News
FDA Orders Label Change for Popular Anemia Drugs
August 14, 2008
On July 30, 2008, the Food and Drug Administration (FDA) notified the public that it was ordering a label change of popular anemia drugs, Epogen, Procrit and Aranesp. Recent research indicates that Epogen, Procrit and Aranesp pose a significant danger to patients with certain cancers and/or insufficient hemoglobin counts.
Epogen, Procrit and Aranesp are Erythropoiesis Stimulating Agents (“ESA”) and are used to treat anemia, a condition that arises when a body fails to produce a sufficient number of red blood cells. Often, anemia occurs in cancer patients or in patients suffering from renal failure. Traditionally, in order to combat the anemia and stimulate red blood cell production, these patients were prescribed one of the three major ESA’s on the market - Epogen, Procrit or Aranesp.
Results of recent FDA testing indicates that Aranesp, Epogen, and Procrit increased the risk for death and serious cardiovascular events when patients were given high doses of the drug. In patients with breast cancer, non-small cell lung cancer, head and neck cancer, lymphoid cancer and cervical cancer, Epogen, Procrit and Aranesp caused faster tumor growth in patients who received higher doses of the drug. Overall, the FDA required Aranesp, Epogen and Procrit labels to be changed to reflect the fact that the lowest possible dose should be given in order to avoid these serious side effects.
If you or someone you know has been injured as the result of Epogen/Procrit or Aranesp exposure or have experienced symptoms of Epogen/Procrit or Aranesp injury, please contact us for a free consultation at our toll free number at 1-800-873-5297 or by emailing Beth Wilkins at .