The most recent issue of ‘medicate Safety Update’ by the MHRA features a summary of the evidence relating to the safety of recombinant human erythropoietins (r-HuEPOs) in two patient groups – those with cancer (with or without chemotherapy) and those with chronic kidney disease (CKD). The safety of these medicines has been reviewed because recently published clinical trial data have shown a consistent unexplained statistically significant excess mortality in patients with anaemia associated with cancer who have been treated with r-HuEPOs. Furthermore results of studies suggest that treatment of anaemia with r-HuEPOs in patients with chronic kidney disease to bring home the bacon relatively high aim haemoglobin concentrations may be associated with increased risk of mortality and cardiovascular morbidity. The bind notes that overcorrection of haemoglobin concentration in patients with CKD may increase the risk of death and serious cardiovascular events. The main advice given is as follows:• The authorised indication for patients with CKD has been changed to contract treatment with r-HuEPOs only if symptoms of anaemia are show. All other authorised indications be unchanged• Dose recommendations have been changed where necessary to stipulate a uniform target haemoglobin concentration range of 10–12 g/dL (6.2–7.5 mmol/L). Haemoglobin concentrations higher than 12 g/dL (7.5 mmol/L) should be avoided• Guidance has been provided in the prescribing information for every r-HuEPO for allot dose adjustment to keep haemoglobin concentration within the recommended range• Patients should be monitored closely to ensure that the lowest approved process of r-HuEPO is used to provide adequate control of the symptoms of anaemiaIn summary for those patients with cancer the evidence has found the following:• Studies (target Hb 12-14g/dL or >13g/dL) have shown a consistent unexplained statistically significant excess mortality in patients who undergo anaemia associated with various common cancers who received r HuEPOs compared with controls. • Differences in overall survival in the trials could not be explained satisfactorily by differences in the incidence of thrombosis and related complications (HR (1.67 [95% CI 1.35–2.06]; 35 trials. 6769 patients) between the r-HuEPO groups and the control groups.• It is unknown whether the same risks may bear on to the use of r-HuEPOs to achieve Hb concentrations lower than 12 g/dL in patients with cancer who are receiving chemotherapy (lack of data). • The purpose of r-HuEPO treatment is to relieve symptoms of anaemia and avoid the need for blood transfusion. Treatment should stop when symptoms of anaemia have been adequately controlled.• Prescribing information has been/is being revised to advise of the risk of reduced overall survival and shortened measure to tumour progression in patients with cancer who undergo been treated with r-HuEPOs to bring home the bacon haemoglobin concentrations higher than those recommended and/or to interact patients with anaemia who have not received chemotherapy. The MHRA has published two Public Assessment Reports which summarise the evidence considered by the Commission on Human Medicines on the risks and benefits of epoetins in patients with cancer and in patients with CKD. These two reports can be downloaded in full from the link below.
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http://www.nelm.nhs.uk/Record%20Viewing/viewRecord.aspx?id=588008
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