Evidence map›Paper›PMID 40162866›Full record

ArticleBJPsych open2025

Clozapine-induced gastrointestinal hypomotility: UK pharmacovigilance reports, 2018-2022.

Robert James Flanagan, Simon Alfred Handley, Charlotte James, Lilly Wells, Susanna Every-Palmer

Abstract read
In one paragraph

Article in BJPsych open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–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

5 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Robert James FlanaganPrecision Medicine, Networked Services, King's College Hospital, London, UK.ORCID https://orcid.org/0000-0003-1081-7463
Simon Alfred HandleyBiochemistry, Department of Pathology, Royal Hobart Hospital, Hobart, Australia.
Charlotte JamesSafety and Surveillance, Medicines and Healthcare products Regulatory Agency, London, UK.
Lilly WellsSafety and Surveillance, Medicines and Healthcare products Regulatory Agency, London, UK.
Susanna Every-PalmerDepartment of Psychological Medicine, University of Otago, Wellington, New Zealand.ORCID https://orcid.org/0000-0001-6455-9741

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClozapine-induced gastrointestinal hypomotility (CIGH) can cause constipation, which may progress to ileus, intestinal perforation and other life-threatening conditions. There were at least 527 unique cases of harmful CIGH (172 deaths) assessed by strict criteria in the UK, 1992-2017.

aimsTo assess the impact of strengthened warnings about the risks of CIGH, such as those issued by the UK Medicines and Healthcare products Regulatory Agency (MHRA) (2017) and the US Food and Drug Administration (2020), on reports of harmful CIGH in the UK.

methodWe audited UK MHRA Yellow Card reports recorded as clozapine-related gastrointestinal disorders, 2018-end 2022.

resultsOf 335 unique reports (36 fatal, 26 male) that met initial CIGH criteria, there were 129 (22 fatal, 18 male) that met the final CIGH inclusion criteria. Reports of non-fatal CIGH (final criteria) averaged 26 per year (15 in 2022). Deaths averaged four per year (two in 2022). Where data were available the greatest proportion of deaths occurred after 10-14 years of clozapine treatment.

conclusionsPublicity aimed at raising awareness of the problem posed by CIGH has been associated with a reduction in harmful CIGH as reported to the UK MHRA since 2017. Continued vigilance is needed to reduce risk. Stopping smoking may pose a particular risk and should be monitored carefully.

Indexed as

Clozapineconstipationdeathgastrointestinal hypomotilitypharmacovigilance

Identifiers

PMID40162866
PMCPMC12052584

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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.