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FDA issues safety alert for market withdrawal liquid Leukine (Bayer)
As a service to our members, ASCO is providing information about Bayer’s market withdraw of liquid Leukine®. All questions should be directed to Bayer HealthCare Pharmaceuticals toll-free at 1-888-84Bayer (1-888-842-2937).
Bayer HealthCare Pharmaceuticals, in consultation with the FDA are informing oncologists, hematologists and other 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. Leukine® is presently marketed under the Berlex Laboratories name.
It is important to note that the upward trend in reporting rates for certain adverse events ( increase in reporting rates of syncope, with or without documented hypotension) is only associated with the current liquid Leukine ® containing EDTA. The lyophilized formulation of Leukine® is not affected.
Bayer is withdrawing current stock and no longer accepting new orders, nor will any existing orders be fulfilled of the liquid Leukine®. Healthcare professionals are to return all supplies of liquid Leukine®5oo mcg vials to Bayer. Questions can be directed to Bayer HealthCare Pharmaceuticals toll-free at 1-888-84Bayer (1-888-842-2937). The “Dear Health Care Professional” letter and background information can be viewed on the FDA MedWatch site
