Drugs Associated With Floppy Iris Syndrome: A Real-World Population-Based Study

Area of Science:

• Ophthalmology
• Pharmacovigilance
• Drug Safety

Background:

• Intraoperative floppy iris syndrome (IFIS) increases cataract surgery complications, especially in females.
• No comprehensive pharmacovigilance studies have fully examined FDA-approved drugs for IFIS association or sex differences.
• Identifying IFIS risk factors aids surgeons in managing high-risk patients.

Purpose of the Study:

• To conduct a pharmacovigilance study on FDA-approved drugs and their association with IFIS.
• To investigate potential sex differences in IFIS development.
• To inform surgical risk stratification and management strategies for IFIS.

Main Methods:

• Retrospective pharmacovigilance clinical cohort study analyzing FDA Adverse Event Reporting System data (October 2003–March 2024).
• Utilized disproportionality metrics (RORs, PRRs) to identify adverse reaction signals.
• Conducted subgroup analyses based on sex.

Main Results:

• Out of 12,345,128 reports, 649 (0.0053%) involved IFIS.
• Highest IFIS disproportionality observed with imipramine, tamsulosin, and chlorpromazine.
• Over-reported drug classes include α1-blockers, tricyclic antidepressants, and atypical antipsychotics.
• Brinzolamide and salbutamol showed disproportionate IFIS association in females, not males.

Conclusions:

• Tricyclic antidepressants, alongside α1-blockers and atypical antipsychotics, are significantly associated with IFIS.
• Significant sex differences in IFIS drug associations were identified.
• Findings are critical for perioperative counseling and surgical planning in cataract surgery.