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

Benitta Mathews, Ashley Ann Thalody, Sonal Sekhar Miraj, Vijayanarayana Kunhikatta, Mahadev Rao, Kavitha Saravu, Benitta Mathews, Ashley Ann Thalody, Sonal Sekhar Miraj, Vijayanarayana Kunhikatta, Mahadev Rao, Kavitha Saravu

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.

Keywords: FDA; adverse effects; drug safety; fluoroquinolones.

Conflict of interest statement

The authors declare no conflicts of interest.

Figures

Figure 1
Figure 1
Number of fluoroquinolone (FQ) prescriptions (N = 498). This chart represents different FQs prescribed in the study population with the number of prescriptions for each FQ, indicating that ciprofloxacin (CFX) has the highest number of prescriptions followed by levofloxacin (LFX), ofloxacin (OFX), moxifloxacin (MFX), and norfloxacin (NFX).
Figure 2
Figure 2
Number of different fluoroquinolone prescriptions with their route of administration. This chart represents the three major types of FQs (CFX, LFX, OFX) prescribed in the study population with their route of administration, indicating that the oral route was the most commonly prescribed for all the FQs. IV—intravenous.
Figure 3
Figure 3
Incidence of patients who developed adverse drug reactions (ADRs) among both cohorts: (a) incidence of patients who developed ADRs among the study cohort, indicating the highest incidence of 172 (58%) with LFX; (b) incidence of patients who developed ADRs among the reference cohort, indicating the highest incidence of 173 (46.2%) with amoxicillin–clavulanic acid.
Figure 3
Figure 3
Incidence of patients who developed adverse drug reactions (ADRs) among both cohorts: (a) incidence of patients who developed ADRs among the study cohort, indicating the highest incidence of 172 (58%) with LFX; (b) incidence of patients who developed ADRs among the reference cohort, indicating the highest incidence of 173 (46.2%) with amoxicillin–clavulanic acid.
Figure 4
Figure 4
Number of patients who developed ADRs based on the route of administration of different fluoroquinolones. This chart shows the incidence of patients who developed ADRs after the administration of different types of FQs via different routes (IV and oral), indicating the highest incidence with IV LFX administrations.
Figure 5
Figure 5
Number of patients who developed ADRs based on the duration of use of antibiotics. This chart shows the incidence of patients who developed ADRs based on the duration of use of both FQs and other antibiotics. Duration of the use of the antibiotic was categorized as “less than or equal to one day” (≤1), “up to one week” (>1 to ≤7), “up to one month” (>7 to ≤30), and “more than one month” (>30).
Figure 6
Figure 6
Receiver operating characteristic (ROC) curve of the developed ADR prediction model. The ROC curve analysis of the developed prediction model exhibited good discriminating power for the developed prediction model with area under the curve (AUC) = 0.647 at p < 0.001.
Figure 7
Figure 7
Residual plot of the developed ADR prediction model. The model exhibited a relatively equal distribution of points above and below at the horizontal line at residuals = 0, indicating non-violation of the assumption of linearity and equal variance of the regression model.
Figure 8
Figure 8
Study flow chart.

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