FDA places dose limits on anemia drugs

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The FDA has modified recommendations for erythropoiesis-stimulating agents (ESAs) after the agency found clinical evidence that the drug class could increase cardiovascular event risk in chronic kidney disease patients. The FDA has recommended that more conservative doses of the drug be administered.

The drug class is indicated to treat certain types of anemia by stimulating bone marrow to produce red blood cells and decreasing the need for blood transfusions. The drugs involved are epoetin alfa (marketed as Epogen and Procrit, Amgen and Janssen Biotech) and darbepoetin alfa (marketed as Aranesp, Amgen). 

The use of ESAs to target a hemoglobin level greater than 11 g/dL increases the risk of adverse cardiovascular events and has not been shown to provide additional patient benefit. “No clinical trial to date has identified a hemoglobin target level, ESA dose or dosing strategy that does not increases these risks,” the FDA noted.

The agency has recommended that healthcare providers weigh the benefits of using the drug class against the increased risk of CV events. In addition, the agency said that physicians should individualize doses of the drug and administers them in the lowest possible ESA dose to reduce the need for transfusions.

For chronic kidney disease patients not on dialysis, the agency recommends that providers consider initiating ESA treatment only when hemoglobin levels are less than 10 g/dL. If the hemoglobin level exceeds 10 g/dL, the agency suggests that providers reduce or interrupt the dose of ESA and use the lowest dose that can still sufficiently reduce the need for red blood cell transfusions.

The FDA has said that the drug manufacturer has revised the boxed warning, warnings and precautions and dosage and administration sections of these ESA drugs. The agency said that it will continue to evaluate the safety of ESAs and will require drug manufacturers to conduct additional trials.

Providers and patients should report all adverse events to FDA's MedWatch program.