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Spontaneous Reports of Natalizumab-associated Liver Injury Adverse Event Reporting System (AERS)

Spontaneous Reports of Natalizumab-associated Liver Injury Adverse Event Reporting System (AERS). 28 recently identified unduplicated cases (reported 11/04 - 6/22/07) 4 cases of potentially serious hepatocellular injury; 3/4 cases in US

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Spontaneous Reports of Natalizumab-associated Liver Injury Adverse Event Reporting System (AERS)

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  1. Spontaneous Reports of Natalizumab-associated Liver InjuryAdverse Event Reporting System (AERS) • 28 recently identified unduplicated cases (reported 11/04 - 6/22/07) • 4 cases of potentially serious hepatocellular injury; 3/4 cases in US • Remaining 24 reports of mild liver abnormalities e.g. “increased liver enzymes,” “increased LFTs” • No deaths or liver transplants • Liver injury ‘signal’ not identified in clinical trials

  2. Cases of Potentially Serious Natalizumab associated Liver Injury (n = 4) • Liver injury occurred within 18 days after 1st dose in 3/4 cases; after 5 doses in 1/4 cases • Range of peak serum ALT: 521 u/L - 2,427 u/L* • Range of peak serum total bilirubin: Normal – 15.7 mg/dLtt • Diagnostic workups did not identify another obvious cause of liver injury • Further evaluation of cases is in progress * upper limit of normal: 44 u/l tt upper limit of normal: 1 mg/dL

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