Anemia drugs are widely used by patients on chemotherapy and patients with chronic kidney disease, but there is growing evidence that the misuse of these drugs is harming many patients. The FDA issued a “safety communication” on June 24, 2011 recommending lower doses of anemia drugs for patients with chronic kidney disease. This warning was based on studies showing increased risk of stroke, blood clots, other cardiac problems, and death for patients with chronic kidney disease. In previous years, FDA had expressed concerns regarding the safety of the same anemia drugs for people undergoing chemotherapy.
These anemia drugs include Procrit, Aranesp, and Epogen, which are multibillion dollar sellers manufactured by Amgen Inc. These drugs were approved by the FDA to treat anemia caused by chemotherapy, chronic kidney condition, and some other illnesses and conditions. Over 20 million Americans have chronic kidney disease.
What is the connection between chronic kidney disease and anemia? People with chronic kidney disease cannot produce red blood cells. When a person’s red blood cell count falls very low, anemia is the result. Procrit, Aransep, and Epogen are Erythopoiesis-Stimulating Agents (ESA), which refers to synthetic versions of a protein that increases the production of red blood cells. By increasing red blood cells, these drugs reduce the need for blood transfusions.
At lower dosages, ESAs are more likely to increase the red blood cell count with less risk of cardiovascular problems. However, even in lower dosages these drugs still pose some risk of stroke, blood clots, and death. For many patients, the benefits of ESAs outweigh the risks, but it often isn’t possible to determine which patients are likely to benefit and which are more at risk. In other words, for many patients, ESAs are a gamble.
The FDA used to recommend that ESAs be used to maintain hemoglobin levels between 10 to 12 g/dL. This goal was removed from the label after studies showed that patients were more likely to die, have a stroke, or experience other serious heart problems when administered ESAs to target a hemoglobin level of more than 11 g/dL.
FDA changed the ESA labels regarding kidney patients so that they now recommend that physicians should “consider starting treatment when the hemoglobin level is less than 10 g/dL.” The label avoids recommending targeted hemoglobin levels and states “this advice does not recommend that the goal is to achieve a hemoglobin of 10 g/dL or a hemoglobin above 10 g/dL.”
The FDA’s goal is to encourage doctors and their patients with chronic kidney disease to “weigh the possible benefits of using ESAs to decrease the need for red blood cell transfusions against the increased risk for serious adverse cardiovascular events.” The FDA recommends that doctors “individualize dosing and use the lowest dose of ESA sufficient to reduce the need for transfusion” instead of setting specific target hemoglobin levels.
The FDA also concludes that ESA drugs do “not improve fatigue, patient well-being, or quality of life.
These concerns regarding ESA for kidney disease patients is similar to previous safety concerns about the safety of Procrit, Aransep, and Epogen for patients who have anemia due to chemotherapy. Seven studies showed that chemotherapy patients taking ESAs tended to die sooner and some even showed an increase in tumor growth. Although the FDA decided to keep ESA approval for chemotherapy patients, the agency issued a drug safety communication in 2010 to recommend a risk management strategy program to improve safety for patients who have anemia due to chronic kidney disease and chemotherapy.
If you are taking any of these drugs because of either chronic kidney disease or chemotherapy, talk to your doctor to see if the benefits of staying on the drug are likely to outweigh the risks. Make sure your doctor is aware of the FDA’s concerns and the research evidence of serious risks. You might consider asking your doctor about going off the drug to see if you are better off without it.
All articles on our website have been approved by Dr. Diana Zuckerman and other senior staff.
References:
The Food and Drug Administration. FDA News Release: FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents. (June 2011) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260670.htm
FDA recommends lower doses of anemia drugs. (2011, June 24). USA Today. http://yourlife.usatoday.com/health/medical/story/2011/06/FDA-recommends-lower-doses-of-anemia-drugs/48815974/1
Centers for Disease Control and Prevention. National Chronic Kidney Disease Fact Sheet: General Information and National Estimates on Chronic Kidney Disease in the United States, 2010. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2010.
FDA recommends lower doses of anemia drugs. (USA Today. 2011, June 24). http://yourlife.usatoday.com/health/medical/story/2011/06/FDA-recommends-lower-doses-of-anemia-drugs/48815974/1
The Food and Drug Administration. FDA News Release: FDA modifies dosing recommendations for Erythropoiesis-Stimulating Agents. (June 2011) http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm260670.htm
The Food and Drug Administration. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythopoiesis Stimulating Agents (ESAs) in chronic kidney disease. (June 2011) http://www.fda.gov/Drugs/DrugSafety/ucm259639.htm
The Food and Drug Administration. FDA Drug Safety Communication: Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp. (February 2010)http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200297.htm