www.fda.gov/consumer/default.htm This week's spotlight articles are: › Use Eye Cosmetics Safely http://www.fda.gov/consumer/updates/eyecosmetics041708.html › Salmonella Illnesses May be Linked to Recalled Cereal http://www.fda.gov/consumer/updates/cereal041408.html To receive all consumer updates, go to http://www.fda.gov/consumer/consumerenews.html Thanks for subscribing to FDA News Digest. Our next issue will be sent May 5. Comments about FDA News Digest? Send an e-mail to fdanewsdigestv. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). 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