FDA Wants Warning Label Strengthened on Anemia Drugs

Shannon Weidemann

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Amgen Inc. and Johnson & Johnson sell and market two very popular injectible anemia medicines. The FDA advisory panel has voted that Aranesp and Epogen, also known as Procrit, should have stronger warning labels.

ESAs are approved to treat chemotherapy-induced anemia and chronic kidney disease-related anemia. The agency committee was meeting to reassess the risks of using of ESAs in the cancer setting. Another agency committee will meet to discuss the safety profile of the drugs in relation to kidney patients in early fall, Riley said.
The panel also recommended that the drugs' labels should specifically state that ESAs aren't indicated for use in specific tumor types in which clinical studies have revealed safety concerns, but only after additional studies are conducted, said Riley. Specific tumor types weren't targeted.
Further, labels should define hemoglobin levels in asymptomatic patients; they should also recommend that the use of ESAs should be discontinued after a chemotherapy regimen is completed and the degree of anemia with a subsequent chemo regimen is re-evaluated, the panel recommended.

The panel's findings are non-binding but the FDA tends to follow them. The drugs are part of the class of erythropoiesis-stimulating agents (ESAs) that stimulate the body into producing more red blood cells to combat anemia.