ArticleDrug safety2018
Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence.
Article in Drug safety, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 15 papers, 1 of them a synthesis that pooled it.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.
- Global patterns of opioid use and dependence: harms to populations, interventions, and future action.Lancet (London, England) · 2019Pooled it
- Pharmacotherapy and overdose risk following new opioid use disorder diagnosis among Medicaid beneficiaries.The American journal of drug and alcohol abuse · 2026Article
- Goofballing of Opioid and Methamphetamine: The Science Behind the Deadly Cocktail.Frontiers in pharmacology · 2022Review
- Slow-sustained delivery of naloxone reduces typical naloxone-induced precipitated opioid withdrawal effects in male morphine-dependent mice.Journal of neuroscience research · 2022Article
- Optimizing the impact of medications for opioid use disorder at release from prison and jail settings: A microsimulation modeling study.The International journal on drug policy · 2021Article
- Evaluation of Opioid Overdose Reports in Patients Treated with Extended-Release Naltrexone: Postmarketing Data from 2006 to 2018.Drug safety · 2021Article
- Review
- America's opioid crisis: the need for an integrated public health approach.Translational psychiatry · 2020Review
- Reconsidering the Usefulness of Adding Naloxone to Buprenorphine.Frontiers in psychiatry · 2020Article
- Potential uses of naltrexone in emergency department patients with opioid use disorder.Clinical toxicology (Philadelphia, Pa.) · 2019Review
- Overdose following initiation of naltrexone and buprenorphine medication treatment for opioid use disorder in a United States commercially insured cohort.Drug and alcohol dependence · 2019Article
- The United States opioid epidemic.Seminars in perinatology · 2019Review
- Comment on "Review of Case Narratives from Fatal Overdoses Associated with Injectable Naltrexone for Opioid Dependence".Drug safety · 2018Article
- Potential Risk Window for Opioid Overdose Related to Treatment with Extended-Release Injectable Naltrexone.Drug safety · 2018Article
- Commentary on Ajazi et al (2021) Re-analysis of the X:BOT Trial.Journal of addiction medicineArticle
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionAn extended-release injectable naltrexone suspension (Vivitrol
methodsWe performed a retrospective case review of Vivitrol spontaneous reports (October 2010-March 2016) in the US Food and Drug Administration Adverse Event Reporting System via the Freedom of Information Act. Case narratives were manually reviewed to identify overdose deaths amongst current and former patients, extracting information on the time from discontinuation, followed by causality assessment.
resultsNarratives on 263 deaths and overdose-related outcomes were obtained. One hundred and forty-five death reports were assessed for causality. Among these reports, cause of death was unknown in 46%, while 52 fatal overdoses met the case definition. Of 52 overdoses, time between the last dose and death was known for 28; 22 (84.6%) occurred within 2 months of the last Vivitrol injection [median 46 days (interquartile range 29.5-82)]. The sponsor's causality assessment in 75% of fatal overdoses repeated verbatim text that placed responsibility on underlying opioid dependence and precluded a link between medication and overdose or ignored rebound risk following treatment discontinuation.
conclusionsVivitrol adverse event reports suggest the need to investigate two months following the last medicine injection as a period of particular concern for overdose. A registry study would best quantify risk. Providers should report suspected post-discontinuation overdoses to government authorities.
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What OpenQuestion holds
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.