Risk Analysis of Drug Adverse Reaction: in Case of PPA

The risk managements for marketing products are generally based on the risk assessment of adverse reactions. Sometimes, marketing medicines shows unwanted adverse reaction, because in pre-marketing safety data with limitations of patients numbers the adverse reaction with low prevalence rate can not be easily detected. The association between unwanted adverse reaction and marketing medicine can be studied by following types; case report, case series study, case-control study, cohort study. In August, 2004, the KFDA banned the production and sale of cold remedies containing phenylpropanolamine(PPA), while US FDA requested drug companies discontinuing marketing products -containing PPA, in November, 2000. Both of regulatory decisions in USA and Korea were based on the case-control studies about an association between hemorrhagic stroke and PPA-containing appetite suppressants and cold remedies, respectively. The regulatory history of PPA in USA and the comparative analysis of the case-control studies in USA and Korea on an association between hemorrhagic stroke and PPA are presented in this symposium.