 | Advisory on Treating IPF with Actimmune (May 2007) FDA is alerting healthcare professionals that early results of a clinical study have indicated that patients with idiopathic pulmonary fibrosis (IPF) did not show a survival benefit from being treated with Actimmune, a synthetic version of interferon gamma-1b. Actimmune is not approved to treat IPF. InterMune, the maker of Actimmune, has stopped the study because an interim analysis showed that mortality in IPF patients treated with the drug was 14.5% compared to 12.7% in patients receiving placebo. Reported side effects of treatment included constitutional symptoms, neutropenia, and possibly pneumonia. Although Actimmune has not been approved to treat IPF, some IPF patients may be receiving this product off-label. Healthcare providers should discuss the results of this trial with IPF patients on Actimmune and should carefully consider whether to continue treatment with the drug. FDA is evaluating the study results and will notify healthcare providers if the review reveals additional important information. Additional Information: FDA MedWatch Safety Alert. Actimmune (Interferon Gamma 1-b). March 12, 2007. http://www.fda.gov/medwatch/safety/2007/safety07.htm#Actimmune |
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