Population-Level Incidence and Monitoring of Adverse Drug Reactions with Long-term Amiodarone Therapy

S. Rankin, D. H. Elder, S. Ogston, J. George, C. C. Lang, A. M. Choy (Lead / Corresponding author)

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Introduction: Amiodarone is associated with significant long-lasting adverse drug reactions (ADRs). Guidelines recommend laboratory monitoring during long-term use. However, data of compliance with laboratory monitoring is lacking.Aims: The aim of this study was to assess laboratory monitoring of liver and thyroid function during amiodarone prescribing from 1989-2011 in the Tayside, UK, population (approximately 400,000) in relation to National guidelines recommending laboratory monitoring every 6 months. We also report the population-level incidence of abnormal liver and thyroid function in relation to total exposure of amiodarone.
Methods: Utilising well-established record linkage database, a longitudinalretrospective analysis of 1413 patients on long-term amiodarone was carried out, analysing prescribing, biochemical and clinical data.
Results: Forty-six per cent (46%), 28% and 21% of patients underwent liver, thyroid, and combined testing respectively in accordance with guideline recommendations. Thirteen per cent and 17% of patients did not have any ALT or TSH testing, respectively. During follow-up, 117 (9.5%) patients had an ALT 3xULN and 16% patients had an abnormal TSH, (n=125, <0.4mU/l and n=28, >10mU/l). One-hundredand forty patients (10%) required thyroxine replacement therapy and 40 (3%) required on hyperthyroid medication. Total amiodarone exposure increased the likelihood of abnormal biochemical testing 2.5-fold after 4 years therapy for liver and thyroid function (p<0.0005)
Conclusion: In this population-based study, adherence to laboratory monitoringguidelines was sub-optimal. There was a positive correlation with total amiodarone exposure and biochemical abnormalities and development of thyroid disease compared to the general population, highlighting the need for improvement and continued amiodarone monitoring.
Original languageEnglish
Article numbere12258
Pages (from-to)1-7
Number of pages7
JournalCardiovascular Therapeutics
Issue number3
Early online date9 Mar 2017
Publication statusPublished - Jun 2017


  • Amiodarone
  • Prescribing
  • Monitoring
  • Hepatotoxicity
  • Thyroid disease
  • Adverse drug reactions


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