Leukine withdrawn from market due to EDTA-related adverse events

January 28, 2008

Sargramostim withdrawn from market

Bayer HealthCare Pharmaceuticals has announced the withdrawal of growth factor sargramostim (Leukine) following an upward trend in adverse events (including syncope) in patients receiving the liquid formulation of the product. According to the company, the adverse reactions are thought to be due to the edetate sodium (EDTA) that is contained in the liquid product. Bayer said it will reformulate the liquid to eliminate EDTA. In the meantime, the company will establish a special access program for distribution of lyophilized sargramostim, which does not contain EDTA and is not associated with the reported adverse events. The program will be an interim step to provide priority access to the lyophilized drug until adequate supply can be manufactured and the liquid reformulated. Information on returning affected inventory and questions regarding the access program can be found online at