Hypoglycaemia associated with Fluoroquinolone: A pharmacovigilance analysis from 2014 to 2023 based on the FDA Adverse Event Reporting System (FAERS)

Dan Li ¹ Zhang Yuan ¹ Yuqi , Wang ¹ Lei Cheng ¹ Xiaodan Zhou ¹ Jia Chen ¹ Guoweng , Feng ² Yaling Chen ¹ Yun Chen ¹ Zixue Xuan ^1,3 Li Chen ^4,5*

• ¹ Zhejiang Provincial People' s Hospital Bijie Hospital, Zhejiang, China
• ² Department of Pharmacy, Affiliated Hospital of Chengdu University, Chengdu, China
• ³ Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, China
• ⁴ West China Second University Hospital, Sichuan University, Chengdu, China
• ⁵ Key Laboratory of Birth Defects and Related Diseases of Women and Children, West China Second University Hospital, Sichuan University, Chengdu, Sichuan Province, China

Objectives: With the increasing use of fluoroquinolones (FQs) for anti-infective therapy, the adverse effects (AEs) caused by their collateral effects pose a key challenge in their clinical application.Hypoglycemic AEs are a type of AE linked to FQs and are commonly observed in real-world settings.Our objective is to provide a comprehensive analysis and summary of hypoglycemic AEs associated with FQs, specifically focusing on moxifloxacin (MOX), ciprofloxacin (CPR), and levofloxacin (LEV).Methods: Disproportionality analysis was employed to assess the strength of association between fluoroquinolones (FQs) related hypoglycemia and potential safety signals using data from the FDA's adverse event reporting system (FAERS), covering quarters from 2014 Q1 to 2023 Q4. We utilized a standardized MedDRA query (SMQ) at the preferred term (PT) level to retrieve AE data from FAERS reports. Following the removal of duplicate reports, disproportionality analysis was conducted to identify potential safety signals associated with FQs-related hypoglycemia by calculating reporting odds ratios (ROR). Additionally, clinical characteristics, onset timing, oral and intravenous administrations, serious outcomes related to FQ-associated hypoglycemia were further analyzed to provide a comprehensive understanding of the safety profile.Results: A total of 24,2509 AEs reports led by FQs were detected, of which 16,306 induced hypoglycaemia signals. Among these cases, a higher percentage was represented by female compared to male (52.55% vs.36.07%). The demographic analysis indicated that FQ-induced hypoglycemia were mainly concentrated in patients aged 18 ~ 64 years, the mean age of patients ranged from 51.14 to 57.39 years. Moreover, CPR had the most cases of hypoglycemia and related conditions (ROR 99.02, PRR 98.15, IC 35.66, EBGM 96.79) while LEV was relatively weakly associated with hypoglycemic (ROR 82.78, PRR 82.45, IC 27.89, EBGM 81.02). This study showed that all three FQs detected positive signals of hypoglycaemia in the 1 week. Oral fluoroquinolone-induced hypoglycaemia had a stronger signal strength than intravenous administration. As for the dead and disability rate of hypoglycaemia, MOX had the most cases of severe adverse drug events.Conclusions: FQ-induced hypoglycemia tends to occur early and can have serious consequences. Our preliminary findings can provide enhanced understanding and monitoring of potential hypoglycemia linked to FQ treatment.