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In most developing countries, there is practically no culture of pharmacovigilance and drug safety. As a result, there is almost no evidence on the safety of drugs in public health programs.

Even in developed countries, which have, relatively, stringent regulatory authorities, several drugs have been withdrawn from the market in the past few years, including: Alosetron (then returned to market with restrictions and a label warning), Troglitazone, propulsid, cerivastatin, rofecoxib, valdecoxib, Several other products such as antidepressant and NSAIDs have received additional warnings and restrictions based on data captured from drug safety activities. In developing countries, where several million people are taking drugs for chronic diseases such as HIV/AIDS and tuberculosis, many of which are known to have serious side effects and a narrow therapeutic window, gathering safety data is imperative.

Erythropoietin is available as a therapeutic agent produced by recombinant DNA technology in mammalian cell culture. It is used in treating anaemia resulting from chronic kidney disease and myelodysplasia, from the treatment of cancer (chemotherapy and radiation), and from other critical illnesses (heart failure).

Twenty five (25) years after the introduction of rHuEpo into clinical practice, and despite the broad clinical usage of Epoetins, there is not enough information on those drugs adverse reacting system. 

Thus, EpoCan will enhance the knowledge on Epo adverse effects enablinga controlled treatment with a positive benefit to risk ratio. This treatment has a positive influence on the quality of life of the patients. Studies showed that patients treated with chemotherapy and suffering from anaemia, treated with Epodemonstrated significant improvements in energy level, daily activities, and overall quality of life. 

By establishing basic data for the identification patients p at risk upon treatment with the Epoetins drugs, a data that will also form a solid platform for controlled clinical trials, as well as inclusion-exclusion criteria, the EpoCan will improve and dramatically enhance the quality of life of anaemia patients all over Europe and WW that need Epoetins treatment, including pregnant women and preschool-age children.



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