Aranesp, Epogen, & Procrit Lawsuit Claims

Aranesp, Epogen, and Procrit -- three common drugs used to treat anemia -- have been linked to serious complications in cancer and kidney patients. The drugs, which are erythropoiesis stimulating agents (ESAs), have been approved to treat anemia in patients with chronic kidney failure and in cancer patients whose anemia is caused by chemotherapy. 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 FDA recently issued an alert informing medical professionals and patients about cases of severe anemia and pure red cell aplasia (PRCA) in patients taking ESAs. This news infers that Erythropoietin drugs are actually making patients worse rather than better.

PRCA is a condition in which the body's white blood cells begin to attack its own bone marrow --bone marrow is necessary in the creation of new healthy blood cells. Anemia is a deficiency in which the body produces less red blood cells/hemoglobin. Anemia can be brought on by excessive blood loss, red blood cell destruction, or red blood cell production deficient.

The FDA Announcements

On June 24, 2011, the FDA issued a warning that more conservative dosing guidelines should be used for erythropoiesis-stimulating agents (ESAs) when they are used to treat anemia in patients with chronic kidney disease because of an increased risk of cardiovascular events, including stroke, thrombosis and death. These recommendations are to be added to the Boxed Warning on the label and were announced after clinical trials showed an increased risk of cardiovascular events when ESAs are used to bring blood hemoglobin to normal or nearly normal levels. FDA also noted that ESAs have not been proven to improve quality of life, fatigue or patient well-being.

The new label will now urge patients and physicians to carefully weigh the benefits of using ESAs to lessen the need for red blood cell transfusions against the risk of serious cardiovascular events. Dosing should be done on an individual basis and the lowest dose possible of ESAs are to be given.

On March 9, 2007 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 head and neck cancers developed tumor growth faster when given the higher doses. When the drugs were given at recommended doses, there was an increased risk of death in people with cancer 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. This new information pertains to all ESAs and the FDA is currently re-evaluating the safe use of ESA.

All three drugs are manufactured by Amgen Inc. Procrit is marketed and distributed by Ortho Biotech LP, a subsidiary of Johnson & Johnson. A representative from Amgen said the medications have well-established safety profiles in millions of cancer and kidney patients who were given the drugs according to the FDA's dosing guidelines. However, safety concerns were discussed during a 2004 meeting of the Oncologic Drugs Advisory Committee. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.

The Epogen website warns patients of a study in which patients with kidney failure and cardiac disease taking Epogen showed an increase rate of thrombotic events and fatalities. The company also warns that Epogen should be discontinued in patients with antibody-mediated anemia.

Amgen sales totaled over $5 billion in sales last year. Ortho Biotech's Procrit (erythropoietin) has seen a decline in sales as consumers report negative side effects. Side effects reported include fluid retention/swelling, headaches, high blood pressure, nausea, and fatigue.

Aransep, Epogen, and Procrit Legal Help

If you or a loved one has suffered negative side effects from Aransep, Epogen, Procrit, or other anemia drugs, you may qualify for damages or remedies that may be awarded in a possible class action lawsuit. Please click the link below to submit your complaint to a lawyer who will review your claim at no cost or obligation.

Last updated on Jul-5-11