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The US Food and Drug Adminstration has issued a Public Health Advisory outlining new safety information for the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa (Aranesp®) and epoetin alfa (Epogen®, Procrit®). This follows recently reported safety concerns that have arisen from results of various clinical trials involving these products. The advisory highlights what patients being treated with ESAs should be told, the main important study results, and advice for prescribers, as follows:
• Adjust the dose of ESA to maintain the lowest haemoglobin level necessary to avoid the need for transfusions.
• Monitor patients’ haemoglobin levels to ensure they do not exceed 12g/dl.
• Understand that ESAs are given to decrease the chances of receiving transfusions.
• Understand that ESAs have not been shown to improve outcomes of chemotherapy treatment (e.g. better tumour shrinkage, delay in tumour growth or longer time for survival).
• Consider both the risks of transfusions and those of ESAs when deciding to prescribe an ESA.
• Understand that ESAs should not be given to treat symptoms of anaemia, including shortness of breath, dizziness, fatigue, low energy, or poor quality of life.
FDA Medwatch stresses that the research studies were evaluating either an unapproved dosing regimen (target haemoglobin levels above that currently approved), a patient population for which ESAs are not approved, and/or a new unapproved ESA. The FDA believes these safety concerns apply to all ESAs and is re-evaluating how to safely use this product class. FDA and Amgen, the manufacturer of Aranesp, Epogen and Procrit, have amended the full US prescribing information for these drugs to include new warnings and a change to the dosage and administration sections.
National Electronic Library for Medicines 12/03/2007
