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BMJ. 2007 June 23; 334(7607): 1297.
PMCID: PMC1895649
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FDA considers curbing use of erythropoietins for patients with cancer

The controversy surrounding overuse of synthetic erythropoietins in the US has shifted lately to patients with cancer, who are given these agents for the anaemia associated with chemotherapychemotherapy.. While treatment helps patients avoid blood transfusions, the potential risks include thromboembolism (already seen in patients with chronic renal failure) and the stimulation of tumour growth, which could lead to shorter survival. The evidence of harm is patchy but worrying according to three recent comment articles, and the US Food and Drug Administration (FDA) is gearing up to place further restrictions on synthetic erythropoietins for patients with breast cancer, small cell lung cancer, and some head and neck cancers. Data from clinical trials suggest treatment with synthetic erythropoietins can reduce survival in patients with these cancers, although the principal manufacturers disagree, and few good data are available to resolve the argument. Product labels already have a “black box” warning that urges prescribers to hold off treatment in all patients with serum haemoglobin concentrations above 120 g/litre.

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Agents such as epoetin alfa are lucrative for their manufacturers and costly for the American authorities, says one article (pp 2448-51). Drug advertisements continue to overstep the evidence, citing benefits such as better quality of life that go beyond avoiding transfusions. The adverts seem to work. Medicare payments covering erythropoietins for patients with cancer increased more than fourfold between 1999 and 2004.


  • N Engl J Med 2007;356:2445-8 [PubMed]
  • N Engl J Med 2007;356:2447 [PubMed]
  • N Engl J Med 2007;356:2448-51 [PubMed]

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