Reported Adverse Drug Reaction Cases
Indapamide and hyponatraemia
Pure red cell aplasia (PRCA) is a rare adverse effect of epoetin alfa, which has recently been highlighted in an article and subsequent letter in the literature.1,2 The condition results from the development of antierythropoietin antibodies, resulting in transfusion-dependent anaemia. PRCA has been reported only after chronic use of epoetin in patients with renal failure. In a series of 82 cases reported by the FDA, PRCA developed after the use of epoetin alfa from 1 month to 5 years (median: 7 months).
ADRAC has received 12 reports of PRCA associated with epoetin alfa (Eprex) use. The ages of the patients ranged from 28 to 76, and duration of epoetin use, where known, was from 4 to 13 months.
Antierythropoietin antibodies which develop in this condition cross-react with all other erythropoietin products, including darbepoetin (Aranesp) which has been available in Australia since November, 2001. Experience with this product is limited, specifically it is not known whether PRCA will develop in association with darbepoetin as the only agent used.
The sponsor of Eprex has recently issued a 'Dear Healthcare Professional' letter, recommending that Eprex be given by the intravenous route where feasible, as this is thought to reduce the risk of antibody formation.
In patients with worsening anaemia, other causes (eg, iron, folate, or Vitamin B12 deficiency; aluminium intoxication; infection or inflammation; blood loss or haemolysis) should be excluded. If PRCA is suspected it should be confirmed with antibody testing and/or bone marrow examination. Epoetin alfa should be discontinued, and patients should not be switched to another erythropoietin. PRCA may respond to immunosuppressive therapy, spontaneous resolution has occurred occasionally.
Please report all cases of suspected PRCA to ADRAC. Antibody testing can be arranged through Janssen Cilag - phone 1300 369 949.