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Aranesp FDA Alerts

The FDA Alert(s) below may be specifically about Aranesp or relate to a group or class of drugs which include Aranesp (darbepoetin alfa).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for darbepoetin alfa

Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations

Jun 24, 2011

Audience: Nephrology, Oncology

Epoetin alfa (marketed as Epogen and Procrit) and darbepoetin alfa (marketed as Aranesp)

ISSUE: FDA notified healthcare professionals that new, modified recommendations for more conservative dosing of Erythropoiesis-Stimulating Agents (ESAs) in patients with chronic kidney disease (CKD) have been approved to improve the safe use of these drugs. FDA has made these recommendations because of data showing increased risks of cardiovascular events with ESAs in this patient population. The new dosing recommendations are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.

BACKGROUND: ESAs treat certain types of anemia by stimulating the bone marrow to produce red blood cells and by decreasing the need for blood transfusions. The manufacturer has revised the Boxed Warning, Warnings and Precautions, and Dosage and Administration sections of the labels for the ESAs to include this new information.

RECOMMENDATION: Healthcare professionals should weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions in CKD patients against the increased risks for serious cardiovascular events, and should inform their patients of the current understanding of potential risks and benefits. Therapy should be individualized to the patient and the lowest possible ESA dose given to reduce the need for transfusions. See the Drug Safety Communication for additional information including a table of key trials and other supporting references. Treatment with ESAs in CKD was discussed at the Cardiovascular and Renal Drugs Advisory Committee, held October 18, 2010. For summary minutes of that Advisory Committee, see link below.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:


[06/24/2011 - Drug Safety Communication - FDA]
[06/24/2011 - Press Release - FDA]
[10/18/2010 - Summary Minutes of the Cardiovascular and Renal Drugs Advisory Committee - FDA]

Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

Feb 16, 2010

Audience: Oncological and nephrological healthcare professionals and patients

FDA and Amgen notified healthcare professionals and patients that all ESAs must be used under a REMS risk management program. As part of the risk management program, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving an ESA. Under the ESA APPRISE Oncology program, Amgen will ensure that only those hospitals and healthcare professionals who have enrolled and completed training in the program will prescribe and dispense ESAs to patients with cancer. Amgen is also required to oversee and monitor the program to ensure that hospitals and healthcare professionals are fully compliant with all aspects of the program. FDA is requiring a REMS because studies show that ESAs can increase the risk of tumor growth and shorten survival in patients with cancer who use these products. Studies also show that ESAs can increase the risk of heart attack, heart failure, stroke or blood clots in patients who use these drugs for other conditions.

[02/16/2010]

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Dec 2, 2008

Audience: Oncologists, other healthcare professionals

[UPDATE 12/02/2008] FDA issued Q&As for recently approved Medication Guides. The Medication Guides were developed to provide patients with important information about the risks of using ESAs. The information in the Medication Guides may affect a patient’s decision to take the drug and it gives patients a starting point for discussion with their healthcare provider about the medical decision to prescribe an ESA.

[UPDATE 08/08/2008] Amgen, Ortho Biotech letter added.

[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

[December 02, 2008 - Q&As on Medication Guides - FDA]
[November 2008 - Medication Guide: Procrit]
[August 07, 2008 - Letter - Amgen, Ortho Biotech]
[July 30, 2008 - Follow Up to Ongoing Safety Review - FDA]

Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

Aug 8, 2008

Audience: Oncologists, other healthcare professionals

[Posted 07/31/2008] FDA informed healthcare professionals of modifications to certain sections of the Boxed Warnings, Indications and Usage, and Dosage and Administration sections of prescribing information for Erythropoiesis Stimulating Agents (ESAs). The changes clarify the FDA-approved conditions for use of ESAs in patients with cancer and revise directions for dosing to state the hemoglobin level at which treatment with an ESA should be initiated. Additional revisions to prescribing information that ESAs are not intended for use in patients receiving myelosuppressive therapy when the expected outcome is cure and when to initiate and discontinue ESA dosing will be forthcoming. FDA continues to encourage healthcare professionals to discuss with their patients before starting or continuing therapy with ESAs, the benefits of treatment with ESAs and the potential and demonstrated risks of ESAs for thrombovascular events, shortened time to tumor progression or recurrence, and shortened survival time.

[August 7, 2008 - Letter - Amgen, Ortho Biotech]
[July 30, 2008 - Follow Up to Ongoing Safety Review - FDA]
[July 30, 2008 - Label - Aranesp]
[July 30, 2008 - Label - Procrit]
[July 30, 2008 - Label - Epogen]

Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Mar 12, 2008

Audience: Oncological healthcare professionals

[Posted 03/12/2008] Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.

