Three Anemia Drugs To Get Stronger Warning Labels

anemiaNov 8, 2007

Warning labels on three anemia drugs used by one million Americans undergoing chemotherapy or who have kidney failure have been strengthened to alert users about increased risk of heart attack, stroke, a worsening of their condition, and even death, said the manufacturers, Amgen and Johnson & Johnson earlier this week.

The decision, which has been made in consultation with the US Food and Drug Administration, affects Amgen’s Epogen and Aranesp, and Johnson & Johnson’s Procrit. These drugs belong to a class known as erythropoiesis-stimulating agents or ESAs.

ESAs are a bioengineered protein similar to one made in the kidneys that causes bone marrow to produce more red blood cells.

Concern about ESAs has been growing since a number of studies has revealed an increased risk of death in cancer patients with anemia that did not arise as a result of chemotherapy, that kidney dialysis patients could be overusing them, and that they increase tumour growth and reduce survival.

The US Food and Drug Administration (FDA) said yesterday, Thursday 8th November, that it had approved revised boxed warnings and other labelling changes for Aranesp, Epogen and Procrit because of the increased risks to patients with cancer and chronic kidney failure. Read More….

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