LYCOS RETRIEVER 
Colitis: Patients
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In September 2004, PDL announced that the FDA had granted Fast Track status to the investigation of visilizumab in patients with IV steroid-refractory ulcerative colitis. Designation as a Fast Track product indicates that the FDA will facilitate the development and expedite the review of a new drug that is intended to treat a serious or life-threatening condition, and that demonstrates the potential to address an unmet medical need. However, Fast Track designation does not mean that the FDA will expedite approval of any application for the product or guarantee approval of the product.
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COLAZAL (balsalazide disodium) Capsules 750 mg is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults has not been established. COLAZAL was well tolerated in clinical studies. In clinical trials, patients reported the following adverse reactions most frequently: headache (8%), abdominal pain (6%), diarrhea (5%), nausea (5%), vomiting (4%), respiratory infection (4%) and arthralgia (4%). Withdrawal from therapy due to adverse reactions was comparable to placebo. For full prescribing information on Salix products, please visit http://www.salix.com/.
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Clostridium difficile associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
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Unlike Crohn's disease, ulcerative colitis can generally be cured by surgical removal of the large intestine. This procedure is necessary in the event of: exsanguinating hemorrhage, frank perforation or documented or strongly suspected carcinoma. Surgery is ... indicated for patients with severe colitis or toxic megacolon. Patients with symptoms that are disabling and do not respond to drugs may wish to consider whether surgery would improve the quality of life.
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Infectious colitis is a colitis of sudden onset in which an identifiable source is often found on culture of the stool. Like the patient with ulcerative colitis a fever may be present, as well as abdominal cramping and pain. Even the colonoscopic appearance may be the same as the patient with ulcerative colitis but more likely it will be normal. However, under the microscope the tissue will usually be different from that of the patient with ulcerative colitis. The course of the patient with an infectious colitis is more favorable than the one of a patient with chronic ulcerative colitis because it will resolve quicker and chronic treatment is generally unnecessary.
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INTRODUCTION — Microscopic colitis is characterized by chronic watery (secretory) diarrhea without bleeding. It usually occurs in middle-aged patients but can affect children. The colon appears normal by colonoscopy or barium enema. The diagnosis is established by biopsy of the colonic mucosa which reveals colitis, but not mucosal ulcerations.
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