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FDA committee recommends restricting use of anti-anaemia drug in cancer

BMJ 2008; 336 doi: https://doi.org/10.1136/bmj.39524.391759.DB (Published 20 March 2008) Cite this as: BMJ 2008;336:632
  1. Janice Hopkins Tanne
  1. 1New York

    The US Food and Drug Administration’s oncologic drugs advisory committee has recommended limits on the use of synthetic erythropoietin products, used to treat anaemia, in many cancer patients.

    The FDA is not obliged to follow the committee’s recommendations but often does so. A spokeswoman said that the agency “will review the information and have internal discussions before rendering its final decision.”

    FDA documents state: “Trials have demonstrated an increased risk of death and/or tumor promotion in head/neck, non-small cell lung cancer, breast (neoadjuvant and metastatic settings), lymphoid malignancies, and cervical cancers. Tumor types, other than those listed . . . have not been adequately studied.” Many of the trials used high doses of the drug.

    Erythropoietin is sold as Aranesp and Epogen by Amgen and as Procrit by Ortho Biotech, a …

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