Carpal Tunnel Syndrome Attributed to Medication Use: A Pharmacovigilance Study.
This retrospective pharmacovigilance study examined whether specific drugs are disproportionately associated with carpal tunnel syndrome (CTS) reports in the FDA Adverse Event Reporting System (FAERS) database between October 2003 and September 2024. Using OpenVigil 2.1, researchers applied disproportionality analysis—primarily reporting odds ratios (RORs)—supplemented by Bayesian confidence propagation neural network algorithms to identify significant drug-CTS signals. Out of nearly 13 million adverse event reports, 6,837 (0.05%) involved CTS, with female patients comprising 69.5% of cases and a mean age of 57 years. Ten drugs showed strong, statistically significant associations with CTS reports: enzyme replacement therapies (idursulfase, galsulfase, laronidase), the growth hormone-releasing factor analog tesamorelin, the aromatase inhibitor anastrozole, bisphosphonates (alendronic acid, alendronate), gamma-hydroxybutyric acid (GHB), the COX-2 inhibitor rofecoxib, and the transthyretin stabilizer tafamidis. The study's key limitations include its reliance on spontaneous reports (subject to underreporting, reporting bias, and confounding), an inability to establish causality, and lack of exposure-denominator data. The authors conclude that clinicians should be alert to CTS symptoms in patients prescribed these medications.
Why this grade: While the study uses a large human adverse-event database, it is a retrospective disproportionality analysis of spontaneous reports, which cannot establish causality, is prone to reporting and confounding biases, and lacks denominator data on drug exposure—limiting the strength of evidence to the "limited-human" tier.
Objective Carpal tunnel syndrome (CTS) is a prevalent compression neuropathy with multiple well-documented mechanical and systemic risk factors. However, the role of pharmacological agents in the development of CTS remains underexplored. This study aims to identify drugs disproportionately associated with CTS reports using data from the Food and Drug Administration Adverse Event Reporting System (FAERS). Methods A retrospective pharmacovigilance analysis was conducted using OpenVigil 2.1 to evaluate adverse event (AE) reports of CTS from the FAERS database from October 2003 to September 2024. Only drugs identified as the primary suspect in at least 10 AE reports were included. Disproportionality analysis, including reporting odds ratios (RORs), was used to assess associations between CTS and specific drugs. Positive signals were validated using Bayesian confidence propagation neural network algorithms, with drugs having ROR ≥10 and significant Bayesian confidence intervals (IC025 > 0) considered strongly associated with CTS. Results Of 12,929,504 AEs reported during the study period, 6,837 (0.05%) involved CTS. Female patients comprised 69.5% of CTS cases, with a mean age of 57.0±14.9 years. Ten drugs were found to have significant overreporting of CTS, including idursulfase (ROR=51.2, 95% CI=39.0-67.2), galsulfase (ROR=26.8, 95% CI=17.2-41.7), laronidase (ROR=20.9, 95% CI=14.4-30.3), tesamorelin (ROR=20.7, 95% CI=13.7-31.3), anastrozole (ROR=20.6, 95% CI=17.0-24.9), alendronic acid (ROR=17.1, 95% CI=14.5-20.1), gamma-hydroxybutyric acid (GHB) (ROR=16.3, 95% CI=9.6-27.6), rofecoxib (ROR=16.1, 95% CI=14.3-18.2), alendronate (ROR=12.9, 95% CI=11.0-15.2), and tafamidis (ROR=12.0, 95% CI=9.2-15.7). Conclusions Several drugs were disproportionately associated with CTS in the FAERS database, including enzyme replacement therapies (ERTs), aromatase inhibitors, bisphosphonates, growth hormone (GH)-releasing factor analogs, GHB, rofecoxib, and tafamidis. These findings highlight the critical need for increased vigilance and monitoring of new-onset or worsening CTS in high-risk populations prescribed the aforementioned medications. Clinicians should carefully scrutinize pharmacological history when evaluating patients in this context.
Educational summary of published research — not medical advice. License: cc by. Full text is shown only where licensing permits.