Fluoroquinolone antibiotics: safety of use by the example of ciprofloxacin

Due  to repeated reports of adverse effects with the  use  of fluoroquinolone antibiotics,  these drugs become  over  and  over  again the  object of the  close  attention of pharmacovigilance  specialists and  health care  specialists. The aim: to study the  frequency and  the  nature of adverse reactions associated with the  use  of ciprofloxacin, based  on the  analysis of the  spontaneous reports received by  the  Russian pharmacovigilance service. Materials and  Methods: A retrospective analysis of the  spontaneous reports of ciprofloxacin was conducted on the  data-base «Pharmacovigilance» of the  automated information system of Roszdravnadzor from 2008 to 2018. Results: 3403  adverse reactions that occurred in 2083  patients using ciprofloxacin were recorded. The  most frequently developed reactions were  from skin and  subcutaneous tissues (37.3 %), general disorders and  disorders at the  injection site (21.1 %), gastrointestinal tract reactions (14.9 %). More than a one third of the  reports contained information about serious adverse reactions. Unexpected reactions were identified as not  recorded in the  instructions for the medical use of ciprofloxacin: bradycardia, atrial arrhythmia, cyanosis, increased blood pressure. Conclusions: fluoroquinolone antibiotics with proven efficacy and years of experience in clinical use, continue to be drugs whose  safety requires constant monitoring. The  results of the  study confirmed the  possibility of detecting a wide  range of the  adverse reactions using the  method of spontaneous reports. Regulatory authorities of the  Russian Federation should recommend to registration certificate holders to include the  information of adverse reactions of ciprofloxacin that were registered in the  post-marketing period in the  instructions for medical use.

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