Follow epoetin indication and dosing restrictions, EMEA says
Epoetin products should be used strictly in accordance with the indications
and dosing recommendations set out in their summaries of product characteristics,
the European Medicines Agency (EMEA) has warned this week in a public
statement (PDF 40K).
The EMEA is reviewing the safety of all epoetin products centrally authorised
by the agency in light of new data that suggest a possible effect on
tumour progression in patients with cancer and an increased risk of serious
cardiovascular complications in patients with chronic renal failure.
A review by the EMEA’s Committee for Medicinal Products for Human
Use (CHMP) and its Pharmacovigilance Working Party undertaken in 2004
resulted in revised dosing recommendations for the use of epoetins in
patients with cancer. The EMEA is now reminding prescribers that epoetins
are only authorised for the treatment of anaemia in patients with solid
tumours who are receiving chemotherapy. “There is some evidence
that epoetins may be associated with increased morbidity and mortality
when used in patients with solid tumours not receiving chemotherapy,” it
stresses.
The agency says there is evidence that aiming for a target haemoglobin
concentration above 12g/dl when treating chronic renal failure patients
with epoetins is associated with an increase in mortality and serious
cardiovascular morbidity. The EMEA writes: “The CHMP is currently
holding further discussions with expert groups to consider whether tighter
dosing instructions should be issued in this regard. In the meantime,
physicians should exercise caution when considering raising haemoglobin
concentrations above 12g/dl.”
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