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.