ArticleAddiction (Abingdon, England)2015
Arrhythmia associated with buprenorphine and methadone reported to the Food and Drug Administration.
Article in Addiction (Abingdon, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06940570 (A Randomized Single Center Trial to Determine the Efficacy of Methadone as a First Line Agent in the Reduction and Treatment of Pain in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation), which is not on this map. Cited by 32 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Single Center Trial to Determine the Efficacy of Methadone as a First Line Agent in the Reduction and Treatment of Pain in Pediatric Patients Undergoing Hematopoietic Stem Cell Transplantation
Who cites it
32 citing papers in PubMed, 87 citations in OpenAlex.
- Safety profile of progesterone: Insights from an FDA Adverse Event Reporting System (FAERS)-based pharmacovigilance study.The Journal of international medical research · 2026Observational
- Systemic administration of analgesic buprenorphine, but not carprofen, affects cardiomyocyte contractility in rodents.Journal of molecular and cellular cardiology plus · 2025Article
- Methadone Blockade of Inward Rectifier Potassium Current Promotes Both Early and Delayed Repolarization Arrhythmias: Mechanistic Insights From Computational Modeling.Journal of the American Heart Association · 2025Article
- Use of Medications for Opioid Use Disorder in Older Adults.American journal of preventive medicine · 2025Article
- Article
- The impact of medication-assisted treatment for opioid use disorder on congestive heart failure outcomes.American heart journal plus : cardiology research and practice · 2024Article
- Sleep-Disordered Breathing Destabilizes Ventricular Repolarization.medRxiv : the preprint server for health sciences · 2024Article
- Development of prescribing indicators related to opioid-related harm in patients with chronic pain in primary care-a modified e-Delphi study.BMC medicine · 2024Review
- Electrocardiographic Abnormalities During and After Withdrawal in Patients Diagnosed with Opioid Use Disorder.Noro psikiyatri arsivi · 2023Article
- Identifying Clinically Relevant Drug-Drug Interactions With Methadone and Buprenorphine: A Translational Approach to Signal Detection.Clinical pharmacology and therapeutics · 2022Article
- Methadone Blockade of Cardiac Inward Rectifier KJournal of the American Heart Association · 2022Article
- Antipsychotic Polypharmacy-Related Cardiovascular Morbidity and Mortality: A Comprehensive Review.Neurology international · 2022Review
- Effects of opioid receptor agonist and antagonist medications on electrocardiogram changes and presentation of cardiac arrhythmia: review article.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2022Review
- Opioids for chronic pain management in patients with dialysis-dependent kidney failure.Nature reviews. Nephrology · 2022Review
- The Risk of Ventricular Dysrhythmia or Sudden Death in Patients Receiving Serotonin Reuptake Inhibitors With Methadone: A Population-Based Study.Frontiers in pharmacology · 2022Article
- A New Era in Pharmacovigilance: Toward Real-World Data and Digital Monitoring.Clinical pharmacology and therapeutics · 2021Review
- Data Resource Profile: The Opioid Agonist Treatment and Safety (OATS) Study, New South Wales, Australia.International journal of epidemiology · 2021Article
- Buprenorphine for Chronic Pain: A Safer Alternative to Traditional Opioids.Health psychology research · 2021Review
- Review
- [Aging in a methadone maintenance program. A perspective from the framework of social determinants of health].Revista espanola de salud publica · 2019Article
Corrections and comments
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Authors and funding
4 authors at 3 institutions in 1 country.
Funding
Abstract
aimTo assess the relative frequency of reporting of adverse events involving ventricular arrhythmia, cardiac arrest, corrected QT interval (QTc) prolongation or torsade de pointes to the US Food and Drug Administration (FDA) between buprenorphine and methadone.
designRetrospective pharmacoepidemiological study.
settingAdverse drug events reported spontaneously to the FDA between 1969 and June 2011 originating in 196 countries (71% events from the United States). CASES: Adverse event cases mentioning methadone (n = 14 915) or buprenorphine (n = 7283) were evaluated against all other adverse event cases (n = 4 796 017). MEASUREMENTS: The primary outcome was the composite of ventricular arrhythmia or cardiac arrest. The secondary outcome was the composite of QTc prolongation or torsade de pointes. The proportional reporting ratio (PRR) was used to identify disproportionate reporting defined as a PRR > 2, χ(2) error > 4, with ≥ 3 cases.
findingsThere were 132 (1.8%) ventricular arrhythmia/cardiac arrest and 19 (0.3%) QTc prolongation/torsade de pointes cases associated with buprenorphine compared with 1729 (11.6%) ventricular arrhythmia/cardiac arrest and 390 (2.6%) QTc prolongation/torsade de pointes cases involving methadone. PRRs associated with buprenorphine were not significant for ventricular arrhythmia/cardiac arrest (1.10, 95%, confidence interval (0.93-1.31, χ(2) = 1.2) or QTc prolongation/torsade de pointes (1.03, 95% CI = 0.66-1.62, χ(2) = 0.01), but were for methadone (7.20, 95% CI = 6.88-7.52, χ(2) = 8027; 10.7, 95% CI = 9.66-11.8, χ(2) = 1538, respectively).
conclusionIn spontaneously reported adverse events, methadone is associated with disproportionate reporting of cardiac arrhythmias, whereas buprenorphine is not. Although these findings probably reflect clinically relevant differences, a causal connection cannot be presumed and disproportionality analysis cannot quantify absolute risk per treatment episode. Population-based studies to definitively quantify differential incidence rates are warranted.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.