Important Drug Warnings Issued

The FDA recently 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 disease 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 of the dangerous drug could lead to blood clots.

Director of the FDAs Center for Drug Evaluation and Research, Steven Galson said The agency is in the process of re-evaluating the safety of Aranesp, Epogen, and Procrit on the basis of the results of recent clinical studies. The new studies provide significant new information for both prescribers and patients, and the new information applies to all ESAs, which share the same mechanism of action. The safety of these products will be discussed when the Oncologic Drugs Advisory Committee (ODAC) meets in May and further revisions to the labeling may occur after that meeting.

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.

Dr. Eric P. Winer, chief of the breast cancer center at Dana-Farber Cancer Institute in Boston said that these drugs have been somewhat overused. I dont think its been without some effort on the marketing end. There has been a tendency I think for patients, and to some extent health providers, to attribute more fatigue to anemia than deserves to be attributed.

If you or a loved one has been prescribed one of these defective drugs for anemia, we suggest that you consult your primary care physician in light of recent findings.

For more information about these or other specific drug injuries, please feel free to call our office at 1-877-333-1000. We are available 24/7 to answer your questions. You can also obtain more information by visiting http://www.demayolaw.com/drugs.html

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