Predictors of gastrointestinal bleeding in older persons taking nonsteroidal anti-inflammatory drugs: Results from the FDA adverse events reporting system

BACKGROUND AND PURPOSE: Older adults continue to take nonsteroidal anti-inflammatory drugs (NSAIDs) to manage chronic pain. The study's purpose was to identify predictors of gastrointestinal (GI) bleeding in older adults taking NSAIDs. METHODS: A secondary analysis of the 2016 Food and Drug Administration's Adverse Events Reporting System data was conducted with 1,347 cases aged 65 years and older with an NSAID as the primary suspect for an adverse drug event (ADE). Data included age, sex, NSAID, multiple NSAID use, rivaroxaban, warfarin, clopidogrel, cardiovascular drug (proxy for cardiovascular disease), diabetes drug (proxy for diabetes mellitus), and primary adverse drug response. CONCLUSIONS: Aspirin was the primary suspect NSAID in 72.5% of cases. Rivaroxaban was taken in 67.9% of cases. Logistic regression was conducted to predict GI bleed versus other NSAID-related ADEs with age, sex, cardiovascular medication, diabetes medication, warfarin, clopidogrel, concurrent NSAID use, aspirin, and rivaroxaban as predictors. Aspirin, rivaroxaban, and concurrent NSAID were significant predictors of GI bleed. Gastrointestinal bleed risk versus other ADE risk increased by 39.77 times when taking aspirin, rivaroxaban, and another NSAIDs concurrently. IMPLICATIONS FOR PRACTICE: Results support reduced NSAID use by older adults, especially aspirin, and avoidance of rivaroxaban in older persons taking NSAIDs.