Data Analysis of Severe Adverse Events using FDA AERS database

Abstract

Although almost all kinds of drugs carry a certain level of risk of side-effects, because of the Japanese strict approval process, serious adverse reactions are rarely developed. However, especially when such serious and rare adverse reactions are developed, they tend to be late to be diagnosed as their side-effects. The Ministry of Health, Labor and Welfare made a manual of the serious adverse reaction since 2006. The ministry also has been prompting the research on the pathogenesis of such significant adverse reactions.After reporting Stevens-Johnson syndrome (SJS) by the two American pediatricians, A. M. Stevens and F. C. Johnson in 1922, the differences among SJS, erythema multiform (EM) and toxic epidermal necrosis (TEN) have been discussed. However, still, little chemical information, which can reveal the drugs developing SJS more often than erythema multiform (EM), is known. In this study, we aimed to find several partial structures as well as molecular properties which develop SJS more often than EM using logistic regression analysis with various kinds of molecular chemical descriptors. As the result, fairy good correct classification ratios were obtained and the numbers of quaternary carbon atoms was constantly remained as a significant descriptor of the discrimination analysis.