Compartment syndrome associations with drugs: a pharmacovigilance study of the FDA adverse event reporting system (FAERS)

ABSTRACT

Background

Compartment syndrome is an uncommon but life-threatening condition. No study has comprehensively compared compartment syndrome (CS) association with available drugs. The objective of this study was to estimate the association between CS and drugs using the FDA Adverse Event Report System (FAERS).

Research design and methods

FAERS reports from the first quarter of 2004 to the third quarter of 2023 were analyzed. The Medical Dictionary for Regulatory Activities (MedDRA) was used to identify CS cases. Reporting odds ratio (ROR), corresponding to 95% confidence intervals (95% CI) were calculated to detect a positive signal.

Results

A total of 2197 reports were considered in the study after the inclusion criteria were applied. Totally 100 drugs were found to be associated with CS. The median time for drug-associated CS was 45 days.

Conclusions

By analyzing the FAERS database, the study revealed that certain drugs are significantly associated with compartment syndrome. Further studies are needed to verify whether these drugs are associated with such a risk.

KEYWORDS:

• Compartment syndrome
• pharmacovigilance
• adverse drug events
• disproportionality analysis
• FAERS

Declaration of interest

The authors have no 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. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Study concept and design: Wenqiang Kong, Xueting Yang and Jie Wan; Statistical analysis: Wenqiang Kong; Interpretation of data: Wenqiang Kong; Drafting of the manuscript: Yunfeng Shu; Critical revision of the manuscript for important intellectual content: All authors; Study supervision: Juan Tang.

Additional information

Funding

This paper was not funded.