Procrit, Similar Drugs Linked to Increased Death Risk By Two More StudiesMay 5, 2009 | Parker Waichman LLP
Two more studies have found that anemia drugs like Epogen, Procrit and Aranesp raise the risk of death among cancer patients. Despite known safety risks, drugs like Procrit continue to be used because it is believed that they help reduce the number of blood transfusions some cancer patients need, while improving quality of life. According to a report on MedicineNet.com, these two studies may raise questions about that theory.
Epogen, Procrit and Aranesp are known as erythropoiesis-stimulating agents (ESAs). ESAs are a bioengineered version of a natural protein made in the kidney that stimulates the bone marrow to produce more red blood cells. They are approved in the U.S. to treat anemia in cancer patients undergoing chemotherapy.
ESAs have long been the subject of safety concerns. Last summer, the Food & Drug Administration (FDA) ordered the labeling changes because several studies have shown that Procrit and other ESAs increased tumor growth and shortened survival time in some cancer patients. Among other things, the agency mandated that the labeling be modified to say that the drugs shouldn’t be used in cancer patients receiving chemotherapy when a cure of their cancer is anticipated.
In the first study, researchers from the University of Alberta, Canada, analyzed data from 52 clinical trials that included more than 12,000 people. According to MedicineNet.com, they found that patients treated with ESAs increased the risk of death and serious adverse events such as blood clots by 15% to 16%.
The report, published in the April 30 online edition of the Canadian Medical Association Journal, concluded that ESAs should not routinely be used as an alternative to blood transfusions in patients with anemia related to cancer.
The second study, published in the May 2 issue of The Lancet, was conducted by scientists at the University of Bern in Switzerland. They looked at the findings from 53 cancer trials that included a total of almost 14,000 patients. More than 1,500 patients died during the study period, and almost 5,000 patients died overall, MediciNet.com said. That translated to a 17% increase in deaths during the study period. Patients undergoing chemotherapy had a 10% increased risk of dying.
The authors wrote that the findings "show that erythropoiesis-stimulating agents increase mortality in all patients with cancer, and a similar increase might exist in patients on chemotherapy." They advised that the risks of ESA be balanced against the benefits of treatment. They also said more study is needed to address the drugs' impact on tumor progression and quality of life, MedicineNet.com said.