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FDA Drug Safety Podcasts
Transcript [music] On March 9, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Interferon gamma-1b (marketed as Actimmune). I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research. On March 5, 2007, InterMune, the maker of Actimmune, reported the early stopping of the INSPIRE study of Actimmune for treating idiopathic pulmonary fibrosis, or I-P-F. The study was stopped because an interim analysis showed that patients with I-P-F who received Actimmune did not benefit. The trial compared survival in patients getting Actimmune or an inactive injection, called a placebo. An analysis showed that 14 point 5 percent of patients treated with Actimmune died as compared to 12 point 7 percent of patients treated with placebo. Actimmune is not approved by us to treat I-P-F. Actimmune is a synthetic version of Interferon gamma-1b, a naturally occurring biologic response modifier. We have approved Actimmune to decrease the number and severity of infections in patients with chronic granulomatous disease and to delay the progression of severe, malignant osteopetrosis. I-P-F is a chronic progressive lung disease of unknown cause in which the lungs are scarred. Patients with I-P-F can have severe and disabling shortness of breath. The disease usually progresses and patients frequently die from respiratory failure. There are no drugs proven to be effective for treating I-P-F. We are making the following three recommendations:
We will evaluate the INSPIRE study results. If the review reveals additional important information to share, we will notify health-care providers and patients. More details can be found in our Information for Healthcare Professionals by following the links at F-D-A dot gov slash C-D-E-R. We are asking health-care professionals to report serious adverse events in connection with Actimmune to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot gov slash MedWatch. Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R. [music] Additional Information
Date created: March 13, 2007 |
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