FDA Warns Again Of Rare Cancer Associated With TNF Blockers
FDA is asking for an additional round of label changes for the tumor necrosis factor inhibitor class, as a consequence of mounting evidence of cases of a rare and usually fatal type of lymphoma in patients taking the drugs.
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Manufacturers must conduct in-depth follow-up of reported malignancies in children and young adult patients and submit them to FDA within 15 days of learning about the cases.
Agency accepts 8-week efficacy, but says long-term data is sparse for the tumor necrosis factor inhibitor, which goes before the Gastrointestinal Drugs Advisory Committee July 21.
Risks of cancer and fungal infections are likely to grab a great deal of attention from the Gastrointestinal Drugs Advisory Committee when it reviews Centocor Ortho Biotech's Remicade (infliximab) for children July 21.