Evidence map›Paper›PMID 33338057›Full record

ArticlePloS one2020

Adverse drug reactions associated with the use of biological agents.

Jorge Enrique Machado-Alba, Anyi Liliana Jiménez-Morales, Yulieth Carolina Moran-Yela, Ilsa Yadira Parrado-Fajardo, Luis Fernando Valladales-Restrepo

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.9field-weighted citation impact, top 32% of its field
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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. 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

5 authors at 1 institution in 1 country.

Jorge Enrique Machado-AlbaGrupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.ORCID 0000-0002-8455-0936
Anyi Liliana Jiménez-MoralesUniversidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.
Yulieth Carolina Moran-YelaUniversidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.
Ilsa Yadira Parrado-FajardoGrupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Bogota DC, Colombia.
Luis Fernando Valladales-RestrepoGrupo de Investigación en Farmacoepidemiología y Farmacovigilancia, Universidad Tecnológica de Pereira-Audifarma S.A, Pereira, Risaralda, Colombia.
Technological University of Pereira · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionBiological drugs open new possibilities to treat diseases for which drug therapy is limited, but they may be associated with adverse drug reactions (ADRs).

objectiveTo identify the ADRs associated with the use of biological drugs in Colombia.

methodsThis was a retrospective study of ADR reports from 2014 to 2019, contained in the database of Audifarma SA pharmacovigilance program. The ADRs, groups of associated drugs, and affected organs were classified.

resultsIn total, 5,415 reports of ADRs associated with biological drugs were identified in 78 Colombian cities. A total of 76.1% of the cases corresponded to women. The majority were classified as type A (55.0%) and B (28.9%), and 16.7% were serious cases. The respiratory tract was the most affected organ system (16.8%), followed by the skin and appendages (15.6%). Antineoplastic and immunomodulatory drugs accounted for 70.6% of the reports, and the drugs related to the greatest number of ADRs were adalimumab (12.2%) and etanercept (11.6%).

conclusionsThe reporting of ADRs has increased in recent years and these reactions are mostly classified as tyoe A or B, categorized as serious in almost one-fifth of the reported cases and associated mainly with immunomodulators and antineoplastic agents. This type of study can support decision makers in ways that benefit patient safety and interaction with health systems.

Indexed as

Adverse Drug Reaction Reporting SystemsAntineoplastic AgentsBiological ProductsColombiaDrug-Related Side Effects and Adverse ReactionsFemaleHumansImmunologic FactorsIncidenceMalePatient SafetyPharmacovigilanceRespiratory Tract DiseasesRetrospective StudiesSkin DiseasesAntineoplastic AgentsBiological ProductsImmunologic Factors

Identifiers

PMID33338057
PMCPMC7748267
OpenAlexW3111589300

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.