Wednesday, March 21, 2007

Black Box Warnings for Procrit, Eopgen and Aranesp

From several sources:

Last week the the FDA issued a warning that using of an erythropoiesis-stimulating agent (ESA) also known as recombinant human erythropoietin to raise hemoglobin may be linked to serious and life-threatening side-effects or even death.

What is particularly noteworthy is that the FDA has stated there has never been any evidence to support claims made in direct-to-consumer advertising that treatment with darbepoetin (Aranesp), epoetin alfa (Epogen), or epoetin alfa (Procrit) might increase energy or ease fatigue in patients that face cancer therapy.

What does the warning say?

That persons taking any of the stated drugs use 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 red blood cell transfusions had a higher incidence of deep vein thrombosis. Aranesp is not approved for this indication.
For more, go here.