Evidence map›Paper›PMID 31848905›Full record

ArticleDrugs - real world outcomes2020

Severe Cutaneous Adverse Drug Reactions Associated with Allopurinol: An Analysis of Spontaneous Reporting System in Southern Italy.

Cristina Scavone, Cristina Di Mauro, Rosanna Ruggiero, Francesca Futura Bernardi, Ugo Trama, Maria Luisa Aiezza, Concetta Rafaniello, Annalisa Capuano

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
3.4field-weighted citation impact, top 8% 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

20 citing papers in PubMed, 38 citations in OpenAlex.

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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

8 authors at 3 institutions in 1 country.

Cristina ScavoneSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Cristina Di MauroSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Rosanna RuggieroSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Francesca Futura BernardiSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Ugo TramaRegional Pharmaceutical Unit, Naples, Campania Region, Italy.
Maria Luisa AiezzaComplex Operating Unit of Pharmacy, AORN A Cardarelli, Naples, Italy.
Concetta RafanielloSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy.
Annalisa CapuanoSection of Pharmacology "L. Donatelli", Department of Experimental Medicine, Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, University of Campania "Luigi Vanvitelli", Via Costantinopoli 16, 80138, Naples, Italy. annalisa.capuano@unicampania.it.
University of Campania "Luigi Vanvitelli" · ITOspedale Antonio Cardarelli · ITRegione Campania · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAllopurinol can induce severe cutaneous adverse reactions (SCARs), including Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). AIMS AND

methodsWe analyzed the Individual Case Safety Reports (ICSRs) sent from January 2001 until April 2019 to the Campania regional Center of Pharmacovigilance (Southern Italy) that reported allopurinol as suspected, with a focus on those reporting at least one serious cutaneous adverse drug reaction (ADR). This study was aimed to describe the main characteristics of all ADRs associated with allopurinol, analyze the proportion of serious cutaneous ADRs of total ICSRs related to allopurinol and to compare the main features (age, sex, seriousness and outcome) of ICSRs that reported serious cutaneous ADRs with those that did not.

resultsThe Campania regional Center of Pharmacovigilance received 108 ICSRs that reported allopurinol as suspected. ADRs occurred more frequently in the elderly (median age: 71 years) and female patients (53.7%). Fifty-seven percent of all ADRs were classified as serious and 58% had a favorable outcome. Fifty-six ICSRs reported at least one serious cutaneous ADR; among these ICSRs, 37 cases of SCARs were found [DRESS syndrome (n = 3; 5.4%), SJS (n = 8; 14.3%) and TEN (n = 26; 46.4%)]. Serious cutaneous ADRs commonly occurred in the elderly (median age: 73 years) and female patients (62.5%). They frequently required hospitalization (75%) and had an unfavorable outcome (46%). No statistically significant differences were found between ICSRs that reported serious cutaneous ADRs and ICSRs that did not report serious cutaneous ADRs except for the seriousness degree "Hospitalization or its prolongation" and the outcome degrees "Unfavorable" and "Favorable".

conclusionThis study found that 52% (56/108) of all ICSRs having allopurinol as a suspected drug were serious cutaneous ADRs. Serious cutaneous ADRs associated with allopurinol frequently required hospitalization or prolonged hospitalization, and almost half had an unfavorable outcome.

Identifiers

PMID31848905
PMCPMC7060978
OpenAlexW2995549158

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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.