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The following is a summary of “Drugs Associated with Floppy Iris Syndrome: A Real-World Population-Based Study,” published in the March 2025 issue of American Journal of Ophthalmology by Lakhani et al. 

Intraoperative floppy iris syndrome (IFIS) boosts the likelihood of serious surgical complications and vision problems during cataract surgery, especially in women.  

Researchers conducted a retrospective study to examine the association between IFIS and all Food and Drug Administration (FDA)-approved drugs while assessing potential sex differences.  

They analyzed IFIS cases reported to the Food and Drug Administration Adverse Event Reporting System (FAERS) from October 2003 to March 2024 using OpenVigil 2.1. Disproportionality metrics, including reporting odds ratios (RORs), proportional reporting ratios (PRRs), and relative risk reductions (RRRs), identified positive adverse reaction signals (n>2, χ² >4, PRR>2) compared to all other drugs. Subgroup analyses were performed based on sex.  

The results showed that out of 1,23,451,28 adverse events (AE) reports, 649 cases (0.0053%) involved IFIS. Healthcare professionals reported most cases (75.75%, n=203), followed by consumers (12.69%, n=34) and unknown sources (11.57%, n=31). The highest disproportionality for IFIS was observed with imipramine (ROR=251.66, 95% confidence interval [CI]=157.53-402.02), tamsulosin (ROR=171.44, 95% CI=143.12-205.36), and chlorpromazine (ROR=91.30, 95% CI=49.91-167.03) [all P <0.0001, IC₀₂₅ >0 (Lower Limit of the 95% Credibility Interval for the Information Component)]. Over-reported drug classes included α1-blockers, tricyclic antidepressants, atypical antipsychotics, carbonic anhydrase inhibitors, corticosteroids, 5α-reductase inhibitors, β-blockers, prostaglandin analogs, and β2-agonists. Among females, brinzolamide (ROR=409.63, 95% CI=196.78-852.73) and salbutamol (ROR=67.12, 95% CI=28.37-158.80) showed a significant association with IFIS (both P <0.0001, IC₀₂₅ >0), whereas no such associations were identified in males.  

Investigators concluded that tricyclic antidepressants, along with α1-blockers and atypical antipsychotics, enhanced the risk of IFIS, particularly showing sex-based variations. 

Source: ajo.com/article/S0002-9394(25)00139-4/abstract