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FDA Medwatch Alert: Actimmune (Interferon Gamma 1-b)

Posted 9 Mar 2007 by

[Posted 03/09/2007] FDA notified healthcare professionals of the early termination of the INSPIRE clinical study of Actimmune for idiopathic pulmonary fibrosis (IPF). The study was stopped because an interim analysis showed that patients with IPF who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection (placebo). An analysis showed that 14.5% of patients treated with Actimmune died as compared to 12.7% of patients treated with placebo. Actimmune is not approved by the FDA to treat IPF.   [March 09, 2007 - Public Health Advisory - FDA][March 09, 2007 - Drug Information Page - FDA] Read more

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Idiopathic Pulmonary Fibrosis, Cutaneous T-cell Lymphoma, Chronic Granulomatous Disease, Osteopetrosis

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