Investigation of the Safety of Radiopaque Compounds Based on Notification Cards on Adverse Reactions Registered in the Republic of Crimea

Objective. At the present stage of medicine development, the use of X-ray contrast agents tends to grow constantly and more than 60 million doses of radiopaque compounds (ROCs) are annually used.The objective of the study was to investigate adverse reactions (ARs) arising from the use of ROCs in patients living in the Republic of Crimea.Material and methods. The objects of the study performed were 69 notification cards on ARs to ROCs, which were registered in the regional database (registry) of spontaneous messages called ARCADe (Adverse Reactions in Crimea, Autonomic Database) in 2009–2018.Results. A larger number of cases of ARs identified in the Republic of Crimea were due to the administration of water-soluble low-osmolar ROCs (iohexol, iopromide, iodixanol) to patients for kidney examination. The main clinical manifestations were immediate hypersensitivity reactions. The number of ARs posing a threat to a patient’s life exceeded 30% of all cases of ARs registered in the Republic of Crimea. Twelve patients (17.4%) required hospitalization or its prolongation to relieve an emerging AR; temporary disability due to ARs to ROCs were observed in 2 cases. The measures to reduce the severity of ARs included drug discontinuation and correction in 65 cases (94.2%). A drug suspected of causing ARs was not discontinued in 3 cases (4.3%); however, additional drugs were needed to correct the ARs.Conclusion. Investigating the safety of ROCs on the basis of analyzing the notification cards on ARs registered in the Republic of Crimea in 2009–2018 could confirm the severity and seriousness of these reactions established by other researchers, which requires an individual approach to choosing a ROC, its dose, as well as monitoring of a patient’s health status both during the administration of agents and soon after the end of diagnostic procedures using ROCs.