Adverse reaction reporting of interaction between warfarin and fluoroquinolones

H M Jolson1, L A Tanner, L Green

  • 1Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD.

Insights

This study reviewed adverse drug reactions, finding that fluoroquinolones may prolong prothrombin time in patients taking warfarin sodium. Close monitoring of prothrombin time is recommended when these drugs are used together.

Area of Science:

  • Pharmacology
  • Drug Interactions
  • Clinical Medicine

Background:

  • Warfarin sodium is a widely used anticoagulant.
  • Fluoroquinolones are broad-spectrum antibiotics.
  • Potential drug interactions require careful consideration for patient safety.

Purpose of the Study:

  • To investigate suspected interactions between warfarin sodium and fluoroquinolones.
  • To analyze adverse event reports of prolonged prothrombin time.
  • To identify potential mechanisms for this drug interaction.

Main Methods:

  • Review of adverse event reports submitted to the Food and Drug Administration's Adverse Drug Reaction Reporting System.
  • Analysis of five case reports detailing prolonged prothrombin time.
  • Examination of potential pharmacological mechanisms.

Main Results:

  • Five reports indicated prolonged prothrombin time after initiating fluoroquinolone therapy in patients on warfarin.
  • The adverse reaction occurred within 2 to 16 days of adding the fluoroquinolone.
  • Potential mechanisms include inhibited warfarin metabolism and protein binding displacement.

Conclusions:

  • A potential interaction exists between warfarin sodium and fluoroquinolones, leading to increased prothrombin time.
  • Physicians should be vigilant for this interaction.
  • Close monitoring of prothrombin time is crucial for patients on concurrent warfarin and fluoroquinolone therapy.

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