Politics / Law

EMEA recommend label changes for epoetins

22.11.2007

London – Following the US FDA’s decision to add a black-box warning to the labels of epoetin products, the European Medicines Agency (EMEA) at the end of October recommended warning of the potential risk of tumour growth progression and thromboembolic and cardiovascular events caused by epo products. According to the EMEA’s proposal, epoetins should be used to treat anaemia only if it is associated with symptoms, and only if they don’t exceed a haemoglobin concentration of 12g/dL. Additionally, manufacturers are asked to explain that clinical studies have shown a higher mortality in association with high target haemoglobin concentrations. The decision concerns Amgen‘s Aranesp/Nespo, Roche‘s NeoRecormon, and Shire Pharmaceuticals‘ Dynepo as well as three biosimilar products: Arzneimittel Putter‘s Abseamed, Hexal‘s Epoetin Alfa Hexal, and Sandoz‘ Binocrit.

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10.12.2004

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