Leukine recall – pro
LEUKINE has been FDA approved for use in multiple indications: For use following induction chemotherapy in older adults with Acute Myelogenous Leukemia (AML)
For use in myeloid reconstitution after autologous bone marrow transplantation
For use in myeloid reconstitution after allogeneic bone marrow transplantation
For use in transplantation (BMT) failure or engraftment delay
For use in mobilization and following transplantation of autologous peripheral blood progenitor cells.
It is guideline (NCCN, ASCO) recommended for preventing and treatment of febrile neutropenia. ALthough it is an unusual choice (usually Neupogen or Neulasta would have been used), it remains a guideline recommended treatment and, therefore, medically necessary.
On 1/24 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 The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the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.
http://www.fda.gov/medwAtch/safety/2008/Leukine_DHCP_01-23-2008.pdf
nccn.org, neutropenia