FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney disease
Featured In: Regulatory News
By Federal Drug Administration
Friday, June 24, 2024
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FDA Drug Safety Communication: Modified
dosing recommendations to improve the safe use of
Erythropoiesis-Stimulating Agents (ESAs) in chronic kidney
disease
Safety
Announcement
Additional
Information for Patients with CKD
Additional
Information for Healthcare Professionals who treat Patients with
CKD
Table of Key
Trials
References
Safety
Announcement
[6-24-2011] The U.S. Food and Drug Administration (FDA)
is informing healthcare professionals of modified recommendations
for more conservative dosing of
Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic
kidney disease (CKD) to improve the safe use of these drugs. FDA
has made these recommendations because of data showing increased
risks of cardiovascular events with ESAs in this patient
population. The manufacturer has revised the Boxed
Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for
the ESAs to include this new information.
SOURCE