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Amgen Inc. and Johnson & Johnson anemia drugs will carry strong new warnings after studies showed a higher risk of death and life-threatening side effects in some patients.
The Quick Facts on Aransep Black Box Warning
The FDA warned today that aggressive use of erythropoiesis-stimulating agents to raise hemoglobin to a target of 12 g/dL or higher was associated with "serious and life-threatening side-effects and or/death."
Aranesp is Amgen's best-selling drug, with sales of about $4.1 billion in 2006.
The agency ordered a black-box warning for the drugs that recommended the lowest possible dose to slowly raise the hemoglobin concentration to the lowest level that will avoid the need for a blood transfusion.
The FDA approved Aranesp on September 17, 2001. Tthe U.S. Food and Drug Administration (FDA) approved Aranesp (darbepoetin alfa) for treatment of anemia associated with chronic renal failure.
The Food and Drug Administration said a "black box warning," the strongest type possible for prescription drugs , will encourage doctors to use the lowest doses possible to avoid the need for blood transfusions.
FDA Warning Includes:
- Avoid serious cardiovascular and arterial and venous thromboembolic events by using the lowest dose of Aranesp, Epogen, or Procrit that will gradually raise the hemoglobin concentration to the lowest level sufficient to avoid the need for blood transfusion
- Aranesp, Epogen, and Procrit and other erythropoiesis-stimulating agents increased the risk for death and for serious cardiovascular events when dosed to achieve a target a hemoglobin of greater than 12 g/dL.
- Use of erythropoiesis-stimulating agents to achieve a target hemoglobin of 12 g/dL or greater in cancer patients shortened the time to tumor progression in patients with advanced head and neck cancer receiving radiation therapy; shortened overall survival and increased deaths attributed to disease progression in patients with metastatic breast cancer receiving chemotherapy; and increased the risk of death in patients with active malignant disease not under treatment with chemotherapy or radiation therapy. Erythropoiesis-stimulating agents are not indicated for this patient population.
- Patients treated before surgery with epoetin alfa to reduce allogenic red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication
Recent reports of studies with erythropoiesis-stimulating agents (ESAs) have shown a higher chance of serious and life-threatening side effects and greater number of deaths in patients treated with these agents," an FDA public health advisory said.
On January 14, 2005 Amgen and the FDA sent letters to doctors advising them of a revision to the warning label for Aranesp.
If you have been injured by the prescription drug Aranesp and have suffered any side effects, please contact our experienced Aranesp lawyers now for a free case evaluation.
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