Drug-Induced Spontaneous Intramural Hematoma of the Gastrointestinal Tract: A Real-World Pharmacovigilance Analysis

Abstract

It is unclear whether drugs other than warfarin can cause spontaneous gastrointestinal intraluminal hematomas (SGIH). This study aimed to investigate the drugs that induced SGIH based on the US Food and Drug Administration's Adverse Event Reporting System data. A retrospective pharmacovigilance study was conducted. The disproportionality analysis was performed to assess the reports of drug-induced SGIH from the first quarter of 2004 to the fourth quarter of 2023. Logistics regression analysis was used to explore drug-related SGIH risk factors. Weibull distribution was applied for the onset time of SGIH. A total of 116 drugs associated with SGIH have been reported in the US Food and Drug Administration's Adverse Event Reporting System database. After removing duplicates, 88 unique drugs involving 210 patients were identified. These drugs can be broadly classified into 4 categories: (1) anticoagulants, (2) new direct oral anticoagulants, (3) antiplatelet agents, and (4) others. The first group is dominated by warfarin (59/210), while the second group, rivaroxaban, accounts for the most significant proportion (9/210). As for the third group, aspirin is the dominant drug (16/210), and for the fourth group, drugs that cause thrombocytopenia are dominant. The median number of reported cases was 11.5 per year, accounting for a median percentage of 0.0094% of all adverse events related to target drugs. The median time to drug-related SGIH onset was 12.5 days (interquartile range 1-220.25 days). When patients on the related drugs present with corresponding abdominal symptoms, it is crucial to consider the differential diagnosis of SGIH despite its low incidence.

Keywords: FAERS; anticoagulant; antiplatelet; gastrointestinal intraluminal hematomas; pharmacovigilance; thrombocytopenia.