Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded

Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.

From:
Medicines and Healthcare products Regulatory Agency
Published
20 May 2015
Therapeutic area:
Paediatrics and neonatology

When using epoetin beta for preventing anaemia of prematurity:

  • consider the benefits and risks, including the possible risk of retinopathy
  • monitor the infant for features of retinopathy
  • advise parents or carers that their baby’s eyes will be carefully monitored for any ill effects
  • report suspected side effects to epoetin beta or to any other medicine on a Yellow Card

Epoetin beta (NeoRecormon) is licensed for the prevention of anaemia of prematurity in infants with a birth weight of 0.75 to 1.5 kg and a gestational age of less than 34 weeks. Epoetin beta is identical to erythropoietin, a hormone that stimulates the production of red blood cells.

Infants born before 31 weeks of gestation, particularly those weighing less than 1.25 kg have an underlying risk of retinopathy of prematurity.[footnote 1]

Evidence for retinopathy caused by epoetin beta

A European review has considered the current evidence for retinopathy associated with epoetin beta treatment of anaemia of prematurity. Two Cochrane systematic reviews assessed the effectiveness of treatment of anaemia with erythropoietin in premature and/or low birth weight infants. One focused on treatment started within 7 days after birth,[footnote 2] the other studied treatment started 8 to 28 days after birth.[footnote 3] The systematic reviews also considered adverse effects, including retinopathy of prematurity.

Taken together, the 2 systematic reviews suggest that epoetin beta may increase the underlying risk of retinopathy in premature infants.

The summary of product characteristics will be amended to include this possible risk of retinopathy. The European review of available data concluded that more data are needed to draw a firm conclusion about erythropoietin and the risk of retinopathy of prematurity. However, the available data show that an increase in the underlying risk of retinopathy in premature infants with early epoetin use cannot be excluded.

Article citation: Drug Safety Update volume 8 issue 10 May 2015: 3

  1. Matthew MRK and others. ‘Retinopathy of prematurity: are we screening too many babies?’ Eye 2002: Volume 16, issue 5 pages 538–542 (viewed 20 May 2015) ↩

  2. Ohlsson A, Aher SM. ‘Early erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants’ Cochrane Database of Systematic Reviews 2014: Issue 4: article number: CD004863 (viewed 20 May 2015) ↩

  3. Aher SM, Ohlsson A. ‘Late erythropoietin for preventing red blood cell transfusion in preterm and/or low birth weight infants’ Cochrane Database of Systematic Reviews 2014: Issue 4, article number: CD004868 (viewed 20 May 2015) ↩

Published 20 May 2015