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Adverse Effects, 2nd sentence has been changed from “...hepatic toxicity, sometimes fatal or requiring liver transplantation, has occurred.” to: “...hepatic toxicity that could lead to death or the need for a liver transplantation in some patients has occurred.”
Conclusion, last sentence has been changed from “...leukoencephalopathy, it is FDA-approved for use only in...” to: “...leukoencephalopathy, it should be used only in...”
Natalizumab (Tysabri – Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn’s disease (CD) refractory to conventional therapies and inhibitors of tumor necrosis factor (TNF). Initially approved in 2004 for the treatment of multiple sclerosis (MS), natalizumab was temporarily withdrawn from the market after 3 patients developed progressive multifocal leukoencephalopathy (PML).1 It is now available for treatment of both MS and CD through a restricted distribution program.
TREATMENT OF CROHN’S DISEASE — An amino salicylate such as mesalamine (Asacol, Pentasa), designed to be released only in the distal ileum and colon and/or an antibiotic such as ciprofloxacin (Cipro, and others) or metronidazole (Flagyl, and others) is the usual first-line treatment for mild to moderate active Crohn’s... more