A real-world data analysis of acetylsalicylic acid in FDA Adverse Event Reporting System (FAERS) database

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.

KEYWORDS:

• Acetylsalicylic acid
• Aspirin
• Real-world data analysis
• Adverse event
• Adverse drug reaction

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.

Additional information

Funding

This paper was funded by the Natural Science Foundation of Xiamen, China (granted No. 3502Z20227155) and the self-funded Scientific Research Project of People’s Hospital of Jiuquan City, Gansu, China.