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Background/aim <p>In 2018, the European Medicines Agency strengthened warnings in relation to fluoroquinolone (FQ)-associated tendon injury. There is a lack of published data on FQs and tendon injury in an Irish context. The aim of the study was to investigate incidents and claims relating to FQs and tendon injury through an analysis of National Incident Management System (NIMS) data.</p> Methods <p>The NIMS database was searched for incidents created between 1st June 2018 and 31st May 2023 which involved any FQ and referenced tendon injury. The incident data was analysed under predetermined field headings. NIMS was also searched for clinical claims involving any FQ with a Claim Finalised Date between 1st June 2018 and 31st May 2023. The claims were analysed to identify common themes.</p> Results <p>The study identified 20 incidents which related to FQs and tendon injury, although only six reported an actual tendon injury. In 15 (75%) of the incidents, the prescription of a FQ was deemed inappropriate by the reporter. The study found four finalised claims, all of which related to bilateral Achilles tendon rupture following FQ exposure. In all four cases, the patient was aged over 60 and the injury occurred within days of commencing treatment.</p> Conclusions <p>This study confirms that FQs continue to be prescribed inappropriately in high-risk patients and that incidents of tendon injury following FQ exposure continue to occur despite regulatory moves of raise awareness of this issue. Additional measures to minimise the risk of avoidable patient harm may be warranted.</p>

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Fluoroquinolones and tendon injury: a 5-year review of Irish national incident and claims data

  • 期刊论文

  • 发表日期：

    2025年2月27日

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  • Mark McCullagh,
  • Natasha Coen,
  • Cathal O’Keeffe

摘要

Background/aim

In 2018, the European Medicines Agency strengthened warnings in relation to fluoroquinolone (FQ)-associated tendon injury. There is a lack of published data on FQs and tendon injury in an Irish context. The aim of the study was to investigate incidents and claims relating to FQs and tendon injury through an analysis of National Incident Management System (NIMS) data.

Methods

The NIMS database was searched for incidents created between 1st June 2018 and 31st May 2023 which involved any FQ and referenced tendon injury. The incident data was analysed under predetermined field headings. NIMS was also searched for clinical claims involving any FQ with a Claim Finalised Date between 1st June 2018 and 31st May 2023. The claims were analysed to identify common themes.

Results

The study identified 20 incidents which related to FQs and tendon injury, although only six reported an actual tendon injury. In 15 (75%) of the incidents, the prescription of a FQ was deemed inappropriate by the reporter. The study found four finalised claims, all of which related to bilateral Achilles tendon rupture following FQ exposure. In all four cases, the patient was aged over 60 and the injury occurred within days of commencing treatment.

Conclusions

This study confirms that FQs continue to be prescribed inappropriately in high-risk patients and that incidents of tendon injury following FQ exposure continue to occur despite regulatory moves of raise awareness of this issue. Additional measures to minimise the risk of avoidable patient harm may be warranted.