EMEA says studies show increased mortality in epoetin-treated patients
[appropo' to IMCL's news today..avoiding chemo is good]
Posted: June 08, 2005
LONDON (Agence de Presse Medicale for Reuters Health) - The label on all epoetins is being updated to include information about a possible increased risk of death in cancer patients taking these medications, the European Medicines Agency said on Wednesday.
"Following the publication of two clinical studies showing an increased mortality in cancer patients that were administered epoetin alfa and epoetin beta, the Pharmacovigilance Working Party has looked at the risk of tumour growth progression and thromboembolism in patients with cancer who have been treated with epoetins," the agency's scientific committee said in a statement.
The committee said it had agreed with the working party's recommendation to update the product information of all epoetins used in the treatment of anaemic cancer patients receiving chemotherapy.
The CHMP at its May meeting adopted changes for the product information of centrally authorised epoetins in this indication -- including blockbusters such as Amgen's Aranesp and Roche's NeoRecormon. Harmonisation of the product information of nationally authorised epoetins will be done in line with the relevant legal framework, the statement added.
An agency spokesman was not immediately able to give details of the new labels or say which two studies the committee was referring to. A study, published in The Lancet in October 2003, found that that although epoetin beta therapy can correct the anemia seen in head and neck cancer patients undergoing radiotherapy, it does not improve survival and may even impair disease control.
The findings were based on a randomized trial of 351 head and neck cancer patients with anemia who were treated with radiotherapy. The anemia resolved in 82% of epoetin-treated patients, compared with 15% of those who received placebo.
But despite this seemingly beneficial effect, locoregional progression-free survival was actually significantly worse in the epoetin group. Compared with controls, patients in the epoetin group were 69% more likely to experience locoregional progression and 39% more likely to die.
The study authors speculated at the time that because some cancers express erythropoietin receptors, stimulation of these receptors by the medication might promote tumour growth.
The study was funded by Roche, which produces epoetin beta under the trade name NeoRecormon. The company did not immediately return calls.
|
