Drug-Associated Tendinopathies and Ligament Disorders: Results from a Retrospective Pharmacovigilance Study Using Disproportionality Analysis.

Abstract

Background: Tendinopathies and ligament disorders are significant musculoskeletal adverse events associated with various drugs, leading to restricted mobility and reduced quality of life. Although certain drug classes such as fluoroquinolones and corticosteroids have established links to these conditions, there is limited research on other potential drug associations. This study aimed to comprehensively evaluate drugs associated with tendinopathies and ligament disorders using data from the USFDA Adverse Event Reporting System (AERS). Methods: A retrospective pharmacovigilance study utilizing spontaneous reports from the USFDA AERS database between March 2004 and June 2024 was conducted. The Standardized Medical Dictionary for Regulatory Activities (MedDRA) query "Tendinopathies and ligament disorders" and relevant Preferred Terms were used to identify cases. Disproportionality analysis was performed using both frequentist and Bayesian methods. Subgroup analyses were conducted by age, gender, and clinical outcomes. Results: Out of 29 153 222 reports, 40 485 unique reports were included, with 6641 related to tendon rupture and 2121 to ligament rupture. Fluoroquinolones, corticosteroids, lipid-modifying agents, immunosuppressants, and bisphosphonates were confirmed to have strong associations with tendon and ligament disorders. Emergent signals were identified for anti-inflammatory drugs, and various other drugs, including vaccines. Hospitalization rates were significantly higher in cases of tendon rupture compared to ligament rupture (P < .0001). Conclusion: This study confirms established drug associations and identifies new signals for tendinopathies and ligament disorders. Continued pharmacovigilance is necessary to validate these findings and enhance our understanding of drug-induced musculoskeletal disorders.