FDA restricts use of erythropoiesis stimulating drugs
BMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1050 (Published 22 February 2010) Cite this as: BMJ 2010;340:c1050
- Janice Hopkins Tanne
- 1New York
The US Food and Drug Administration and a manufacturer of erythropoiesis stimulating agents have announced a new safety plan for use of these drugs in patients with cancer.
Studies found that when the drugs were used in patients with cancer they caused tumours to grow faster and led to earlier deaths in some patients (Clinical Cancer Research 2008;14:3242, doi:10.1158/1078-0432.ccr-07-1872; CMAJ 2009;180:e62-71, doi:10.1503/cmaj.090470). In April 2008 the FDA required the manufacturer, Amgen, to establish a risk management programme for these drugs.
The FDA said that such a programme was needed to ensure that the drugs’ …
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