(SLB-012) An Active-Comparator Restricted Disproportionality Analysis of Fluoroquinolone and the Risk of Panic Attacks

Background: Fluoroquinolones (FQs) are broad-spectrum antibiotics that are often prescribed for treating a variety of bacterial infections in humans, including respiratory, gastrointestinal, and urinary tract infections. Given the risk of severe side effects involving the central nervous system (CNS), panic attacks—characterized by intense, sudden anxiety and distress—are frequently reported but underexplored potential side effects of FQs. We conducted an active comparator disproportionality analysis determined whether FQs versus non-FQs are associated with a higher risk of panic attacks.

Objectives: To assess the association between FQs and the risk of panic attacks compared to azithromycin and sulfamethoxazole-trimethoprim (SMX-TMP) using data from the FDA Adverse Event Reporting System (FAERS).

Methods: Design and Setting: An active comparator-restricted disproportionality analysis of FAERS data (2015Q3–2023Q3) using MedDRA-v27.1 preferred terms, with analysis restricted to primary suspect cases.
Exposures and Outcome: FQs was compared to azithromycin and SMX-TMP as active comparators. The primary outcome was the frequency of panic attacks reports.
Statistical Analysis: We calculated the Reporting Odds Ratios (RORs) adjusting for age, sex, urinary tract infection, and respiratory tract infection.

Results: A total of 114,130 individual case safety reports (ICSRs) were analyzed: 82,632 reports for FQs (72.4%), 21,431 for azithromycin (18.8 %), and 10,067 for SMX TMP (8.8%). Disproportionality analyses showed that reports of fluoroquinolone-associated panic attacks were 6- to 12-fold higher than those linked to azithromycin (1,022/82,632 [1.24%] vs. 40/21,431[0.19%], aROR 5.73, 95% CI [4.16 to 7.88]) and sulfamethoxazole-trimethoprim (1,022/82,632 [1.24%] vs. 10/10,067[0.10%], aROR 12.20, 95% CI [ 6.54 to 22.75]).

Conclusions: Our pharmacovigilance study suggested FQs were associated with an increased risk of panic attacks compared to other non-FQ antibiotics, including azithromycin and sulfamethoxazole-trimethoprim. The findings may clarify the association between FQs and panic attacks to further inform larger pharmacoepidemiology studies to guide clinical decision-making and enhance patient safety when treating bacterial infections with FQs.