Interferon Beta: Analysis of Information on Adverse Reactions and Evaluation of Possibility of Signal Identification

Abstract

Multiple sclerosis is one of the most common neurological diseases of working age population. The last 20 years widely use drugs that change the course of multiple sclerosis. The article is devoted to the problems of the safety of treatment of multiple sclerosis with interferon beta drugs. The aim of the study was to analyze the adverse drug reactions (ADRs) of interferon beta medicines and the assessment of the possibility of identify signals on rare adverse drug reactions based on spontaneous reporting data. A retrospective analysis of reports of ADRs that occur after the use of interferon beta-1a, interferon beta-1b was performed. The results confirm the known risks of developing ADRs of this group of drugs: general disorders and administration site conditions, nervous system disorders, musculoskeletal and connective tissue disorders and psychiatric disorders. Under-reporting of ADR was identified, high level reporting rate from manufacturers was detected. A significant number of received spontaneous reports contained information about serious ADRs (52.9 % — for interferon beta-1a; 29.4 % — for interferon beta-1b). All ADRs corresponded to those specified in the instructions for medical use of drugs. The results of the study confirmed the possibility of identifying signals associated with the occurrence of very common, common, and uncommon ADRs, such as thrombocytopenia.