Bayer USA withdraws Leukine 500mcg vials

Germany's Bayer HealthCare will withdraw the current liquid formulation of its recombinant granulocyte-macrophage colony stimulating factor Leukine (sargramostim) from the US market after consultation with the Food and Drug Administration, in light of adverse reactions, including fainting, linked to 500mcg vials of the drug which contain the chelating agent edetate disodium (EDTA).

While Bayer works to increase supplies of lyophilized Leukine and reformulate the liquid Leukine to eliminate EDTA, it says it will establish a special access program for the currently-marketed lyophilized Leukine 250mcg vial which does not contain EDTA. The firm stressed that only the 500mcg vials are affected, adding that the adverse events which have prompted the recall are already listed in the agent's prescribing information.

The special access program is designed to prioritize the supply of the lyophilized Leukine for patients with acute myelogenous leukemia and those who are experiencing bone marrow transplantation engraftment failure or delay. Leukine is the only myeloid growth factor approved to reduce the incidence of infections resulting in early death following induction chemotherapy in older adults with AML and to prolong survival of patients with bone marrow graft failure or engraftment delay, as compared to historical experience. The special access program will also be used to provide continued Leukine therapy to patients currently participating in ongoing clinical studies, Bayer noted.