Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility

Abstract

The Food and Drug Administration (FDA) safety review revealed that the use of fluoroquinolones (FQs) is linked with disabling and potentially permanent serious adverse effects. These adverse effects compromise the tendons, muscles, joints, nerves, and central nervous system of the human body. The purpose of the study was to investigate the incidence and risk factors for adverse drug reactions (ADRs) caused by FQs in comparison with other antibiotics used. A retrospective cohort study was conducted over seven months in Kasturba Medical College Hospital, Manipal, India. Patients who were prescribed with FQs were selected as the study cohort (SC; n = 482), and those without FQs were the reference cohort (RC; n = 318). The results showed that 8.5% (41) of patients developed ADRs in the SC, whereas 4.1% (13) of patients developed ADRs in the RC. With oral and parenteral routes of administration, almost a similar number of ADRs were observed. Levofloxacin caused the highest number of ADRs reported, especially with the 750-mg dose. Based on a multiple logistic regression model, FQ use (odds ratio (OR): 2.27; 95% confidence interval (CI): 1.18–4.39; p = 0.015) and concomitant steroid use (OR: 3.19; 95% CI: 1.31–7.79; p = 0.011) were identified as independent risk factors for the development of ADRs among antibiotics users, whereas age was found to be protective (OR: 0.98; 95% CI: 0.97–1.00; p = 0.047). The study found a higher incidence of ADRs related to FQs compared to other antibiotics. The study concludes a harmful association between FQ use and the development of ADRs. Moreover, FQs are not safe compared to other antibiotics. Hence, the use of FQs should be limited to the conditions where no other alternatives are available.

Pharmacists’ Knowledge, Attitude and Practice Regarding the Dispensing of Antibiotics without Prescription in Tanzania: An Explorative Cross-Sectional Study

“…The WHO has already reported the resistance of penicillins and fluoroquinolones in several countries [ 30 ]. The use of fluoroquinolones may be associated with adverse events compared to other antibiotics [ 31 ]. Besides, fluoroquinolones should be reserved for treatment of serious and potentially life-threatening infections and not for folks walking in to a community pharmacy.…”

Effect of ciprofloxacin vs levofloxacin on QTc‐interval and dysglycemia in diabetic and non‐diabetic patients

“…These significant changes in electrolytes and liver enzymes may be the risk factor for developing QTc prolongation after fluoroquinolone administration in this study. Although fluoroquinolones are safe, clinicians should be careful with electrolyte imbalance or cardiac disease patients to avoid any cardiovascular problem 46 . Fluoroquinolones‐induced QTc prolongation was more likely with risk factors as electrolyte disturbance and hepatic dysfunction 41,47 .…”

“…According to a retrospective study by Mathews and Thalody (2019), they observed that the use of fluoroquinolone in diabetic patients could develop hyperglycemia. 46 In addition, the results of the present study revealed that 34% and 44% of non-diabetic patients had hyperglycemia events, 72 hours after the first dose in ciprofloxacin and levofloxacin, respectively. This is in accordance with another study reporting that the highest hyperglycemia event was found with levofloxacin (70%), followed by ciprofloxacin and moxifloxacin (39% and 33.3% respectively).…”

How Safe are Fluoroquinolones for Diabetic Patients? A Systematic Review of Dysglycemic and Neuropathic Effects of Fluoroquinolones

“…There have been some unfavorable responses in studies on fluoroquinolones during the final phases of clinical trials. 7 Most of these trials have reported adverse effects of fluoroquinolone on the hepatic system, central nervous system, gastrointestinal tract, skin, and musculoskeletal system. 8 Modification of fluoroquinolone structures has also been found to have adverse drug reactions that can cause dysglycemia and neuropathy.…”