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Published on 29 September 2008

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Drug deaths prompt risk review

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Nearly a fifth of stroke patients in an anti-anaemia drug trial died compared with a tenth of those who did not take the drug, according to a US Food and Drug Administration (FDA) report of a German study.

The study investigated whether Epoetin alfa can improve the neurological functioning of patients who have experienced a stroke.

The drug is marketed as Eprex in Germany and as Procrit and Epogen in the US, and is the only product within the class of erythropoiesis-stimulating agents (ESAs) approved by the FDA for its use in the treatment of certain patients with anaemia. No ESA is approved in the US for treating stroke patients.

Most of the patients were not anaemic, and the increased mortality of patients receiving Epoetin alfa highlights the importance of evaluating whether the potential benefits for patients enrolled in other neuroprotection studies of the drug outweigh the risks.

The FDA said it will work with the manufacturers of ESAs and other sponsors of clinical studies to evaluate the risks and benefits associated with the investigational uses of these ESA products as potential “neuroprotective agents.”

In the US, Epoetin alfa was licensed by Amgen, of Thousand Oaks, California. Procrit and Eprex are marketed by Johnson & Johnson of New Brunswick. Epogen is marketed by Amgen.

Copyright PA Business 2008

US Food and Drug Administration



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