Caroline Novas, Cancer Prevention and Treatment Fund
Anemia drugs are widely used by patients undergoing 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.1
Procrit, Aransep, and Epogen are Erythopoiesis-Stimulating Agents (ESAs), 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.
The latest FDA “communication” again raises concerns about the safety of these drugs for any use, including patients with anemia due to chemotherapy. Studies show that cancer patients who receive ESAs have worse outcomes than patients who do not, because of higher mortality rates as well as faster cancer progression. In addition, evidence presented at a 2008 FDA meeting showed that only one in three cancer patients benefit from taking ESAs.2 The FDA requires this information on the labels for these drugs, but they continue to be widely used.
Procrit, Aranesp, and Epogen are multibillion dollar sellers manufactured by Amgen Inc.3 These drugs were approved by the FDA to treat anemia caused by chronic kidney condition in 1989 and chemotherapy in 1993.4
What is the connection between chemotherapy and anemia? Chemotherapy eliminates cancer cells but also attack healthy red blood cells. When a person’s red blood cell count falls very low, anemia is the result.3 In fact, seven out of ten chemotherapy patients develop anemia.5
In 2007, the FDA required warning labels for ESAs to treat patients with cancer and chronic kidney disease. The labels emphasize the risk of tumor growth and shortened survival when prescribed at a high dosage. Additionally, the warning label states that “symptoms of anemia, fatigue, and quality of life have not been shown to improve in patients with cancer who are treated by ESAs.”6
In 2010, the FDA finally responded to the studies showing increased tumor growth and shortened survival time. Although the FDA did not take the drugs off the market, they did issue a drug safety recommendation to recommend a risk management strategy program to improve safety for patients who have anemia due to chronic kidney disease and chemotherapy. Oncologists treating cancer patients must now undergo training before prescribing the drug. It also required that patients sign a written acknowledgment stating that the doctor has explained the risk of taking the drug.2
Given the FDA statement that ESA drugs do “not improve fatigue, patient well-being, or quality of life” and that the drugs only benefit one in three cancer patients,2 why does the agency allow cancer patients to continue taking the drug? They do so because there is no doubt that ESAs can reduce the need for blood transfusions. In addition, some patients respond very well to the drugs, and do not experience the side effects of increased tumor growth.7 As a result, for many patients the benefits of reduced blood transfusions outweigh the risks of tumor growth and increased mortality rates. The problem is that 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.
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 latest 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.
1The 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
3FDA recommends lower doses of anemia drugs. USA Today. June 6, 2011. http://yourlife.usatoday.com/health/medical/story/2011/06/FDA-recommends-lower-doses-of-anemia-drugs/48815974/1
4Centers 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.
5Patient Advocate Foundation. Chemotherapy-Related Anemia Guide. http://www.patientadvocate.org/help.php?p=194
6The Food and Drug Administration. News Release: FDA Strengthens Boxed Warnings, Approves Other Safety Labeling Changes for Erythropoiesis-Stimulating Agents (ESAs). November 8, 2007. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm109024.htm
7The Food and Drug Administration. Questions and Answers for Erythropoiesis-stimulating Agents (ESAs) Labeling Changes. November 8, 2007. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm110280.htm