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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
  • 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
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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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