Evidence map›Paper›PMID 20213329›Full record

ArticleInflammopharmacology2010

FDA proposals to limit the hepatotoxicity of paracetamol (acetaminophen): are they reasonable?

Garry G Graham, Richard O Day, Andis Graudins, Anthoulla Mohamudally

Erratum issuedAbstract read
PubMed Publisher
In one paragraph

Article in Inflammopharmacology, 2010. 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 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  12. Piroxicam-β-cyclodextrin: a GI safer piroxicam.Current medicinal chemistry · 2013
    Review
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

4 authors.

Garry G GrahamDepartment of Clinical Pharmacology, St Vincent's Hospital, Darlinghurst, NSW, 2010, Australia. g.graham@unsw.edu.au
Richard O Day
Andis Graudins
Anthoulla Mohamudally

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hepatotoxicity from paracetamol is of great concern because of the considerable number of patients who develop severe toxicity from this drug. A group of senior medical practitioners, academics and scientists were brought together on June 29 and 30, 2009 by the Food and Drug Administration of USA (FDA) with the aim of providing advice on how to limit the number of cases of hepatotoxicity due to paracetamol in USA. The most contentious recommendations were the reduction in the dose of paracetamol to 650 mg and the elimination of prescription combination products of paracetamol and opiates. The first recommendation indicates that many members of the committee consider, despite much evidence to the contrary, that therapeutic doses of paracetamol (up to 4 g daily) are associated with a significant incidence of hepatotoxicity. The second recommendation, if accepted by FDA, will require major changes in the therapeutic use of paracetamol and opiates. Adoption of these two recommendations may lead to the increased use of NSAIDs with the potential of increasing incidence of NSAIDs-related adverse reactions.

Indexed as

Advisory CommitteesUnited States Food and Drug AdministrationAcetaminophenAlcohol DrinkingAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalChemical and Drug Induced Liver InjuryDrug and Narcotic ControlDrug CombinationsDrug LabelingDrug PackagingDrug-Related Side Effects and Adverse ReactionsHumansNonprescription DrugsPainPrescription DrugsAcetaminophenAnalgesics, OpioidAnti-Inflammatory Agents, Non-SteroidalDrug CombinationsNonprescription DrugsPrescription Drugs

Identifiers

PMID20213329

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.