ESAFacts.org

Information for Physicians and Patients

U.S. Food and Drug Administration (FDA)

The latest information from the FDA is available here:
http://www.fda.gov/cder/drug/infopage/RHE/default.htm

ESA SAFETY

Press Release on Risks of Anemia Drugs issued by the FDA on January 3, 2008 is available here: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01769.html

Information for patients issued by the FDA on November 11, 2007 is available here: http://www.fda.gov/cder/foi/label/2007/103234s5158ppi.pdf

The FDA approved labels for ESA products are here:

For Aranesp : http://www.fda.gov/cder/foi/label/2007/103951s5164lbl.pdf

For Epogen/Procrit : http://www.fda.gov/cder/foi/label/2007/103234s5158lbl.pdf

On May 10, 2007 the FDA’s Oncologic Drugs Advisory Committee (ODAC) met to consider old and new information on the safety and efficacy of ESA products used by patients with cancer. The information prepared by both the drug sponsor, Amgen, Inc., and the FDA can be seen at this link:

http://www.fda.gov/ohrms/dockets/ac/07/slides/2007-4301s2-00-index.htm

The Summary Minutes for the May 10, 2007 ODAC meeting are here:

http://www.fda.gov/ohrms/dockets/ac/07/minutes/2007-4301m2.pdf

The full transcript of the May 10, 2007 ODAC meeting can be found here:

http://www.fda.gov/ohrms/dockets/ac/cder07.htm#OncologicDrugs

Points to consider as you review documents on the FDA website:

1. The drug sponsor, Amgen, and the FDA do not agree on interpretation of some of the same clinical data, in part because different statistical methods of analysis are used.

2. Note that Table 1 in the new ESA labels lists the median achieved hemoglobin levels in certain clinical trials that demonstrated reduced survival or shorter time to tumor progression. In two of three studies, the achieved median hemoglobin concentration was less than 12 g/dL.

BLOOD TRANSFUSION SAFETY

On February 6, 2008 the FDA issued an Adverse Determination Letter to the American Red Cross. This letter includes notification of a fine of $4,649,000 and documents numerous incidents of failure to comply with safety commitments described in the Consent Decree established between the US Government and the American Red Cross in 2003. The full text of the letter from the FDA, with the attachments, is available at this link: http://www.fda.gov/ora/frequent/letters/ARC_20080206_AD_letter.pdf