Appearance of Side Effects Related to Non-ionic Iodine Contrast Medium / 医薬品情報学

ABSTRACT

<b>Objective: </b>We investigated the incidence of side effects related to contrast medium employed in our hospital based on monitoring materials to improve the safety of contrast-enhanced examinations.  Furthermore, we compared the incidence of side effects between the original product and generic drugs to confirm the safety of each preparation.<br><b>Methods: </b>The survey period was from April 2007 until March 2011.  Based on the number of patients who underwent contrast-enhanced examinations and that of patients with side effects, we calculated the incidence of side effects in our hospital, and confirmed its annual changes.  Subsequently, we again collected the incidence of side effects per each manufacturer’s preparation employed, and confirmed the state of side effects of individual preparations.  Furthermore, we evaluated the symptoms as side effects, interval until appearance, and treatment for side effects during the data collection period, as well as the subsequent state, symptoms as side effects, and interval until appearance.  The chi square independence test was employed to compare the results among groups.  <i>p</i><0.05 was regarded as significant (paired test).<br><b>Results: </b>There were no changes in the annual incidence of side effects.  There were also no significant differences in the annual incidence of side effects among the preparations.  Furthermore, there were no marked differences in the symptoms, interval until appearance, treatment for side effects, or subsequent state among the preparations.<br><b>Conclusion: </b>We investigated the appearance of side effects regarding contrast-enhanced examinations for 4 years.  We confirmed that there were no differences in the incidence of side effects among the preparations.