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Natalizumab for Crohn's Disease
The Food and Drug Administration has approved natalizumab (Tysabri) for treating moderate to severe Crohn's disease in patients who have inflammation and who either don't respond to or don't tolerate conventional Crohn's treatments
However, Tysabri has serious risks, including progressive multifocal leukoencephalopathy, a viral brain infection. It also may raise the risk of anaphylaxis and liver injury. Common adverse effects include headache, fatigue, infusion reaction, urinary tract infection, joint and limb pain, and rash.
Tysabri's risks are serious enough that officials require patients to be enrolled in the restricted-distribution Crohn's Disease–Tysabri Outreach Unified Commitment to Health (CD TOUCH) program and that the drug be given by trained staff at certified infusion centers.
Because of the risk for serious infection, Tysabri shouldn't be combined with immunosuppressants. Also, patients taking steroids should start tapering them when Tysabri therapy starts. Tysabri should be stopped at 3 months if the patient shows no improvement or at 6 months if concurrent steroid therapy can't be fully tapered by then.
Crohn's disease is an incurable chronic inflammatory bowel disease that can cause abdominal pain and cramping, diarrhea, fever, rectal bleeding, malnutrition, and intestinal narrowing, abscesses, obstruction, and fistulas. Natalizumab was approved in June 2006 for treating relapsing multiple sclerosis.
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