[March 07, 2008 - Dear Healthcare Professional Letter - Amgen]

Erythropoiesis Stimulating Agents:Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)

Nov 8, 2007

Audience: Oncologists, nephrologists, other healthcare professionals

[Posted 11/08/2007] FDA notified healthcare professionals of revised boxed warnings and other safety-related product labeling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anemia. These new statements address the risks that the drugs Aranesp, Epogen, and Procrit pose to patients with cancer and patients with chronic kidney failure. For patients with cancer, the new boxed warnings emphasize that ESAs caused tumor growth and shortened survival in patients with advanced breast, head and neck, lymphoid and non-small cell lung cancer when they received a dose that attempted to achieve a hemoglobin level of 12 grams per deciliter (g/dL) or greater. For patients with chronic kidney failure, the new boxed warning states that ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk of death and other serious conditions. The new labeling provides specific instructions for dosage adjustments and hemoglobin monitoring for chronic kidney failure patients who do not respond to ESA treatment with an adequate increase in their hemoglobin levels.

Additionally, the new boxed warnings clarify that ESAs should only be used in patients with cancer when treating anemia specifically caused by chemotherapy and not for other causes of anemia. Further, it states that ESAs should be discontinued once the patient's chemotherapy course has been completed.

[November 08, 2007 - News Release - FDA]

Aranesp (darbepoetin alfa) - Mar 9, 2007

Mar 9, 2007

Audience: Oncologists, nephrologists, other healthcare professionals

[UPDATE 03/09/2007] 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.

[Posted 02/16/2007] FDA notified healthcare professionals of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

Erythropoiesis Stimulating Agents

Feb 16, 2007

Audience: Oncologists, nephrologists, other healthcare professionals

[UPDATE 03/09/2007] 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.

[Posted 02/16/2007] FDA notified healthcare professionals of the results from a large clinical trial evaluating use of an erythropoiesis-stimulating agent (ESA) to treat anemia in cancer patients not receiving chemotherapy. In this study, patients received either Aranesp, an ESA, according to the approved dosing regimen or placebo. Patients treated with Aranesp had a higher death rate and no reduction in the need for transfusions compared to those treated with placebo. The findings in the Aranesp study may apply to other ESAs. Additionally, the findings show that treating anemic cancer patients not currently on chemotherapy with an ESA may offer no benefit and may cause serious harm.

Aranesp (darbepoetin alfa) - Jan 27, 2007

Jan 27, 2007

Audience: Oncological healthcare professionals

[Posted 01/27/2007] Amgen notified the oncology medical community of the results of a large, multicenter, randomized, placebo-controlled study showing that Aranesp was ineffective in reducing red blood cell transfusions or fatigue in patients with cancer who have anemia that is not due to concurrent chemotherapy. The study also showed higher mortality in patients receiving Aranesp. Aranesp is approved for the treatment of patients with anemia caused by the chemotherapy treatment of the malignant disease and should only be used in accordance with its approved product labeling.

[January 26, 2007 – Letter – Amgen]

Aranesp

Dec 1, 2005

Audience: Hematology/Oncology, Nephrology and other healthcare professionals

[Posted 12/01/2005] Amgen and FDA notified healthcare professionals of revision to the WARNINGS, ADVERSE REACTIONS, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Aranesp. The revised labeling provides updated safety information on reports of pure red cell aplasia and severe anemia, with or without other cytopenias, associated with neutralizing antibodies to erythropoietin in patients treated with Aranesp. This has been reported predominantly in patients with CRF receiving Aranesp by subcutaneous administration. Recommendations for evaluation and treatment are provided in the new prescribing information.

[November 2005 - Aranesp Letter - Amgen]
[October 2005 - Aranesp Label - Amgen]

Aranesp (darbepoetin alfa) - Jan 14, 2005

Jan 14, 2005

Audience: Oncologists, hematologists and other healthcare professionals

FDA and Amgen notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Aranesp, indicated for the treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies. This safety information alerts physicians to the adverse effects observed with other products in this class in association with off-label dosing strategies. Two recent investigational studies with other erythropoietic products permitted or required dosing to achieve hemoglobin levels of greater than 12 grams per deciliter. An increased frequency of adverse patient outcomes, including increased mortality and thrombotic vascular events were reported in these studies. As indicated in the Aranesp prescribing information, the target hemoglobin level should not exceed 12 grams per deciliter in men or women.

[January 11, 2005 - Letter - Amgen]
[December 16, 2004 - Label - Amgen]

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