Evidence map›Paper›PMID 39209740›Full record

ArticleBMJ open ophthalmology2024

Prostaglandin analogues signal detection by data mining in the FDA Adverse Event Reporting System database.

Homero Contreras-Salinas, María Soledad Romero-López, Oscar Olvera-Montaño, Lourdes Yolotzin Rodríguez-Herrera

Abstract read
In one paragraph

Article in BMJ open ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
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

4 authors.

Homero Contreras-SalinasPharmacovigilance Department, Laboratorios Sophia SA de CV, Zapopan, Jalisco, Mexico homero.contreras@sophia.com.mx.ORCID 0000-0001-9918-2024
María Soledad Romero-LópezPharmacovigilance Department, Laboratorios Sophia SA de CV, Zapopan, Jalisco, Mexico.
Oscar Olvera-MontañoClinical Research, Laboratorios Sophia SA de CV, Zapopan, Jalisco, Mexico.
Lourdes Yolotzin Rodríguez-HerreraPharmacovigilance Department, Laboratorios Sophia SA de CV, Zapopan, Jalisco, Mexico.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study aims to identify safety signals of ophthalmic prostaglandin analogues through data mining the Food and Drug Administration Adverse Event Reporting System (FAERS) database.

methodsA data mining search by proportional reporting ratio, reporting OR, Bayesian confidence propagation neural network, information component 0.25 and χ

results12 preferred terms were statistically associated: diabetes mellitus, n=2; hypoacusis, n=2; malignant mediastinal neoplasm, n=1; blood immunoglobulin E increased, n=1; cataract, n=1; blepharospasm, n=1; full blood count abnormal, n=1; skin exfoliation, n=1; chest discomfort, n=1; and dry mouth, n=1. LIMITATION OF THE STUDY: The FAERS database's limitations, such as the undetermined causality of cases, under-reporting and the lack of restriction to only health professionals reporting this type of event, could modify the statistical outcomes. These limitations are particularly relevant in the context of ophthalmic drug analysis, as they can affect the accuracy and reliability of the data, potentially leading to biased or incomplete results.

conclusionsOur findings have revealed a potential relationship due to the biological plausibility among malignant mediastinal neoplasm, full blood count abnormal, blood immunoglobulin E increased, diabetes mellitus, blepharospasm, cataracts, chest discomfort and dry mouth; therefore, it is relevant to continue investigating the possible drug-event association, whether to refute the safety signal or identify a new risk.

Indexed as

Adverse Drug Reaction Reporting SystemsDatabases, FactualData MiningUnited States Food and Drug AdministrationAntihypertensive AgentsHumansOphthalmic SolutionsProstaglandins, SyntheticUnited StatesAntihypertensive AgentsOphthalmic SolutionsProstaglandins, SyntheticDrugsEpidemiologyGlaucomaMedical EducationPharmacology

Identifiers

PMID39209740
PMCPMC11367404

What OpenQuestion holds

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Registered trials

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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.