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NEW WARNING
Biogen Idec and Elan has issued a "Dear Healthcare Professional" letter about updates to prescribing information for their integrin receptor antagonist natalizumab (Tysabri). Post-marketing studies have shown incidence of severe liver injury in patients treated with natalizumab. Signs of liver injury included markedly elevated liver enzymes and total bilirubin levels. The new prescribing information includes warnings about hepatotoxicity, including severe liver damage that may lead to death or the need for a liver transplant. They suggest discontinuation of treatment in patients with elevation of liver enzymes or signs and symptoms of significant liver injury (jaundice, liver tenderness and enlargement, nausea, dark urine). Patients should be advised to report these symptoms immediately.
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