Home : Unsafe Drugs : Epogen : FDA Information : Public Health Advisory: Recombinant Human Erythropoietins (marketed as Procrit, Epogen, and Aranesp)

Public Health Advisory: Recombinant Human Erythropoietins (marketed as Procrit, Epogen, and Aranesp)

FDA Public Health Advisory
Epoetin alfa (marketed as Procrit, Epogen)
Darbepoetin alfa (marketed as Aranesp)

This is no longer current information. The FDA has new information about this safety issue at http://www.fda.gov/cder/drug/infopage/RHE/default.htm.

Today, The New England Journal of Medicine published the results of a research study about Procrit, an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin. The study found a higher chance of the combination of death, heart attack, hospitalizations for heart failure and stroke in patients with chronic kidney disease who are not on dialysis and were treated with Procrit to raise their hemoglobin levels higher than what the labeling for the product recommends. Procrit, like the other ESAs Epogen, and Aranesp, increases blood hemoglobin levels, the oxygen carrying component of blood, by increasing the number of red blood cells in the body.  These products are used to treat anemia in certain patients.

The maximum treatment level recommended in product labeling for all approved ESAs is to raise blood hemoglobin levels to no higher than 12 g/dL. The results of this latest study emphasize the importance of following this recommendation.

In light of this research study, FDA is advising the following:

  • To reduce serious complications from the use of ESAs, healthcare professionals should be familiar with the recommendations in the product labeling to maintain hemoglobin levels between 10 to 12 g/dL.
  • Frequent tests to monitor blood hemoglobin levels are an important component of an ongoing ESA treatment plan.  Healthcare professionals should talk with their patients about the importance of keeping appointments for simple blood tests to monitor hemoglobin levels.
  • Patients should contact their doctor if they feel any worsening in shortness of breath, pain or the swelling in the legs or increases in blood pressure.

The New England Journal of Medicine article, published on November 16, 2006, presented the results of the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study.  The CHOIR study evaluated the potential benefit and harm from treatment with Procrit in patients with chronic kidney disease who are not on dialysis.  In the study, harm was defined as a group of effects that included death, heart attack, hospitalizations for heart failure and stroke.  The research found that patients in the study who were treated with Procrit to raise their blood hemoglobin concentration to the higher 13.5 g/dL level experienced more death and life-threatening harm than those who were treated to raise their blood hemoglobin concentration to the lower 11.3 g/dL level.   

The FDA is working to fully evaluate the CHOIR study data and to determine if any additional actions are necessary in order to optimize the use of erythropoiesis-stimulating agents.  FDA plans to notify healthcare providers and patients as additional information becomes available.

The FDA urges both healthcare providers and patients to report adverse events to MedWatch.  MedWatch reports may be made by phone: 1-800-FDA-1088; fax: 1-800-FDA-0178; or via the Internet at http://www.fda.gov/medwatch/index.html

 

Need An Epogen Attorney?

First Name Last Name Email Address State
Was Your Health Negatively Affected?

Please Describe the Injury

Your Friend's Email Address

Your Email Address

Type a Message (optional)


Looking for a Washington, DC Epogen attorney? Get in touch with one of our Washington, DC Epogen attorneys now.

 

Close (x)

Looking for an Attorney?


Please type your question:

Close (x)

logo Find Legal Help for Your Epogen Case - Submit Your Information Below

Do you need legal assistance with your Epogen case?
LegalView may be able to help.


Submit your information below for a free, no-cost evaluation.

We'll submit your information to one of our partner firms.
LegalView's partners represent clients throughout the United States, for a very wide range of legal issues. Submit your information now, to see if one of LegalView's partners can help!

* Indicates Required Fields

First name *
Last name *
Email Address *
Phone Number *
()  -

State *
Legal Issue * Unsafe Drugs: Epogen Change
Was There an Injury?
Please Describe The Injury

DISCLAIMER and STATEMENT OF NON-CONFIDENTIALITY

By submitting this form, you agree that completing the above is not intended to create an attorney-client relationship.

Disclosure

Legal WebTV Network LLC, LegalView.com, and LegalWebMedia.com are group advertising sponsored by the attorneys identified here. It is not a lawyer referral service. If you submit information on this website [more...]

Legal WebTV Network LLC, LegalView.com, and LegalWebMedia.com are group advertising sponsored by the attorneys identified here. It is not a lawyer referral service. If you submit information on this website, LegalWebMedia.com will submit your information to the law firms that pay for this group advertising and to respond to your requests for information concerning legal services in their assigned local areas. If there is no sponsoring firm in your state, your inquiry will be submitted to one of the sponsoring law firms on a predetermined, rotating basis. If the sponsoring law firm accepts your case, it will associate with licensed attorneys practicing in your state, if required; the sponsoring law firm may also contact other law firms to see if they may be able to assist.

The information provided by the LegalView.com and LegalWebMedia.com websites is for advertising and informational purposes and should not be considered as legal advice from the sponsoring attorneys. The websites contain general information and may not reflect current legal developments, verdicts, or settlements. LegalView.com contains information created by others or supplied through open forums; the sponsoring law firms are not responsible for the accuracy of this information. Any person viewing or receiving information from these websites should not act or refrain from acting on the basis of any such information without first seeking appropriate legal advice from an attorney in your area. Legal WebTV Network, LLC expressly disclaims any liability with respect to actions taken or not taken by the recipient based on any or all of the information or contents contained in these websites.

Any information sent to Legal WebTV Network LLC through this website is done using standard Web encryption techology. LegalView.com will exercise all reasonable care, within technological limits, to protect the confidentiality of any information submitted via Internet e-mail or through this website. By accessing this website, you may be seeking an attorney to represent you or legal advice. However, none of the sponsoring attorneys represent you yet.

The choice of a lawyer is an important decision and should not be based solely upon advertisements.

Any transmission of information, whether via Internet e-mail or through the website, is solely for evaluation purposes by the sponsoring law firms and their associates. The transmission of any information to any attorney sponsoring advertising on LegalView.com or LegalWebMedia.com does not create an attorney-client relationship between the sender and any recipient. An attorney-client relationship can only be created by a written, signed-fee agreement entered into with an attorney. The sponsoring attorneys will treat your information as a confidential communication for the purpose of obtaining legal services or legal advice.

For more information about the sponsoring law firms, please click here.
This form is secure and encrypted. More information about secure forms and your privacy here.