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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.