FDA Public Health Advisory
On Friday, March 9, 2007, the U.S. Food and Drug Administration (FDA) updated the instructions and warnings for the use of the drugs Epogen® (EPO), Procrit® and Aranesp®. These are all drugs used to treat anemia, a common symptom of kidney failure.
Why has this happened?
Recently, several studies have been published regarding the use of anemia medications. These studies focused primarily in the oncology (cancer) and pre-ESRD (pre-end stage renal disease or non-dialysis patient populations). The FDA made the changes to the medications' labels after reviewing the findings from these studies.
What does all of this mean?
As a result, the FDA is changing its advice to your doctor regarding recommended hemoglobin levels.
Does this mean I’ve been getting too much EPO?
Not necessarily. Your physician has written a prescription for you taking into consideration your health needs, the results of your monthly lab draws and all of the relevant scientific studies. The dose of EPO that you receive should be a decision between you and your doctor, based on your own individual medical situation.
Does this mean I should stop taking EPO?
No. Only your physician should make that type of decision. Untreated anemia can lead to fatigue and other more serious conditions that can make dialysis more difficult.
What is DaVita’s position?
Your safety, health and well-being are our primary concern. DaVita centers have achieved the best overall clinical outcomes in the industry. We are proud of the fact that we have the highest patient survival rates in the United States.
DaVita has partnered with the leading physicians in the country and will ensure that your physician has access to these experts as they evaluate the new FDA recommendations.
Who should I talk to if I have additional questions?
You should talk with your doctor. DaVita health care professionals at your center will be glad to help arrange this call.
More information
- DaVita press release: DaVita Will Study New FDA Eythropoiesis-Stimulating Agents Label
- FDA website:FDA Public Health Advisory
- New York Times:F.D.A. Warning Is Issued on Anemia Drugs’ Overuse
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