Tag Archives: ESA

FDA Approves Risk Management Plan for ESAs

Cancer patients will learn more from their doctors about the possible risks and benefits of erythropoiesis-stimulating agents (ESAs) to manage anemia during chemotherapy under a new program just approved by the FDA. ESAs can be given to chemotherapy patients to reduce the need for blood transfusions.  However, there can be problems with ESAs including causing some tumors to grow faster or some patients to die sooner.  They can also increase risk for blood clots, heart failure, heart attack or stroke. ESAs, including Procrit®, Epogen®, and Aranesp®, are now covered by a REMS or Risk Evaluation and Mitigation Strategy which requires that patient receive a Medication Guide from their health care

ESAs Increase Blood Clot Risk

Drugs to treat anemia in older cancer patients increased their risk of blood clots and didn’t reduce the need for blood transfusions. Among over 56,000 cancer patients 65 and older treated in community settings from 1991 through 2002, 27 percent received an erythropoiesis-stimulating agent (ESA).   Fifteen percent of those who got ESAs developed a blood clot (venous thromboembolism) compared to 10 percent of patients who didn’t have ESA treatment. Although the goal of ESAs was to reduce the need for blood transfusions, the percentage of transfusions remained steady at 22 percent each year from 1991 through 2002.  Overall survival didn’t differ between the patients who received ESAs and those who

FDA Releases Questions and Answers about ESA Medication Guides

The Food and Drug Administration now provides answers to questions about using erythropoiesis-stimulating agents (ESAs) and their FDA-approved Medication Guides.  The Medication Guides are now part of labeling for ESAs Aranesp® (darbepoetin alfa), Epogen® (epoetin alfa), and Procrit® (epoetin alfa). The Guides are designed to help patients make informed decisions about the risks and benefits of using ESAs and to give them a starting point for discussions with their doctors.  The Medication Guide must be given to directly patients or their caregivers at the time an ESA is dispensed.

Amgen Changes Pricing Policy for Aranesp

As of October 1, 2008 Amgen will no longer offer rebates to oncologists and oncology clinics who purchase Aranesp® (darbepoetin alfa) although they will provide larger discounts at the time of purchase. They also will no longer base discounts for Neulasta® (pegfilgrastim) and Neupogen© (filgrastim) on purchases of Aranesp, a process known as bundling.  Neulasta and Neupogen help raise white cell counts lowered by chemotherapy and are designed to prevent infection resulting from treatment. Nancy Roach, Chairperson of the C3: Colorectal Cancer Coalition, told the New York Times, It’s a step in the right direction. In addition, she told C3 Research News that C3 supports fair pricing policies for drugs

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