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FDA Drug Safety Podcasts
Transcript [music] Welcome to the Food and Drug Administration's drug safety update. I am Pat Clarke from F-D-A's Center for Drug Evaluation and Research. On March 9, 2007, we issued a public health advisory recommending that patients with idiopathic pulmonary fibrosis who are taking Actimmune, also known at Interferon gamma-1b, should discuss with their doctors whether they should continue this treatment. Our recommendation follows an announcement by the maker of Actimmune that a clinical study of the drug to treat the condition had been stopped early. An interim analysis showed that patients receiving Actimmune to treat idiopathic pulmonary fibrosis did not benefit. 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. To hear the full public health advisory, listen to part 2 of this broadcast. 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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