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Published on 9 November 2007

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FDA releases new warnings on ESAs


The Food and Drug Administration (FDA) has approved new boxed warnings and other labelling changes for erythropoiesis-stimulating agents (ESAs), which treat certain types of anaemia.

The warnings have been formatted to alert patients with cancer and chronic kidney failure to the risks around Aranesp (darbepoetin alfa), and the branded epoetin alfa drugs Epogen and Procrit.

The labelling changes also include a statement that symptoms of anaemia, fatigue and quality of life have not been shown to improve in patients with cancer who are treated with ESAs.

Epogen and Procrit are also approved for use in certain patients with anaemia who are scheduled to undergo major surgery to reduce blood transfusions during or shortly after surgery, and for the treatment of anaemia caused by zidovudine therapy in HIV patients.

Dr Janet Woodcock, the FDA’s deputy commissioner for scientific and medical programmes, said: “Healthcare professionals need to consider the risks of increased tumour progression and decreased survival in patients with cancer when prescribing ESAs.

“ESAs should be used in patients with cancer only when their anaemia is due to chemotherapy and only at the lowest dose necessary to avoid the need for blood transfusions.”

Copyright © PA Business 2007


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