New FDA drug labels for anaemia associated with Chronic Kidney Disease patients treated with ESAs

The FDA recommends caution when prescribing drugs that treat Anaemia for patients with Chronic Kidney Disease (CKD) since the drug label's recommendations fall short. The recommendations apply to erythropoiesis-stimulating agents (ESAs) such as Epogen and Procrit (epoetin alfa) and Aranesp (darbepoetin alfa). Trials show that ESAs can increase the risk of heart-related problems such as strokes and heart attacks when used to increase haemoglobin above 13 g/dL. The new ESA label states that clinicians should consider starting ESA treatment when haemoglobin levels fall below 10 g/dL, they should individualise dosing and use the lowest dose of ESA to reduce patients' need for blood transfusions. In addition, if a dialysis patient's haemoglobin level approaches or exceeds 11 g/dL, clinicians should reduce or hold the dose of ESA.