The erythropoiesis-stimulating agents (ESAs) epoetin alfa (Epogen, Procrit) and darbepoetin alfa (Aranesp) are widely used for treatment of anemia and to reduce the need for red blood cell transfusions. Based on the results of recent clinical trials indicating an increased risk of serious adverse events and death associated with ESAs, particularly when used to achieve a hemoglobin concentration ≥12 g/dL, the FDA has revised the prescribing information for these drugs to include a black box warning.

Production of erythropoietin, a glycoprotein hormone secreted mainly by the kidney, is often low in patients with chronic renal failure (JW Eschbach, Kidney Int, 35:134, 1989). The US Food and Drug Administration recently approved marketing of epoetin alfa (Epogen - Amgen), a recombinant human erythropoietin, for treatment of anemia in such patients. Epoetin is commercially available in Europe as Eprex (Ortho), and Eprex is available from Ortho in the USA on an investigational basis for treatment of anemia related to AIDS. Epogen and Eprex are chemically...

The FDA has approved daprodustat (Jesduvroq – GSK), a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 4 months. It is the first HIF-PHI and the first oral drug to be approved in the US for this indication.

The FDA has approved the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) vadadustat (Vafseo – Akebia) for oral treatment of anemia due to chronic kidney disease (CKD) in adults who have been on dialysis for at least 3 months. Vadadustat is the second HIF-PHI to be approved in the US for this indication; daprodustat (Jesduvroq) was approved earlier, but it was withdrawn from the US market in 2024 for commercial reasons.

The FDA has approved the erythropoiesis-stimulating agent (ESA) peginesatide (Omontys – Affymax/Takeda), a synthetic peptide analog of erythropoietin, for treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis. Peginesatide is the third ESA to become available in the US.Overuse of the other two, which have broader indications, has been a concern.

Use of epoetin alfa, a recombinant human erythropoietin, is being promoted directly to consumers in vague advertisements that promise renewed energy and improved work capacity. Epoetin is approved by the FDA for treatment of anemia due to chronic renal failure, cancer chemotherapy or HIV treatment, and before elective non-cardiac surgery. It is also used illicitly by competitive athletes to increase their endurance.

Darbepoetin alfa (Aranesp) has been approved by the FDA for treatment of anemia caused by chronic renal disease and will probably also be approved for use in patients with cancer..

With the 2004 Olympics only weeks away, performance-enhancing drugs will once again be receiving a great deal of attention. The US Anti-Doping Agency has published a list of drugs banned in Olympic sports (www.usantidoping.org) that includes, at least for some sports, all but 2 of the drugs reviewed here.

Prosorba, an antibody-adsorbing column used with plasmapheresis, has been approved by the FDA for treatment of moderate-to-severe rheumatoid arthritis in patients refractory or intolerant to methotrexate and other disease-modifying anti-rheumatic drugs (DMARDs).

Midodrine hydrochloride (ProAmatine - Roberts), an alpha1-selective adrenergic agonist, is now available for treatment of severe symptomatic orthostatic hypotension. Other treatments for this condition include other sympathomimetics, constrictive garments, erythropoietin (Epogen; Procrit) and fludrocortisone with salt (D Robertson and TL Davis, Neurology, 45 suppl 5: S26, 1995).