Medication Adverse Event Alert
March 13, 2007
| MEDICATION: | Erythropoiesis Stimulating Agents, Epoetin alfa (marketed as Procrit®, Epogen®), Darbepoetin alfa (marketed as Aranesp®)* *(See also RxAmerica, LLC, Medication Event Alerts on EPO dated 11/17/06 & 1/29/07) |
| ISSUE: | New boxed warning, updated warnings, and change to package insert |
| MANUFACTURERS: | Amgen (Epogen, Aranesp), Ortho Biotech (markets and distributes Procrit) |
The following FDA Alert was released on March 9, 2007:
"FDA notified healthcare professionals of new safety information for erythropoiesis-stimulating agents (ESAs) Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa). Four new studies in patients with cancer found a higher chance of serious and life-threatening side effects or death with the use of ESAs. These research studies were evaluating an unapproved dosing regimen, a patient population for which ESAs are not approved, or a new unapproved ESA. FDA believes these new 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 changed the full prescribing information for these drugs to include a new boxed warning, updated warnings, and a change to the dosage and administration sections for all ESAs."
An excerpt of the "FDA Public Health Advisory" dated March 9, 2007 concerning this alert is provide below:
"Patients currently using or considering the use of an ESA should know the following:
A higher chance of death and an increased rate of tumor growth were reported in patients with advanced head and neck cancer receiving radiation therapy and in patients with metastatic breast cancer receiving chemotherapy, when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
A higher chance of death was reported and no fewer blood transfusions were received when ESAs were given to patients with cancer and anemia not receiving chemotherapy.
A higher chance of death was reported and an increased number of blood clots, strokes, heart failure, and heart attacks were reported in patients with chronic kidney failure when ESAs were given to maintain hemoglobin levels of more than 12 g/dL.
A higher chance of blood clots was reported in patients who were scheduled for major surgery and given ESAs.
ESAs are not approved for treatment of the symptoms of anemia, such as fatigue in patients with cancer, surgical patients and patients with HIV.
If you have any questions you should talk with your health care provider.
Physicians who prescribe ESAs should:
Adjust the dose of ESA to maintain the lowest hemoglobin level necessary to avoid the need for transfusions.
Monitor patients' hemoglobin levels to ensure they do not exceed 12 g/dL.
Understand that ESAs are given to decrease the chances of receiving transfusions.
Understand that ESAs have not been shown to improve the outcomes of chemotherapy treatment (e.g., better tumor shrinkage, delay in tumor 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 the symptoms of anemia, including shortness of breath, dizziness, fatigue, low energy, or poor quality of life."
