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The elimination half-life and drug clearance of drugs following nonlinear kinetics can vary with dosage. The Michaelis-Menten parameters and drug concentration influence these factors. As the dose increases, the elimination half-life tends to lengthen, resulting in a reduction in clearance and a disproportionately larger area under the curve. The total clearance can be derived from the Michaelis-Menten equation for drugs following a one-compartment model.
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Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
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Changes in polymorphic forms can significantly influence the bioavailability of poorly soluble drugs. Although the FDA defines pharmaceutical equivalence based on having the same active ingredient, dosage form, and route of administration, it does not automatically disqualify products with different polymorphic forms. This means two products with different polymorphs can still be deemed pharmaceutically equivalent. However, polymorphic differences can affect properties like wettability,...
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Fluoroquinolone-Associated Psychiatric and Ocular Adverse Events: A Disproportionality Analysis Using Real-World Data

Hau-Tak Chau1, Ngan Pan Bennett Au2

  • 1Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Hong Kong, Hong Kong SAR.

Pharmacology Research & Perspectives
|December 18, 2025
PubMed
Summary

Fluoroquinolone antibiotics can cause serious psychiatric and eye problems. This study found moxifloxacin has unique ocular risks, and middle-aged males are a high-risk group for suicide with fluoroquinolone use.

Keywords:
FDA adverse event reporting system (FAERS)antibioticseye disordersfluoroquinolonepharmacovigilancepsychiatric disorders

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Area of Science:

  • Pharmacovigilance and Drug Safety
  • Ophthalmology
  • Psychiatry

Background:

  • Fluoroquinolones (FQs) are widely used antibiotics with emerging concerns about severe adverse effects.
  • Real-world data analysis is crucial for understanding the full spectrum of FQ-associated risks.

Purpose of the Study:

  • To analyze psychiatric and eye-related adverse events (AEs) associated with Fluoroquinolones (FQs) using real-world data.
  • To identify specific FQs and patient demographics at higher risk for these AEs.

Main Methods:

  • Disproportionality analysis using reporting odds ratios (RORs) on FDA Adverse Event Reporting System (FAERS) data from 2011-2024.
  • Systematic characterization of psychiatric and ocular adverse events linked to six FDA-approved FQs.

Main Results:

  • Over 44,000 FQ-associated AE reports included 8,518 psychiatric and 4,367 eye-related AEs.
  • Moxifloxacin showed unique ocular toxicity signals, including iris transillumination defect and pigment dispersion syndrome.
  • Middle-aged males were identified as a high-risk demographic for suicide, despite females reporting more psychiatric AEs.

Conclusions:

  • Enhanced pharmacovigilance is needed for FQ ocular toxicity, especially with moxifloxacin, and for suicide risk in specific subgroups.
  • Robust safety monitoring is essential for early detection of neuropsychiatric and ocular complications when FQ use is necessary.