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

1
Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India
2
Manipal Center for Infectious Diseases, Prasanna School of Public Health, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India
3
Department of Medicine, Kasturba Medical College and Hospital, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India
*
Author to whom correspondence should be addressed.
Contributed equally.
Antibiotics 2019, 8(3), 104; https://doi.org/10.3390/antibiotics8030104
Received: 2 May 2019 / Revised: 18 July 2019 / Accepted: 24 July 2019 / Published: 27 July 2019
(This article belongs to the Section Antibiotics Use and Antimicrobial Stewardship)
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. View Full-Text
Keywords: adverse effects; drug safety; FDA; fluoroquinolones adverse effects; drug safety; FDA; fluoroquinolones
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Mathews, B.; Thalody, A.A.; Miraj, S.S.; Kunhikatta, V.; Rao, M.; Saravu, K. Adverse Effects of Fluoroquinolones: A Retrospective Cohort Study in a South Indian Tertiary Healthcare Facility. Antibiotics 2019, 8, 104.

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