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Published on 11 March 2008

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Call for black-box warnings on ESAs


The FDA has requested manufacturers of erythropoiesis-stimulating agents to add to the prescribing information for these drugs “black-box” warnings regarding a reduced survival rate when used in oncology patients.

According to a Reuters Health News report, the warning will state that the drugs shortened overall survival, or caused more rapid tumour growth, in clinical studies in patients with breast, non-small-cell lung, head and neck, lymphoid and cervical cancers, when given at high doses.


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