Consistent with the findings of the Food and Drug Administration (FDA) Expert Council, the fluoroquinolone (FH) antimicrobial guidelines require more stringent warnings about the risks of serious adverse events during treatment, including tendonitis. and cases of tendon rupture, QT prolongation and the development of peripheral neuropathy.

FDA's Antimicrobial Drugs Advisory Committee (ADMAC) and the Drug Safety and Risk Management Advisory Committee have joined together to discuss the use of fluoroquinolones for the treatment of acute bacterial rhinosinusitis, exacerbation COPD and uncomplicated urinary tract infections (UTI).

Currently, the instructions to the FC contain warnings on the risks of tendinitis, tendon rupture, damage to the central nervous system, development of peripheral polyneuropathy, exacerbation of myasthenia gravis, prolongation of the QT interval and development of potentially fatal arrhythmias (including torsades de pointes), phototoxicity and hypersensitivity reactions. However, members of the advisory committee insist on introducing stricter warnings in the instructions, even in some cases with the status of "black box warning" (by placing the so-called "black warning" on the package with the drug).

The members of the advisory committee also voted overwhelmingly that the benefits and risks of using systemic PX do not support the current indications listed in the instructions for use of this group of antibiotics for acute bacterial rhinosinusitis ( unanimously), exacerbation of COPD (2 votes in favor, 18 against), 1 "abstained") and UTI simple (1 "for", 20 "against").

Currently, ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin and gemifloxacin are used by approved PF for one or more of the indications listed above.

Adverse events considered by experts have been reported in a significant number of patients since FDA approval of FH, and many believe that FDA should modify and update the instructions regularly based on new safety information.

The Infectious Diseases Society of America (IDSA) recommends PX as a second-line drug to treat patients with allergic reactions to other antibiotics, if the patient develops ineffective first-line drugs, and if the patient has the infection is caused by pathogens resistant to first row antimicrobial drugs.

The therapeutic benefit of using FP in acute bacterial rhinosinusitis and in mild exacerbation of COPD is, at best, very moderate.

In normal clinical practice, it is extremely difficult to distinguish between patients with viral and bacterial sinusitis. Even in studies where the diagnosis of acute bacterial sinusitis was very likely, the effect of antibiotic treatment was generally weak, and a large proportion of patients receiving placebo had a favorable clinical response to treatment.

A meta-analysis of 9 randomized trials in patients with acute bacterial rhinosinusitis (n = 2547) did not identify the group of patients for whom antibiotic therapy would be most useful.

The reviews and meta-analyzes currently published raise the question of the benefits of prescribing antibiotics for acute bacterial rhinosinusitis, and the effect of treatment is considered to be very moderate.

IDSA practice guidelines state that antimicrobial therapy should only be given to patients with more severe symptoms who are more likely to have a bacterial etiology of acute sinusitis, and beta-lactams should be preferred to respiratory fluoroquinolones.

With a mild exacerbation of COPD, the effectiveness of antibiotics, at best, is very moderate. With moderate to severe exacerbations of COPD, the effect of using antibiotics is obvious, antimicrobials are recommended for these patients (they often receive treatment in the hospital).

Two literature reviews indicate that antibiotics are effective in treating bacterial exacerbations of COPD in patients with moderate to severe exacerbations.

The American Thoracic Society and European Respiratory Society clinical guidelines for the management of COPD patients recommend antibiotic therapy for outpatients based on the severity and severity of symptoms.

According to the clinical guidelines for the treatment of COPD exacerbations published by the American College of Physicians, patients with a mild variant of COPD exacerbation do not have statistically significant differences between patients who received antibiotics and those who received the placebo.

According to the results of placebo-controlled studies, antibiotic therapy for uncomplicated urinary tract infections is effective for the microbiological eradication of causally significant pathogens and the relief of symptoms. In a study where ibuprofen was used as a control, the use of antibiotics was effective for microbiological eradication, but in the two treatment groups, the frequency of symptom resolution was the same.

From the point of view of recommendations, it is for this indication that fluoroquinolones are most often used incorrectly. According to expert advice, it is necessary to revise the instructions for drugs to make changes, as this applies not only to side effects, but also to the fact that we are exposing these drugs to patients who should not be given this group of antibiotics in all cases. In addition, doctors should keep fluoroquinolones for other indications, which in most cases are much more serious than simple urinary tract infections.