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Review of Anaemia Drugs: Aranesp, Epogen, Procrit (Eprex)

A US Food and Drug Advisory panel (FDA) assembled on Thursday, 13 March 2008 in Gaithersburg, to vote on the continued use of anaemia drugs for cancer patients. The panel convened due to a recent discovery that showed anaemia drugs are linked to increased mortality and faster-spreading tumours, when large doses of the drug are consumed.

Amgen are manufacturers of Aranesp and Epogen. Johnson & Johnson produce Procrit, which is registered in Ireland under the pharmaceutical name Eprex. These drugs are used to treat anaemia in patients that suffer from kidney failure i.e. patients undergoing kidney dialysis and in cancer patients who undergo chemotherapy treatment. The purpose of the drug is to stimulate bone marrow to produce red blood cells. It acts similarly to a naturally occurring protein called erythropoietin. As a result it is referred to as an erythropoietin stimulating agent (ESA).

Documents posted by the FDA on Tuesday 11 March, 2008, portrayed that that patients with cancers of the breast, head, neck, lung and cervix are at greater risk of mortality and faster-spreading tumours. Eight clinical trials conducted gave light to this evidence. In these documents FDA officials stated "Whereas at the time of approval safety concerns were theoretical, there is now mounting evidence of documented effects on survival, tumor progression, and thrombotic events which require a re-assessment of the net benefits of this class of drugs,"

At an assembly of the FDA on 13 March 2008, continued use of anaemia drugs for cancer patients undergoing chemotherapy was recommended, however with a warning that certain cancer patients should not consume the medication i.e. cancer patients that are likely to be cured, or patients suffering from breast, neck or head cancer.

Previous advertisement of Aranesp, Epogen and Procrit (Eprex) claimed these drugs lessen fatigue and improved quality of life for anaemic patients with HIV and cancer, despite a lack of evidence to confirm the claim. In November 2007 the FDA stipulated that a "black box" must be added to the medication to warn consumers of adverse effects with high dosage. It was recommended that ESA's should be used in low dosages to avoid risks of blood clots, heart attacks, strokes, increased tumour growth and increased mortality.

During the assembly on 13 March, 2008, it was agreed that the "black box" should be amended to include warning of increased tumour growth and heightened risk of mortality in patients with breast cancer and cervical cancer.

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