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FDA recommends more conservative dosing of ESAs in chronic kidney disease
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New, modified recommendations for more conservative dosing of erythropoiesis-stimulating agents in patients with chronic kidney disease have been approved by the FDA to improve the safe use of these drugs, according to an agency press release. The new recommendations are based on data demonstrating an increased risk for cardiovascular events with erythropoiesis-stimulating agents in these patients.
According to the press release, the new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of >11 g/dL in patients with chronic kidney disease provides no additional benefit than lower target levels, and increases the risk for serious adverse cardiovascular events, such as heart attack or stroke.
The boxed warning, warnings and precautions, and dosage and administration sections of the labels have been modified by the manufacturers to include this new information.
Healthcare professionals should weigh the possible benefits and risks associated with ESA treatment in these populations, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions, according to the FDA.
The Drug Safety Communication includes additional information, including a table of key trials and other supporting references. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of ESAs to the FDA’s MedWatch Safety Information and Adverse Reporting Program.
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