Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration

Sankar, Ashwini; Swanson, Kristi M.; Zhou, Jiani; Jena, Anupam B.; Ross, Joseph S.; Shah, Nilay D.; Karaca‐Mandic, Pinar

doi:10.1001/jamanetworkopen.2021.36662

Cited by 27 publications

(19 citation statements)

References 27 publications

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“…Fluoroquinolones have been recently subject to safety scrutiny and in 2018 both FDA [ 23 ] and EMA [ 24 ] issued safety warnings, which translated into a subsequent restriction or suspension of several drugs belonging to this class. The effect of these warnings is evident in our data in 2019 and it is in line with the observed change in prescribing patterns in the US following regulatory changes due to safety re-assessment of this class of antibiotics [ 25 ]. Nevertheless, we note that the use of fluoroquinolones in Piedmont was still higher than expected even in 2019, considering the reported health risks and the availability of alternatives.…”

Section: Discussionsupporting

confidence: 86%

Time-Trends of Drug-Drug Interactions among Elderly Outpatients in the Piedmont Region (Italy): A Population-Based Study

Galai

Scotti

Gilardetti

et al. 2022

IJERPH

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Adverse drug reactions (ADRs) are a major health problem in the primary care setting, particularly among the elderly population. While the high frequency of ADRs in the elderly has several causes, a major and common determinant is polypharmacy, which can in turn increase the risk of drug-drug interactions (DDIs). In this paper, we analyzed the drugs prescriptions dispensed to elderly outpatients, to assess changes in the prevalence of selected DDIs in the period 2013–2019. Overall, about 15% of the patients aged >65 years were poly-treated. Among them, a decreasing trend in prevalence was observed for the majority of DDIs during the study period. This trend was particularly noticeable for DDIs involving fluoroquinolones and vitamin K antagonists, where a sharp reduction of over 40% was observed. On the opposite, a small increase in prevalence was observed for the association of antidiabetics and beta-blocking agents and for that of clopidogrel and PPIs. While the occurrence of most of the considered DDIs among poly-treated elderly decreased over time, the prevalence of some of them is still worrying. The complexity of the national drug formularies, as well as the increased number of prescribing actors that are involved, further urges the update of DDI lists to be used to monitor drug appropriateness and reduce avoidable ADRs.

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Section: Discussionsupporting

confidence: 86%

Time-Trends of Drug-Drug Interactions among Elderly Outpatients in the Piedmont Region (Italy): A Population-Based Study

Galai

Scotti

Gilardetti

et al. 2022

IJERPH

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“…Importantly, while antimicrobial stewardship programs are currently evolving, the prescription of fluoroquinolones and third generation cephalosporins such as ceftriaxone or cefotaxime must be questioned and, if feasible, substituted for less unfavorable agents given the increasing prevalence of resistance among Enterobacterales (e.g., ESBL). This is supported by national and international safety warnings on both antibiotic classes based on potent adverse events of fluoroquinolones [ 32 , 33 , 34 ].…”

Section: Discussionmentioning

confidence: 99%

Microbial Spectrum and Antibiotic Resistance in Patients Suffering from Penetrating Crohn’s Disease

Kusan

Surat

Kelm

et al. 2022

JCM

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Intraabdominal abscess formation occurs in up to 30% of patients suffering from Crohn´s disease (CD). While international guidelines recommend a step-up approach with a combination of empiric antibiotic therapy and percutaneous drainage to delay or even avoid surgery, evidence about microbial spectrum in penetrating ileitis is sparse. We retrospectively assessed outcomes of 46 patients with terminal penetrating Ileitis where microbial diagnostics have been performed and compared microbial spectrum and antibiotic resistance profile of CD patients with patients suffering from diverticulitis with intraabdominal abscess formation. In both groups, the most frequently isolated pathogen was the gram-negative bacterium E. coli belonging to the family of Enterobacterales. However, overall Enterobacterales were significantly more often verifiable in the control group than in CD patients. Furthermore, microbial analysis showed significant differences regarding isolation of anaerobic pathogens with decreased frequency in patients with CD. Subgroup analysis of CD patients to evaluate a potential influence of immunosuppressive therapy on microbial spectrum only revealed that Enterobacterales was less frequently detected in patients treated with steroids. Immunosuppressive therapy did not show any impact on all other groups of pathogens and did not change antibiotic resistance profile of CD patients. In conclusion, we were able to demonstrate that the microbial spectrum of CD patients does differ only for some pathogen species without increased rate of antibiotic resistance. However, the empiric antibiotic therapy for CD-associated intra-abdominal abscess remains challenging since different points such as local epidemiological and microbiological data, individual patient risk factors, severity of infection, and therapy algorithm including non-surgical and surgical therapy options should be considered before therapeutical decisions are made.

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“…Consequently, the resulting FQ–protein–DNA adducts trigger the SOS response and cell death by a mechanism that probably involves processing of the cleavage complex to reveal the DNA breaks 9 . FQs remain remarkably effective, but side effects 10 have restricted FQ use in the United States by a black box warning 11 and there is widespread resistance 1 , prompting the search for new chemical leads. Of these, the most advanced clinically are ‘novel bacterial topoisomerase inhibitors’ (NBTIs) exemplified by gepotidacin, which is currently under investigation in two phase III trials for infections caused by Gram-negative bacteria 12 , 13 , and spiropyrimidinediones such as zoliflodacin 14 which is currently in phase III clinical trials for treatment of patients with uncomplicated gonorrhoea.…”

Section: Mainmentioning

confidence: 99%

Molecular mechanism of topoisomerase poisoning by the peptide antibiotic albicidin

et al. 2023

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The peptide antibiotic albicidin is a DNA topoisomerase inhibitor with low-nanomolar bactericidal activity towards fluoroquinolone-resistant Gram-negative pathogens. However, its mode of action is poorly understood. We determined a 2.6 Å resolution cryoelectron microscopy structure of a ternary complex between Escherichia coli topoisomerase DNA gyrase, a 217 bp double-stranded DNA fragment and albicidin. Albicidin employs a dual binding mechanism where one end of the molecule obstructs the crucial gyrase dimer interface, while the other intercalates between the fragments of cleaved DNA substrate. Thus, albicidin efficiently locks DNA gyrase, preventing it from religating DNA and completing its catalytic cycle. Two additional structures of this trapped state were determined using synthetic albicidin analogues that demonstrate improved solubility, and activity against a range of gyrase variants and E. coli topoisomerase IV. The extraordinary promiscuity of the DNA-intercalating region of albicidins and their excellent performance against fluoroquinolone-resistant bacteria holds great promise for the development of last-resort antibiotics.

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Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration

Abstract: This cross-sectional study assesses the pattern of antibiotics prescribing for sinusitis, bronchitis, and uncomplicated urinary tract infection before and after US Food and Drug Administration warnings.

Cited by 27 publications

References 27 publications

Time-Trends of Drug-Drug Interactions among Elderly Outpatients in the Piedmont Region (Italy): A Population-Based Study

Time-Trends of Drug-Drug Interactions among Elderly Outpatients in the Piedmont Region (Italy): A Population-Based Study

Microbial Spectrum and Antibiotic Resistance in Patients Suffering from Penetrating Crohn’s Disease

Molecular mechanism of topoisomerase poisoning by the peptide antibiotic albicidin

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