Incidence of adverse drug events in COVID-19 patients on anticoagulants: a pharmacovigilance study

Abstract

Pharmacovigilance is a crucial component of today’s health science studies that allows researchers to detect, assess, understand, to ultimately prevent any adverse event associated with drugs. Today, with the world struggling to get the COVID-19 pandemic under control, it is important to look at how this disease is affecting different patient populations. A common complication associated with this disease is thrombosis. A lower mortality rate in COVID-19 patients has been related to the use of the drug heparin, a widely used anticoagulant. The main objective of this study was to assess whether there were any adverse events associated with the administration of anticoagulants in patients known to have COVID-19. Thus, it was hypothesized that with study of different anticoagulant drugs, there would be no significant difference in the observed adverse events for these drugs. Data for this study was obtained from a deidentified secondary database of COVID-19 positive patients from Truman Medical Center, Kansas City, MO and from the FDA’s Adverse Event Reporting System (FAERS) Public Database. Chi-square test of association was performed to determine associations of race, sex and hospitalization rate with the adverse outcome variables. Proportional Reporting Ratios (PRR) and lower 95% confidence intervals (Lower CI) were calculated for data from the FAERS database where the adverse events studied, mimicked COVID-19 symptoms. It was found that there is a significant association between race and hospitalization rate for patients who were on anticoagulants and had COVID-19. Additionally, the study results suggested that patients who were put on the anticoagulant heparin were more likely to develop pneumonia compared to other anticoagulating drugs. However, no reportable adverse drug event was found for any other selected anticoagulant drugs. Given the findings, it would be important for the clinicians to use heparin with caution, especially in COVID-19 patients.