Adverse Drug Reactions in COVID-19 patients admitted to Intensive care unit: Analysis of individual case study reports

Abstract Background Occurrence of adverse drug reactions in COVID-19 patients has not been extensively studied. Thus the present study was conducted to analyze the pattern of suspected Adverse Drug Reactions in COVID-19 patients admitted in Intensive Care Unit. Methods In this observational study, all the individual case study reports of patients admitted to the COVID ICU from August to October 2020 were analyzed. The type of ADR, the system involved, drug history, the suspected drug, reaction time and time to revert and management of ADR were recorded. ADRs were classified as serious and non-serious and causality was assessed using the WHO-UMC scale. The severity of ADRs was determined using Hartwig Scale. Results From 395 patients admitted to the COVID ICU during the study period, 44 individual case reports were received of 36 patients. Dermatological manifestations were the most frequent ADRs reported in this study, followed by gastrointestinal. Remedesivir was the most common drug associated with ADRs. The female gender, use of more than 5 drugs and presence of comorbidities were the independent risk factors for the occurrence of ADRs in patients with COVID-19. Conclusion The use of many of these drugs in this pandemic is experimental and so far the data available in the literature does not guarantee the safety and efficacy for COVID-19 treatment. Therefore, during these times of uncertainty, the results from present study reinforce the importance of monitoring patients. Early diagnosis and management of ADRs is warranted.