28 aveil 2008
FDA Articles
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
