O'Connor Law

The FDA last week added black box warnings to the $10 billion a year anemia drugs Procrit, Epogen and Aransep, citing an increased risk of death, stroke, heart attack and blood clots. The strong new warnings were added after studies showed a higher risk of death and
life-threatening side effects in some patients.

These drugs are genetically engineered versions of a natural protein, erythropoietin that increases the number of red blood cells. They are generally prescribed to patients with kidney or cancer in the event that they become anemic. However, patients with chronic kidney failure are sometimes more likely to suffer increased risk of death, blood clots, strokes and heart attacks if prescribed too high a dosage of the drugs. In other studies, patients with head and neck cancer had more rapid tumor growth if they used higher-than-recommended doses. Additionally some studies showed an increased blood clot risk among cancer patients who were not receiving chemotherapy and in patients following orthopedic surgery.

The new boxed warning states that Erythropoiesis-stimulating agents (ESAs) increased the risk of death and serious cardiovascular problems when given at higher than recommended doses. The FDA also suggested that higher doses could lead to blood clots.

The recent stern warnings will advise physicians to prescribe the lowest possible doses of the EPAs that prevent blood transfusions. Previously, in dialysis patients, doctors would aim for a near normal level of hemoglobin. That required greater amounts of drugs, but it has now been shown to also cause a greater incidence of side effects.

If you or a loved one has been prescribed one of these drugs for anemia, we suggest that you consult your primary care physician in light of recent findings. For more information contact the Law Offices of Michael J. O'Connor & Associates at 800-518-4529 or visit our website to fill out one of the contact forms (http://www.oconnorlaw.com/). The initial consultation is free and the firm works on a contngency fee basis, so you pay nothing unless we recover money for you.