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Recombinant-DNA drug Enbrel, made by Amgen, is apparently worrying the U.S. Food and Drug Administration reviewers which allege there might be life-threatening side effects associated with the drug's use in children. Enbrel is based on the substance etanercept, a fusion protein which links human soluble TNF receptor to the Fc component of human immunoglobulin G1 (IgG1).
The drug was initially developed by biotechnology company Immunex and is used in the treatment of immune disorders such as psoriasis and arthritis. However, it appears that it causes infections and cancers in some children. The problem is that plaque psoriasis in children is hardly a serious health problem, it is more of an aesthetic problem.
This means that using immunosuppressants such as Enbrel, which are bound to have systemic widespread side effects, as they interfere with the way in which the immune system works, may not be warranted in children. Exposing them to risks of death or serious infections may be something that a doctor shouldn't do.
However, there's big money in the drug as millions are affected by the disease. Amgen, which acquired Immunex and the drug, will not give up easily, although the FDA will most likely delay or prevent approval of its use in children.
Aside from the panel's recommendation that the drug should be used in children with psoriasis only in severe cases, it also recommends that the label is changed to inform of the health risks, changing the current wording which says there might be "mild" side effects in children treated for arthritis.
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