Takeda Colitis Drug Raises Pml Concern: Fda Staff

Credit: Reuters/Arnd Wiegmann (Reuters) - An experimental drug for ulcerative colitis and Crohn's disease from Takeda Pharmaceutical Co could pose risk of a potentially fatal brain infection called PML even though the problem has not been seen in clinical trials, staff members of the U.S. Food and Drug Administration said on Thursday. Documents about the monoclonal antibody, called Entyvio, were released by the FDA staff ahead of a planned meeting on Monday among a panel of outside medical experts who will review the safety and effectiveness of the medicine and make recommendations to the FDA. Japanese drugmaker Takeda earlier this year filed for marketing approval of Entyvio, whose chemical name is vedolizumab, in the United States and Europe. Some 3,326 patients have received one or more infusions of the medicine in its various clinical trials, with no cases of the brain infection seen, the FDA staff said in a lengthy review document meant to flag potential concerns to the panel of outside medical experts. A larger database of safety information would better enable reviewers to assess the PML risk, the document said. The document expressed concern that PML, formally known as progressive multifocal leukoencephalopathy, has been seen in a drug that works through a similar mechanism: Biogen Idec Inc's Tysabri treatment for multiple sclerosis. The FDA staff noted, however, that Tysabri's risk of causing PML may be partly due to the fact it is often taken over long periods and among patients that have been previously treated with drugs that suppress the immune system. There have been 12 deaths in patients who have received Entyvio, none of which have been linked to the injectable drug, according to the briefing document. The FDA staff questioned whether the benefit of Entyvio outweighs its risks, especially the risk of PML, and whether risk management strategies to prevent PML may be needed if the drug is approved. Crohn's disease and ulcerative colitis are common forms of inflammatory bowel disease, and can cause discomfort, diarrhea, bleeding and other problems. Entyvio is a monoclonal antibody meant to control inflammation by blocking a receptor, or protein, called alpha4beta7 integrin. (Reporting by Ransdell Pierson; Editing by Nick Zieminski) FILED UNDER: find more info http://www.reuters.com/article/2013/12/05/us-takeda-entyvio-fda-idUSBRE9B40Z620131205





Ulcerative Colitis: Symptoms and Treatment



Some people may have periods of remission in which symptoms go away for months and even years, but in most, the symptoms will eventually return. Mild ulcerative colitis symptoms include rectal bleeding, rectal pain or urge for a bowel movement (with no success), bloody diarrhea (from a few occasional episodes to several times a day), abdominal cramps and pain (which usually disappear after a bowel movement), fever, pain that moves to the left side and unintended weight loss. Severe symptoms include bloody diarrhea that becomes severe with abdominal cramps and pain, fatigue and significant weight loss, as well as severe pain, profuse diarrhea, dehydration and shock (rare). You may also experience joint pain, mouth sores, nausea and vomiting , skin lumps or ulcers, or anemia. Preventing Flare-Ups The recurrence of symptoms can be reduced by making some dietary and lifestyle changes. Avoiding certain foods that can worsen diarrhea and gas symptoms is a good start. Try the process of elimination to find out which specific foods aggravate your symptoms. The key is to eat a well-balanced diet to prevent the malnourishment that can result from your intestines not being able to absorb nutrients as well. Eliminating dairy products will only help people who are lactose intolerant. To help control symptoms: --Try eating small meals more frequently --Experiment with fiber - getting more fiber can sometimes help eliminate diarrhea, but may also aggravate your symptoms --Do not eat "gassy" foods, such as beans, cabbage and broccoli --Avoid greasy or fried foods - these can cause more gas and diarrhea because your body might not be able to completely absorb the fat --Drink plenty of fluids to prevent dehydration --Avoid or limit alcohol and caffeine consumption --Consider taking multivitamins to replace lost vitamins and minerals Treatment When flare-ups occur, medical treatment is necessary to control the inflammation that is triggering your symptoms. In more severe cases, when there is massive bleeding, rupture of the colon, risk of cancer or your condition is not responding to medical therapy, you might need surgery. my explanation http://news.yahoo.com/ulcerative-colitis-symptoms-treatment-133714284.html