No new safety concerns were identified in T72, the FDA says. Existing safety issues with infliximab and other tumor necrosis factor inhibitors include fungal infections and lymphoma. In April, the FDA requested labeling changes to notify users about the risk of hepatosplenic T-Cell lymphoma (HSTCL).
HSTCL has occurred mostly in adolescent or young adult males treated with infliximab and concomitant azathioprine or 6-mercaptopurine. It is therefore especially important, the FDA says, to consider this safety data when making treatment decisions involving children.
In its briefing material, Centocor notes that it has an extensive education program to inform users and physicians about the drug’s risk. Its safety in treating pediatric patients with inflammatory bowel disease, including UC, is being assessed in two ongoing prospective registries.
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