Postmarketing safety of eltrombopag olamine : an analysis of the FDA Adverse Event Reporting System (FAERS)

Objective This study aims to investigate the risk factors associated with adverse events related to the novel thrombopoietin receptor agonist, eltrombopag olamine, with the intention of providing guidance for safe clinical medication practices. Methods Adverse drug event (ADE) reports from the US Food and Drug Administration's Adverse Event Reporting System (FAERS) spanning from the first quarter of 2004 to the third quarter of 2023 were collected and subjected to statistical analysis based on the System Organ Classification (SOC) and Preferred Terms (PT) as defined by the International Dictionary of Medical Terms (MedDRA). The report ratio method (ROR) and the proportional report ratio method (PRR) were used. Results A total of 10,357 adverse drug reaction (ADR) reports, with eltrombopag olamine identified as the primary suspected drug, were retrieved from the FAERS database. These reports included 228 risk signals at the Preferred Term (PT) level and 22 signals overall. The three most frequently reported adverse events were decreased platelet count, death and increased platelet count. The three adverse events with the highest signal intensity were increased reticulin, reticular fibrosis of bone marrow and leukopenia, respectively.Among the adverse reactions not specified in the instruction manual for eltrombopag olamine are ascites associated with gastrointestinal diseases, blistering of the oral mucosa, iron deficiency, and emaciation related to metabolic and nutritional disorders, as well as Alzheimer's dementia among various nervous system diseases, and other signals. There is no conclusive evidence to dismiss a correlation with eltrombopag olamine. The primary risks associated with SMQ drugs include hematopoietic cytopenia, various forms of bleeding, embolism, and thrombosis. Conclusion Eltrombopag olamine has been demonstrated to be safe, with the majority of prominent risk signals aligning with known adverse reactions associated with the blood and lymphatic systems, as outlined in the prescribing information. It is recommended that clinicians exercise caution regarding the potential risks of paroxysmal nocturnal hemoglobinuria, abnormal platelet counts, hemorrhage, and hearing loss when administering eltrombopag olamine in a clinical setting.