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.
Highlights
For more than two decades, the safety of fluoroquinolones (FQs) was under investigation
In the patients who developed adverse drug reactions (ADRs), a higher incidence was observed among males in both the study cohort (SC) (78.1%) and reference cohort (RC)
The incidence of ADRs was predominantly higher in the age group of 61–70 years for both the SC (24.4%) and RC (30.8%) (Table 1)
Summary
For more than two decades, the safety of fluoroquinolones (FQs) was under investigation. These commonly used antibiotics are advocated only when no alternatives are available, due to adverse effects, by recent warnings, for common conditions like uncomplicated urinary tract infections (UTIs) and acute bacterial infections of the sinus and bronchi [1]. Antibiotics 2019, 8, 104 black-box warnings which were revised over the years. They were kept in place for warning the potential risks of tendinitis, worsening of myasthenia gravis, and peripheral neuropathy. Even though FQs have great pharmacokinetic properties, there are concerns for human wellbeing
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