PharmExec Blog

FDA Strengthens Warnings on TNF Inhibitors

On Tuesday, FDA announced that makers of tumor necrosis factor (TNF) blockers must change their labels to include boxed warnings for “increased risk of lymphoma and other malignancies in children and adolescents.” That’s in addition to the current box warning that the drugs might lead to cancer. TNF blockers (or inhibitors) are used to reduce inflammation brought on by a number of diseases, including Chrohn’s disease, asthma, and rheumatoid arthritis.

The warning comes after two separate analyses of lymphoma and leukemia in children and teens being treated with TNF blockers such as Enbrel, Remicade, and Humira. Last year, FDA requested that all TNF blocker manufacturers submit lists of all cancer-related cases in which children were being treated with such medications.

Of the 48 cases submitted, about half the children had different versions of lymphoma; 11 died from the disease. In the leukemia study, the feds reviewed 147 cases of patients on TNF blockers. Thirty of those patients died, 26 from leukemia associated with TNF blockers.

In both cases, the patients were being treated with other medications, and linking the cause of death to TNF blockers is difficult. However, FDA feels there’s enough information to warrant a warning that taking these treatments could boost risk of leukemia or lymphoma.

“Additional data are expected from the ongoing long term, observational, postmarketing studies and registries that are being conducted by the TNF blocker manufacturers,” FDA stated in a release. “In addition, FDA is working with TNF blocker manufacturers to explore new ways to further define the risk of malignancy in children and adolescents using TNF blockers.”

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One Comment

  1. natalia
    Posted August 6, 2009 at 6:21 pm | Permalink

    what about the adults that are in treatment with remicade or other TNF alfa blockers? had they made some analysis of the adults with rheumatoid arthritis, behcet disease, etc and receiving this treatment?

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