Analysis of adverse reactions associated with use of fluoroquinolones - a retrospective study

  • C Stalin Patient Safety - Pharmacovigilance Associate, Pharmacovigilance Programme of India (PVPI), National Coordination Centre, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India
  • R Sivagami Coordinator, Adverse events Monitoring Centre, Govt. Stanley Medical College, Chennai, Tamil Nadu, India
  • T Lakshmi Prasanna Patient Safety - Pharmacovigilance Associate, Pharmacovigilance Programme of India (PVPI), National Coordination Centre, Indian Pharmacopoeia Commission, Ghaziabad, Uttar Pradesh, India
Keywords: Fluoroquinolones, spontaneous reporting, drug safety, adverse reactions, retrospective study

Abstract

Fluoroquinolones are the most commonly prescribed antibiotics in infections like respiratory tract infections, urinary tract infections. Serious adverse reactions (ADR) reported with certain drugs of this class resulted in withdrawal or restriction to its use. Spontaneous reporting of ADRs has placed a major role in identifying these issues. The present study was aimed to analyze the pattern of ADRs implicated to fluoroquinolone in an ADR monitoring Centre through spontaneous reporting. A total of 24 ADRs associated with the use of fluoroquinolones were reported during the evaluation period. Upon evaluation of the patient characteristics in the reported ADRs, more reports were in females (54.16%). Fluoroquinolone antibiotic most commonly implicated in the reactions included ciprofloxacin (62.5%) followed by levofloxacin (29.1%) and ofloxacin (8.3%). Among the severe reactions (n = 5), the most commonly involved system organ class was skin and appendages. Mild and Moderate reactions involved Neurological and Gastrointestinal disorders. In 83%, the reaction was considered to be preventable. Periodic evaluation of ADR is very essential in a hospital set up and it can complement institutional risk management strategies as well as drug safety evaluation.

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Analysis of adverse reactions associated with use of fluoroquinolones
Published
2019-12-15
How to Cite
Stalin, C., Sivagami, R., & Lakshmi Prasanna, T. (2019). Analysis of adverse reactions associated with use of fluoroquinolones - a retrospective study. Journal of Basic Pharmacology and Toxicology, 3(2), 21-25. Retrieved from http://scigreen.com/index.php/JBPT/article/view/62
Section
Original Research Articles