Bayer has announced a new liquid formulation of sargramostim (Leukine), approved by the US Food and Drug Administration, which no longer contains the added EDTA in the 500 µg vials. The old liquid product, sold from January 2006 to January 2008, had been linked with side effects including fainting.
"EDTA binds many metals, mainly calcium, and this may play a part in the side effects," says Dr Mark Heaney. After talks with the FDA, Bayer withdrew the liquid form in January 2008 after reports of fainting linked with the added EDTA; no such effects were seen with the freeze-dried 250 µg vials, which don't contain EDTA.
Sargramostim is a man-made (recombinant) human granulocyte-macrophage colony-stimulating factor, which stimulates blood-forming cells to multiply and mature. It is approved for patients over 55 with acute myeloid leukaemia, given after chemotherapy to speed the recovery of white blood cells (neutrophils) and so reduce serious infections. It also speeds bone marrow recovery in patients with non-Hodgkin lymphoma, acute lymphoblastic leukaemia or Hodgkin's disease having their own bone marrow transplanted, and is used to move blood-forming cells into the blood so they can be collected (leukapheresis).
"Only two drugs are approved to improve bone marrow function after chemotherapy," Dr Heaney says. Besides sargramostim there is filgrastim (Neupogen) and its long-acting form pegfilgrastim (Neulasta). No clinical trials have shown a difference in bone marrow recovery between them, and some studies suggest that if one doesn't work, adding the other sometimes helps: they complement each other. Sargramostim has been used to treat 200,000 cancer patients.
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