New warnings added to ESA labels yet again

November 13, 2007

FDA adds new warnings to erythropoiesis-stimulating agents' labels.

For the fifth time since their first approval in 1989, erythropoiesis-stimulating agents' (ESAs) labels have been updated to include new safety information. According to the FDA, the recommendation to include the new information came from two agency advisory committee meetings held earlier this year, and it expands upon labeling changes made in March. The modifications include a hemoglobin (Hb) target range of 10-12 gm/dl for chronic kidney failure patients with anemia and an upper limit of 12 gm/dl for patients with cancer who have anemia caused by chemotherapy. In addition, ESAs should be discontinued in cancer patients once the chemotherapy course has been completed. The boxed warning for ESAs will now include a list of cancers for which a Hb level of 12 gm/dl or greater resulted in shorter survival time and/or time-to-tumor progression. The agency will now require ESA manufacturers to make changes to the Indication section of the PI that emphasizes the fact that there are no data to support claims of improvement of anemia symptoms. Information has also been added on managing patients who are poor responders to ESA therapy. The FDA said it is working with the companies to design and conduct clinical trials that look at different dosing regimens and tumor types to further characterize tumor progression. Distribution of an FDA-approved Medication Guide will now be required for each patient prior to administration of the drugs. In related news, Procrit maker, Ortho Biotech, said it will request that CMS reevaluate its final National Coverage Determination (NCD) for ESAs by providing new scientific information. The company believes that CMS misinterpreted existing data in reaching its current NCD.

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