A study on adverse drug reactions to non-ionic contrast medium in an Indian population: a 1-year experience.
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Date
2014-11
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Abstract
Background: To the best of our understanding, very few studies focusing on the
adverse drug reaction (ADR) profile of non-ionic contrast medium (NICM) has been
carried out until date among the Indian population. Hence, this study was planned.
We sincerely believe that the knowledge gathered from this study can improve
safer usage of these agents among the patients of Indian origin. The objective was
to evaluate the incidence and severity of ADRs of non-ionic radio contrast media
(CM) used in tertiary care hospital in Eastern India.
Methods: For the duration of 1-year from July 2011 to July 2012, we prospectively
recorded all the ADRs associated with the administration of NICM (iohexol and
ioversol) in 3708 patients of Indian origin undergoing computed tomography scan at
the hospital. The average median age, weight, dose used; types of ADRs, concomitant
medication, final diagnosis, reasons for use were recorded and analyzed with
appropriate statistical tools. Causality assessment was performed using Naranjo scale.
Results: Eleven of 3708 patients who received either ioversol or iohexol developed
ADRs (i.e. 0.3% of patients). The most common ADR was rigor. The incidences of
mild, moderate and severe reactions were 55%, 36% and 9%, respectively. Average
median age, weight, and dose used were 35 years, 66 kg and 70 ml, respectively. All
the ADRs were early (occurred within 1 hr of CM administration). Due to logical
constraints, the follow-up of these patients was not possible and hence late ADRs
were not captured. The common concomitant medication used was pantoprazole
(63.63% of patients). The difference in the incidence of ADRs by age distribution
(Group 1 - Iohexol, Group 2 - Ioversol) and weight distribution was not statistically
significant (p=0.75 and p=0.18, respectively). Causality analysis revealed that all
the ADRs were possible (Score of 4). Interestingly, the incidence of reactions was
noted to be higher in patients with a history of gastro intestinal disorders (45.45%).
Conclusions: This pilot study reveals that adverse reactions to NICM are rare and
severe reactions are less common among the patients of Indian origin. However, a
larger multicentric study across the country should be carried out to understand the
safety profile of these CM better among the Indian population.
Description
Keywords
Adverse drug reaction, Non-ionic contrast medium, Non-ionic contrast medium, Pharmacovigilance
Citation
Bhowmick Subhrojyoti, Bhat Esha, Panja Buddhadev, Mukherjee Satarupa, Sikdar Shreya, Biswas Arnab, Ejaz A Bari, Chatterjee Tapan K. A study on adverse drug reactions to non-ionic contrast medium in an Indian population: a 1-year experience. International Journal of Basic & Clinical Pharmacology. 2014 Nov-Dec; 3(6): 1066-1071.