The Pharmaceutical Journal Vol 267 No 7175 p733-738
24 November 2001

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Safety update for epoetin alfa

The Medicines Control Agency has been made aware of 40 cases of confirmed or suspected pure red cell aplasia in patients with chronic renal failure treated with epoetin alfa (Eprex).

The MCA says that the overall estimated reporting rate of this adverse reaction appears to be less than one in 10,000, which it describes as very rare. It adds that typically, patients suffering from this reaction develop sudden worsening of anaemia unresponsive to increasing doses of epoetin alfa and have detectable antibodies to erythropoetin in their serum.

The MCA advises that if pure red cell aplasia is diagnosed, therapy with epoetin alfa should be discontinued and the patient should not be switched to any other brand of erythropoetin.

Epoetin alfa is used for the treatment of anaemia associated with chronic renal failure, cancer chemotherapy, autologous blood donation, and during elective orthopaedic surgery.

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