Predictors of hemorrhagic stroke in older persons taking nonsteroidal anti-inflammatory drugs: Results from the Food and Drug Administration Adverse Event Reporting System

BACKGROUND: Hemorrhagic strokes have not declined in the United States despite a decline worldwide. PURPOSE: To identify hemorrhagic stroke risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs), other medications associated with increased risk for hemorrhagic stroke, and diabetes, cardiovascular disease, gender, and age. METHODS: A post hoc design was used to examine predictors of hemorrhagic stroke for adults of age 65 years and older from the Food and Drug Administration Adverse Events Reporting System database. The initial sample consisted of all cases reported during the third quarter of 2016 and the second quarter of 2018 with an NSAID as the primary suspect for the adverse drug event (ADE). An additional 397 cases with warfarin as the primary suspect were included in the final sample (N = 3,784) to test for bias from including only NSAID as the primary ADE suspect cases. Extracted data included the primary ADE (hemorrhagic stroke or other ADE), age, gender, primary suspect drug (NSAID or warfarin), and presence of a second NSAID, rivaroxaban, warfarin, clopidogrel, antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants), inhaled corticosteroids, diabetes, or cardiovascular medications. Logistic regression was used to predict hemorrhagic stroke. RESULTS: Aspirin and warfarin increased the risk for hemorrhagic stroke by 3.458 and 3.059, respectively. Presence of an additional NSAIDs reduced the risk by 48%. IMPLICATIONS FOR PRACTICE: Hemorrhagic stroke risk specific to older adults may provide helpful estimates for practitioners as they weigh the risk benefit of prescribing aspirin as an antiplatelet therapy for older adults.