Sex and Age Differences in Suspected Bleeding Reporting With Acetyl Salicylic Acid: A Descriptive Study in the Global Pharmacovigilance Database, Vigibase

Objective

The present study was performed to investigate putative sex differences in the reporting of acetyl salicylic acid (ASA)–related bleeding in the global pharmacovigilance database.

Methods

Using Vigibase, the global pharmacovigilance database, all bleeding reports with ASA between January 1, 2008, and December 31, 2021, in adults were included. The main bleeding locations with ASA were compared in men versus women. A secondary objective was to analyze possible age differences. Results are presented as reporting odds ratios (RORs) with their 95% confidence interval.

Results

Among 29 034 bleeding with ASA, the most frequent were gastrointestinal (41.2%), neurological (21.3%), and nasal (13.6%). Higher ROR values were found in men for all bleeding in general (ROR = 1.56 [1.51–1.61]) but also for gastrointestinal, neurological, nasal, and renal locations. Similar trends were found for “serious” reports (except for gastrointestinal bleeding). Neurological fatal reports were more frequently reported in men. These sex differences were also found in all the age categories. Higher ROR values were found in patients from 65 years.

Conclusion

The risk of total, “serious,” and fatal bleeding reporting with ASA was higher in men than in women and after 65 years. Similar conclusions can be made for the most frequent locations of ASA-associated bleeding: gastrointestinal followed by neurological and nasal ones.