FDA and the safe and appropriate antibiotic use of fluoroquinolones

doi:10.1016/S1473-3099(16)00051-7

The Lancet Infectious Diseases

Volume 16, Issue 3, March 2016, Pages e11-e12

https://doi.org/10.1016/S1473-3099(16)00051-7 Get rights and content

Reference (1)

Joint Meeting of the Antimicrobial Drugs Advisory Committee Meeting (AMDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)

Cited by (8)

Efficacy and safety of delafloxacin, ceftaroline, ceftobiprole, and tigecycline for the empiric treatment of acute bacterial skin and skin structure infections: A network meta-analysis of randomized controlled trials
2022, Saudi Pharmaceutical Journal
Citation Excerpt :
Furthermore, the most common adverse events (AEs) reported for delafloxacin were gastrointestinally related which intensified with higher doses coupled with mild central nervous system (CNS) events (O'Riordan et al., 2018; O'Riordan et al., 2015; Pullman et al., 2017). Nevertheless, delafloxacin should still be used with caution due to the FDA warnings including the increased risk of tendonitis, peripheral neuropathy and CNS disturbances, although these adverse events have not been reported in clinical trials involving delafloxacin (Tillotson, 2016). Tigecycline has been associated with GI problems (nausea, vomiting), risk of acute pancreatitis, and has limited activity against Pseudomonas aeruginosa (Gales & Jones, 2000; Hung, Kogelman, Volpe, Iafrati, & Davidson, 2009).
This review aimed to conduct an indirect comparison using a Bayesian network meta-analysis of randomized controlled trials (RCTs) to compare the efficacy and safety of delafloxacin versus other single antibiotic regimens for the empiric treatment of Acute Bacterial Skin and Skin Structure Infections.
A systematic search with no start date restrictions was conducted. The Cochrane Risk of Bias tool was used to assess the quality of included RCTs.
Of the 577 studies initially identified, nine RCTs were included in the review. The network meta-analysis showed that ceftaroline, ceftobiprole, delafloxacin and tigecycline had similar efficacy in the indirect comparisons [Ceftaroline Odds Ratio (OR) = 1.2, 95% Crl = 0.46–3.6), ceftobiprole (OR = 1.3, 95% Crl = 0.34–3.0) and tigecycline (OR = 0.96, 95% Crl = 0.30–2.9)]. However, the ranking plot for the intention to treat (ITT) population showed that delafloxacin had a probability of 80.8% to be ranked first followed by ceftobiprole (13.1%). The analysis of the overall adverse events showed that ceftaroline (OR = 0.88, 95% Crl = 0.65–1.2), ceftobiprole (OR = 1.1, 95% Crl = 0.69–2.0), delafloxacin (OR = 0.88, 95% Crl = 0.57–1.3) and tigecycline (OR = 1.4, 95% Crl = 0.88–2.2) had similar safety profiles.
Delafloxacin did not show any statistically significant differences when compared to ceftaroline, ceftobiprole, and tigecycline in terms of efficacy and safety. However, the surface under the cumulative ranking curve (SUCRA) probability ranked delafloxacin as the first option for the ITT population.
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Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary-Care Prescribing in France, Germany and the UK: Descriptive Population-Based Study
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CommentFDA and the safe and appropriate antibiotic use of fluoroquinolones

Joint Meeting of the Antimicrobial Drugs Advisory Committee Meeting (AMDAC) and the Drug Safety and Risk Management Advisory Committee (DSaRM)

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FDA and the safe and appropriate antibiotic use of fluoroquinolones