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Table 3 Summary of the serious ADRs reported in EudraVigilance database (as per January 2014) [22]

From: Efficacy and safety data of subsequent entry biologics pertinent to nephrology practice: a systematic review

Active ingredient Brand name Serious ADR reports
HX 575 Abseamed® 10 cases total
1 case of PRCA
1 case of anemia
2 cases of decreased hemoglobin
2 cases of convulsion/epilepsy
1 case of DVT
  Binocrit® 36 cases in total
1 case of anemia
2 cases of PRCA
4 cases of decreased hemoglobin
1 case of retinal artery occlusion
3 cases of chest pain
2 cases of pulmonary embolism
2 cases of hypertension
1 case of angiopathy
  Epoetin Hexal® 4 cases in total
3 cases of decreased hemoglobin
1 case of PRCA
1 case of heart failure
Epoetin zeta Retacrit® 39 cases in total
1 case of anemia
2 cases of decreased hemoglobin
2 cases of myocardial infarction
4 cases of death
2 cases of drug ineffectiveness
1 case of stroke
1 case of convulsion
1 case of carotid artery stenosis
1 case of pulmonary embolism
1 case of hypertensive crisis
2 cases of thrombosis
  Silapo® 6 cases in total
1 case of PRCA
1 case of deceased hemoglobin
2 cases of drug ineffectiveness
1 case of hypertension crisis
Epoetin theta Eporatio® 7 cases in total
3 cases of PRCA
1 case of anemia
1 case of decreased hemoglobin
1 case of angina
1 case of epilepsy
3 cases of drug ineffectiveness
  Biopoin® 1 case in total
1 case of PRCA
  1. ADRs = Adverse drug reactions; PRCA = Pure red cell aplasia.
  2. N.B.: Each reported case may contain one or multiple suspected ADRs. Only ADRs commonly attributed to epoetin therapy are listed above.