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Bayer’s liquid Leukine withdrawn

Executive Summary

Bayer withdraws current liquid formulation of myeloid growth factor Leukine (sargramostim), used to boost immunity in patients undergoing cancer treatment, due to an increase in spontaneous reports of adverse reactions including syncope (fainting). AEs are linked to a change in the formulation of liquid Leukine to include EDTA (edentate disodium). While the firm works to increase supplies of lyophilized Leukine - for which no safety signal was observed - and reformulate the liquid product, it will provide priority access to the lyophilized formulation to oncologists and hematologists who use the drug to treat patients following induction chemotherapy in acute myelogenous leukemia and bone marrow transplantation failure or engraftment delay...

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