@article{enlighten138520, volume = {35}, number = {3}, month = {June}, author = {S. Rankin and D.H. Elder and S. Ogston and J. George and C.C. Lang and A.M. Choy}, title = {Population-level incidence and monitoring of adverse drug reactions with long-term amiodarone therapy}, publisher = {Wiley}, journal = {Cardiovascular Therapeutics}, year = {2017}, keywords = {Adverse drug reactions, amiodarone, hepatotoxicity, monitoring, prescribing, thyroid disease.}, url = {https://eprints.gla.ac.uk/138520/}, abstract = {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 are lacking. Aims: The aim of this study was to assess laboratory monitoring of liver and thyroid function during amiodarone prescribing from 1989 to 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: Utilizing well-established record-linkage database, a longitudinal retrospective analysis of 1413 patients on long-term amiodarone was carried out, analyzing prescribing, biochemical, and clinical data. Results: Forty-six percent (46\%), 28\%, and 21\% of patients underwent liver, thyroid, and combined testing, respectively, in accordance with guideline recommendations. Thirteen percent and 17\% of patients did not have any ALT or TSH testing, respectively. During follow-up, 117 (9.5\%) patients had an ALT 3{$\times$}ULN and 16\% patients had an abnormal TSH, (n=125, \<0.4�mU/L and n=28, {\ensuremath{>}}10�mU/L). One hundred and 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\<.0005). Conclusion: In this population-based study, adherence to laboratory monitoring guidelines was suboptimal. 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.}, doi = {10.1111/1755-5922.12258} }