Evidence map›Paper›PMID 38667570›Full record

ArticleHealthcare (Basel, Switzerland)2024

Exploring Adverse Drug Reactions in Psychotropic Medications: A Retrospective Analysis of Portuguese Pharmacovigilance Data.

Ana Bandarra, César Costa, Kristina Angelova, Lília Leonardo, Margarida Espírito-Santo

Open access · goldAbstract read
In one paragraph

Article in Healthcare (Basel, Switzerland), 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, top 95% 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

1 citing paper in PubMed, 0 citations in OpenAlex.

  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

5 authors at 2 institutions in 1 country.

Ana BandarraFaculty of Sciences and Technology, University of Algarve, 8005-139 Faro, Portugal.
César CostaUnidade de Farmacovigilância do Algarve e Baixo Alentejo (UFALBA), University of Algarve, Campus de Gambelas, Building 2, Office no. 2.52, 8005-139 Faro, Portugal.
Kristina AngelovaUnidade de Farmacovigilância do Algarve e Baixo Alentejo (UFALBA), University of Algarve, Campus de Gambelas, Building 2, Office no. 2.52, 8005-139 Faro, Portugal.
Lília LeonardoUnidade de Farmacovigilância do Algarve e Baixo Alentejo (UFALBA), University of Algarve, Campus de Gambelas, Building 2, Office no. 2.52, 8005-139 Faro, Portugal.
Margarida Espírito-SantoUnidade de Farmacovigilância do Algarve e Baixo Alentejo (UFALBA), University of Algarve, Campus de Gambelas, Building 2, Office no. 2.52, 8005-139 Faro, Portugal.ORCID 0000-0002-2200-0015
University of Algarve · PTAlgarve Biomedical Center · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Psychotropic drugs (PDs) include anxiolytics, sedatives and hypnotics, antidepressants, and antipsychotics, and they are available as medicines with different safety profiles. Given Portugal's high anxiolytic consumption and the rising prevalence of mental disorders, safety monitoring is crucial. This study aimed to analyze the individual case safety reports (ICSR) of suspected adverse drug reactions (ADRs) related to PDs, obtained through spontaneous reporting, and recorded in the Portuguese National Pharmacovigilance System between January 2017 and December 2021. This observational and retrospective study analyzed the ICSRs of suspected ADRs to PDs. Most reports pertained to female individuals (67.78%) between 18 and 64 years of age (63.71%). The pharmaceutical industry was the primary source of these reports (62.16%). Antidepressants were responsible for most ICSRs (61.90%). At least one serious ADR was recorded in 58.44% of the reports, and 43.84% of ADRs evolved into "cure". The most-observed ADRs were nausea (10.92%), dizziness (10.70%), and off-label use (10.30%). In the causality assessment, 45.49% of ADRs were classified as "possible", and only 4.96% were classified as "definitive". The current analysis helps to strengthen the safety evidence for PDs. In the future, some measures could be implemented to improve the use of and/or access to PDs, as well as to reinforce the rate of suspected ADR reports within the community, contributing to the safety data available.

Indexed as

adverse drug reactionpharmacovigilancepsychotropic drugsspontaneous report

Identifiers

PMID38667570
PMCPMC11050660
OpenAlexW4394603125

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.