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Advisory on Treating IPF with Actimmune
Posted on April 29, 2008
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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Firm of the Month
April 2008 - Personal Injury California
Stanton T. Mathews & Associates
has built its practice on representing and fighting for the rights of accident victims in Laguna Hills, California and the surrounding Counties of Central Orange, Los Angeles, San Diego, Riverside and San Bernardino. With over 64 years of combined personal injury legal experience; the personal injury lawyers at Stanton T. Mathews & Associates have the experience and ability to provide personal injury/accident legal solutions to the residents of Laguna Hills, California and throughout the entire State of California.
