ABSTRACT
Background
Acetylsalicylic acid (Aspirin), one of the oldest medicines, is widely used in various clinical fields. However, numerous adverse events (AEs) have been reported. In this study, we aimed to investigate adverse drug reactions (ADRs) of aspirin using real-worlddata from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
Methods
We assessed the disproportionality of aspirin-related AEs by calculating measures such as reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagationneural network (BCPNN), and Gamma-Poisson Shrinker (GPS).
Results
Out of 7,510,564 casereports in the FAERS database, 18644 reports of aspirin as the ‘primary suspected (PS)’ AEs were recorded. Disproportionality analyses identified 493 aspirin-related preferred terms (PTs) across 25 organ systems. Notably, unexpected significant AEs such as pallor (p=5.66E–33), dependence (p=6.45E–67), and compartment syndrome (p=1.95E–28) were observed, which were not mentioned in the drug’s instructions.
Conclusion
Our findings align with clinical observations, highlighting potential new and unexpected ADR signals associated with aspirin. Further prospective clinical studies are necessary to confirm and elucidate the relationship between aspirin and these ADRs. This study offers a fresh and unique perspective for studying drug-AEs.
Acknowledgments
This study was performed using the FDA Adverse Event Reporting System (FAERS) source that was provided by the FDA. The information, results, or interpretation of the current study do not represent any opinion of the FDA.
We thank Zhao’s team (Official WeChat Account: SCIPhD) of Sheng Xin Zhu Shou
for their suggestions and language editing of this article.
Declaration of interest
The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Data sharing statement
The data included in this study are available on the request from the corresponding author or the first author.
Ethics statement
This manuscript only analyzed publicly available data, which is nonsensitive data, therefore ethics does not apply. Additionally, the database link is cited in the article and is acknowledged in the acknowledgments section.
Supplemental data
Supplemental data for this article can be accessed online at https://doi.org/10.1080/17425255.2023.2235267.