FDA Recommends Modified Dosing of ESAs

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Washington, DCThe 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.

The 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.

According to a recent press release issued by the FDA, more than 20 million people aged 20 years or older in the United States have CKD. Patients with CKD lose the ability to make red blood cells and become anemic. The ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. Drugs in the ESA class are epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp).

In their press release, the FDA states that the use of ESAs can increase the risk for stroke, heart attack, heart failure, blood clots, and death; the ESA Medication Guide (Epogen/Procrit or Aranesp) contains information on the benefits and risks of using these drugs; and that patients should have blood tests while using ESAs. The test results may help guide treatment and lower the risks of using these drugs. A healthcare professional will indicate how often to have blood tests.

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