Evidence map›Paper›PMID 42137313›Full record

ArticleFrontiers in pharmacology2026

Unmasking counterfeit semaglutide: analysis of real-world safety data from EudraVigilance.

Alessia Zinzi, Mario Gaio, Rosanna Ruggiero, Annamaria Mascolo, Maria Antonietta Riemma, Mattia Cipriani, Ludovica Vittoria Laino, Liberato Berrino, Francesco Rossi, Annalisa Capuano

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Article in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

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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

10 authors.

Alessia Zinzi *Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Mario Gaio *Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Rosanna RuggieroDepartment of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Annamaria MascoloDepartment of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Maria Antonietta RiemmaDepartment of Experimental Medicine - Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Naples, Italy.
Mattia CiprianiCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Ludovica Vittoria LainoCampania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.
Liberato BerrinoDepartment of Experimental Medicine - Section of Pharmacology "L. Donatelli", University of Campania "Luigi Vanvitelli", Naples, Italy.
Francesco Rossi *Department of Life Science, Health, and Health Professions, Link Campus University, Rome, Italy.
Annalisa Capuano *Campania Regional Centre for Pharmacovigilance and Pharmacoepidemiology, Naples, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The spread of counterfeit drugs represents a serious threat to public health because they may be ineffective or cause the onset of severe suspected adverse drug reactions (ADRs). To date, the traceability of semaglutide-based products, widely used off-label for weight loss, is not a well-studied area. Methods: The aim of this study was to perform a descriptive analysis to explore and describe the characteristics of safety cases related to potential counterfeit semaglutide products by using the European pharmacovigilance database EudraVigilance. Individual Case Safety Reports (ICSRs) were retrieved over the period from 1 January 2018 to 31 December 2025. Results: A total of 234 Individual Case Safety Reports (ICSRs) related to potential counterfeit semaglutide were retrieved from EudraVigilance, of which N = 172 (73.5%) were related to females and N = 83 (35.5%) to adult patients. A total of 89.3% of all suspected ADRs were serious. The most frequently reported suspected ADRs were "vomiting", "nausea", and "hypoglycemia". The analysis of disproportionality showed a higher reporting frequency of "hypoglycemia", "product use in unapproved indication", "malaise", and "drug ineffective" with potential counterfeit semaglutide compared to non-counterfeit semaglutide. Discussion: The present pharmacovigilance study showed a useful role in identifying potential counterfeit medicine suspected ADRs. Further studies are warranted.

Indexed as

counterfeitingcounterfeit semaglutideeudravigilanceGLP-1obesitypharmacovigilancesafety

Identifiers

PMID42137313
PMCPMC13168152

What Socratic holds

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