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

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.

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