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19 Dec 2003:
Case reports of leukaemia and myelodysplastic syndrome in healthy donors treated with granulocyte colony-stimulating factor (G-CSF)

There are two brands of G-CSF approved in Singapore, namely lenograstim (Granocyte®, Aventis) and filgrastim (Neupogen®, Amgen). These 2 products were licensed in August 2002 and October 2003 for the mobilisation of peripheral blood progenitor cells in healthy donors.

Recently, the Health Sciences Authority was notified of 2 cases of healthy donors in Japan who developed haematological disorders at the 1-year follow up after receiving of G-CSF for peripheral blood stem cells transplantation (PBSCT). A Dear Healthcare Professional Letter was issued to medical oncologists and haematologists.


Risk assessment

To-date, there are no literature reports of leukaemic change in healthy donors receiving G-CSF. The US package insert of Neupogen® states that Neupogen® is a growth factor that primarily stimulates neutrophils. However, the possibility that Neupogen® can act as a growth factor for any tumour type cannot be excluded”.

Whilst the causality for the development of the abnormal haematological events in the above 2 patients cannot be determined, the risk-benefit assessment of G-CSF in healthy donors is difficult to assess as the benefits of treatment accrue mainly to the recipient.


HSA's recommendation

HSA recommends that healthy donors be followed-up for a minimum of 1 year to check that their haematological indices are normal. Physicians are reminded to investigate any baseline haematological abnormalities in donors. G-CSF should not be used if haematological diseases are suspected. When prescribing these drugs to the elderly, caution should be considered as they are at a higher risk for developing leukaemia.

Healthcare professionals are encouraged to report all cases of suspected serious ADRs on the use of G-CSF, particularly in healthy donors.


Last updated on 02 Jul 2010 16:55:35
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