RADIOGRAPHIC CONTRAST MEDIA-INDUCED ADVERSE REACTIONS WITH COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING IN SOUTH INDIAN TEACHING HOSPITAL- PROSPECTIVE STUDY

Author(s)

Rajesh R1, Anjali T1, Chandrakant S2
1Manipal College of Pharmaceutical Sciences, Manipal University, MANIPAL, India, 2Kasturba Medical College, Manipal University, Manipal, MANIPAL, India

OBJECTIVES: To evaluate the adverse drug reactions (ADRs) from radiographic contrast media used for computed tomography and magnetic resonance imaging (MRI). METHODS: A prospective intensive monitoring study was carried out in department of radiodiagonsis and imaging, Kasturba Hospital Manipal. The Institutional Ethics Committee (IEC 411/2013) approved this study. Patients meeting the study criteria were considered for the enrollment in the study. Those patients who receives radiocontrast media intravenously in the diagnostic procedure, intensively monitored for occurrence of ADRs during their hospital stay. Patient interview also performed to get details about ADRs. Results were analyzed using descriptive analysis and Pearson’s Chi-square test to determine the relationship between the ADRs and the factors. Reported ADRs analyzed for patients demographics characteristics, WHO and Naranjo’s causality, severity, predictability, preventability. RESULTS: Total of 485 patients were enrolled in the study, 62 patients developed 75 ADRs. The overall incidences of ADRs were 12.8%. Acute reactions were found to be in 15 patients, delayed reactions in 46 patients,  Asthma was found to be increasing the risk of developing ADR. Most of the ADRs are under mild (72%) category, moderate and severe reactions were found to be 24% and 4% respectively. Most frequently reported organ system were found to be gastrointestinal (25.3%), skin and appendage ( 18.6%) and Body as whole general disorder (37.3%). Overall incidence of ADR from MRI contrast media was found to be 3.4%.Total of 116 patients enrolled in this study. Female and neoplasm patients had higher incidence of ADRs.  High incidence found in younger people (25 to 44 years). All the ADRs were under mild category. Most of the ADRs were found to be associated with Gastro-intestinal system and Body as whole general disorders. CONCLUSIONS: Incidence of adverse drug reaction from radio contrast media were found to be less but special care should be given for high risk patients.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PRS3

Topic

Epidemiology & Public Health

Topic Subcategory

Safety & Pharmacoepidemiology

Disease

Respiratory-Related Disorders

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