FDA Issues Communication Communication about an Ongoing Safety Review of ESAs
Communication about an Ongoing Safety Review
Erythropoiesis-Stimulating Agents (ESAs) Epoetin alfa (marketed as Procrit, Epogen) Darbepoetin alfa (marketed as Aranesp)
This information
reflects FDA’s current analysis of available data concerning
these drugs.FDA intends to update this document when additional
information or analyses become available.
ROCKVILLE, Md., Jan. 3, 2008--On November 8, 2007, FDA approved new labeling strengthening the Boxed Warning and Warnings sections of the labeling for Epogen/Procrit and Aranesp and summarizing the results of six studies showing decreased survival and/or tumor progression in patients with cancer receiving an ESA. This communication provides you with the findings from two additional clinical studies (PREPARE and GOG-191 studies) showing an increase in mortality and shorter time to tumor progression in patients with cancer receiving an ESA. This new information further underscores the safety concerns regarding the use of ESAs in patients with cancer addressed in previous communications.
On November 30, 2007, Amgen, Inc., the manufacturer of Epogen and Procrit (Epoetin alfa) and Aranesp (Darbepoetin alfa) notified FDA of findings from a study in patients with primary breast cancer receiving chemotherapy prior to surgery and randomly assigned to a group that was to receive Aranesp or no Aranesp. This study, PREPARE (Preoperative Epirubicin Paclitaxel Aranesp Study), was a multicenter, clinical study conducted in Germany that enrolled 733 patients with primary breast cancer.
On December 4, 2007, Amgen, Inc., notified FDA of the findings of study GOG-191 (National Cancer Institute Gynecologic Oncology Group), a study in which 109 of a planned 460 patients with cervical cancer treated with chemotherapy and radiation were randomly assigned to a group that was either to receive an ESA or transfusions. The GOG-191 study stopped enrolling patients because of a higher rate of potentially life-threatening blood clots occurring in the patients who received an ESA.
Both the PREPARE study in breast cancer and the GOG-191 study in cervical cancer showed higher rates of death and or tumor progression in patients who received an ESA compared to patients who did not receive an ESA.
FDA is currently reviewing this information and will take additional actions as appropriate. FDA will hold another public advisory committee meeting in early 2008 to reevaluate the risk and benefit balance of ESAs for the treatment of patients with chemotherapy-induced anemia. In the interim, healthcare professionals should consider the risks of tumor progression and decreased survival observed when ESAs are used as supportive care in patients with cancer. These risks should be carefully weighed against the need for and potential risks of red cell blood transfusions.
FDA strongly recommends that healthcare professionals discuss the risks of ESA-associated tumor progression and shortened survival with their patients before starting or continuing ESA therapy.
ESAs should be used in patients with cancer only to treat the anemia caused by chemotherapy and not other causes of anemia. The use of ESAs should be stopped after the patient's planned chemotherapy course is completed.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA will work with the manufacturer of Epogen, Procrit and Aranesp to fully evaluate the risks and benefits associated with the use of ESAs in patients with cancer. As soon as this process is complete, FDA will communicate the conclusions and recommendations to the public.
The FDA urges healthcare professionals to promptly report serious and unexpected adverse reactions associated with Epogen, Procrit and Aranesp to the FDA MedWatch reporting program, as described below.
- online at www.fda.gov/medwatch/report.htm
- by returning the postage-paid FDA form 3500 (available in PDF format at www.fda.gov/medwatch/getforms.htm) to 5600 Fishers Lane, Rockville, MD 20852-9787
- faxing the form to 1-800-FDA-0178
- by phone at 1-800-332-1088
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