January 24, 2008 — The liquid formulation of sargramostim injection (Leukine, Bayer Healthcare Pharmaceuticals) is being withdrawn from the US market, the US Food and Drug Administration (FDA) advised healthcare professionals today.
Reformulation of the product to include edetate disodium (EDTA) has been temporally linked to an upward trend in spontaneous reports of adverse reactions, including syncope, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. These events have not been reported in connection with the lyophilized formulation, which does not contain EDTA.
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