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FDA Scientists Seek Another Infection Warning for Enbrel

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Food & Drug Administration (FDA) scientists are concerned about Enbrel’s link to fatal infections in kids, and have recommended stronger warnings for the medication. Their findings also make it less likely that the agency will approve the Amgen and Wyeth drug to treat severe psoriasis in children. Enbrel is already approved to treat psoriasis and rheumatoid arthritis in adults and juvenile arthritis in children, and an FDA advisory panel is set to consider expanding its approved uses to include severe psoriasis in children on Wednesday.

Enbrel is made from a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance made by the body’s immune system called TNF. Today, FDA scientists expressed concern about broadening the drug’s approval, citing reports of dangerous side effects in children who have already taken the drug. Reports submitted to the agency linked to infections that sometimes led to hospitalization and death. Of the 14 deaths recorded by the FDA, more than half were in children taking Enbrel for arthritis, while the others were among children taking the drug for unapproved uses. The FDA scientists also recommended that stronger warnings about the possibly-fatal infections be added to Enbrel’s label.

In April, the FDA had Amgen and Wyeth include a new black box warning on the Enbrel label stating that the drug has been associated with serious infections, including tuberculosis in some patients. The new Enbrel black box warning was prompted by global studies of over 20,000 patients taking Enbrel, where tuberculosis was observed in about 200 people.

The FDA is also reviewing Enbrel and other TNF blockers over a possible link to cancer. The FDA is investigating about 30 reports of leukemia, lymphoma and other cancers in children and young adults submitted between 1998, after the approval of the first TNF blocker, through April of this year. Approximately half of the reports were lymphomas, cancer of the immune system cells, that were both Hodgkin’s and non-Hodgkin’s based.

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