JEDDAH, 5 June 2007 — Three drugs used to treat anemia — Aranesp, Epogen and Procrit — have been linked to serious complications in cancer and kidney patients, the Saudi Food & Drug Authority (SFDA) said in a warning notice.
The drugs, erythropoiesis stimulating agents (ESAs), are approved to treat anemia in patients with chronic kidney failure and in cancer patients. Epogen and Procrit are used for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia in HIV patients.
Aranesp, Epogen and Procrit are genetically engineered versions of a natural protein, erythropoietin, which increases the number of red blood cells.
The warning of the Saudi authority against the use of Procrit, Aranesp and Epogen came after reports that some patients had suffered heart attacks and strokes after using the drugs. The SFDA called upon the public to inform the Health Ministry and the manufacturing company about side effects after using the drugs.
The US Food and Drug Administration (FDA) recently issued an alert informing medical professionals and the public about cases of severe anemia and pure red cell aplasia (PRCA) in patients taking ESAs.
On March 9, the FDA announced new warning labels for the drugs, citing an increased risk of blood clots, heart attacks and even death in kidney patients when the drugs are taken at higher than recommended doses.
Patients with brain and throat cancers have noticed faster tumor growth when the medications were given in high doses. At recommended doses, there was an increased risk of death for cancer patients who were not receiving chemotherapy. There was also an increased risk of blood clots in people who had orthopedic surgery.
The new warning label advises doctors to monitor patients’ levels of red blood cells and to use the lowest possible dose to avoid the need for blood transfusions. Additionally, the FDA advises both doctors and patients to carefully weigh the risks and benefits of a transfusion if anemia worsens.
