SAFETY OF BIOLOGICAL PREPARATIONS AND SMALL MOLECULES. ARE THERE ANY DIFFERENCES?

• Main Authors: A. S. Kolbin, A. V. Kharchev
• Format: Article
• Language: English
• Published: Paediatrician Publishers, LLC 2013-05-01
• Series: Pediatričeskaâ Farmakologiâ
• Subjects: pharmacovigilance; biopharmaceutical; safety; adverse side reactions and phenomena
• Online Access: https://www.pedpharma.ru/jour/article/view/215

A considerable number of biopharmaceuticals have recently been introduced into clinical practice. Their role is becoming more and more important in managing various diseases, including incapacitating and life-threatening diseases. The authors systematically reviewed literary data from 1990 to 2013 dedicated to studying adverse side reactions to medicinal proteins. The authors used international databases to search for publications dedicated to this issue. As a result, this analysis involves studies describing adverse reactions of such biopharmaceuticals as immunosuppressants and antineoplastic agents. Differences between biopharmaceuticals and small molecules in the rate of adverse phenomena, structure and severity of their manifestations are shown. Classification of adverse reactions and possibility of its use in terms of biopharmaceuticals, recommendations and conclusions for the Russian pharmacovigilance system are given.