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sargramostim FDA Alerts

The FDA Alert(s) below may be specifically about sargramostim or relate to a group or class of drugs which include sargramostim.

MedWatch Safety Alerts are distributed by the FDA and published by Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for sargramostim

Leukine (sargramostim)

Jan 24, 2008

Audience: Oncologists, hematologists, other healthcare professionals

[Posted 01/24/2008] Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.

[January 23, 2008 - Dear Healthcare Professional Letter - Bayer Healthcare]

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