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FDA Approves Deadly Enbrel Drug for Children

An FDA advisory panel has recommended the approval of Amgen's immune-suppressing drug Enbrel (generic name etanercept) for the treatment of psoriasis in children, in spite of ongoing concerns that the drug may have lethal side effects.The recommendation came only two days after an independent panel recommended that the FDA strengthen Enbrel's label with warnings about potentially fatal side effects such as anemia, seizures, serious infections, cancer or neurological problems. It also comes as the FDA is investigating whether the entire drug family of which Enbrel is a part increases the risk of cancer in children, particularly lymphoma.The FDA is investigating 30 reports of cancer in children and young adults who have been treated with drugs in the family, known as tumor necrosis factor (TNF) blockers. Because TNF blockers interfere with the functioning of the immune system, they are used to treat autoimmune disorders such as Crohn's disease or rheumatoid arthritis. By the same token, however, they can dangerously weaken the body's defenses, exposing it to serious infection or other problems.Enbrel is currently approved for the treatment of rheumatoid arthritis in both adults and children, and for the treatment of moderate to severe psoriasis in adults only. If the FDA follows its panel's recommendation, as it usually does, children with moderate to severe psoriasis will also soon be treated with the drug.One day earlier, the same advisory panel recommended the approval of another adult psoriasis drug: ustekinumab, manufactured by Johnson & Johnson. Only the week before, however, the FDA had issued a warning on its Web site that ustekinumab may increase the risk of cancer in those who take it.People with psoriasis suffer from itchy or painful red, thick patches on the skin. The immune system is believed to play some role in mediating the disease.

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December 2, 2008 at 4:13 AM  

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