Evidence map›Paper›PMID 41139841›Full record

ArticleMultiple sclerosis (Houndmills, Basingstoke, England)2025

Anaphylaxis and glatiramer acetate.

Tiffany B Kim, Jenni Yoon Lee, Allen Brinker, Paul R Lee, Laura E Baldassari, Daniela A Pimentel Maldonado, Alice Hughes, Vicky Chan

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Multiple sclerosis (Houndmills, Basingstoke, England), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Tiffany B KimDivision of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.ORCID 0009-0008-1556-9861
Jenni Yoon LeeDivision of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.
Allen BrinkerDivision of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.
Paul R LeeDivision of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.ORCID 0000-0002-6681-562X
Laura E BaldassariDivision of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-1795-1542
Daniela A Pimentel MaldonadoDivision of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.
Alice HughesDivision of Neurology 2, Office of Neuroscience, Office of New Drugs, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.
Vicky ChanDivision of Pharmacovigilance I, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food & Drug Administration, Silver Spring, MD, USA.ORCID 0000-0003-2791-9001

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

backgroundImmediate post-injection reactions were commonly observed in registrational trials of glatiramer acetate (GA) for the treatment of multiple sclerosis. Immediate post-injection reactions, characterized by a constellation of symptoms that may occur immediately after injection, can involve signs and symptoms that resemble those of anaphylaxis.

objectiveThe objective of this study is to describe cases of serious anaphylaxis that supported the postmarketing safety labeling change for GA in the United States.

methodsA review of the Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) database and published medical literature was conducted.

resultsWe identified 82 cases of anaphylaxis with GA in FAERS and the medical literature. Six cases reported a fatal outcome (3 anaphylaxis, 3 sudden death). These cases reported anaphylaxis occurring in patients 1 week to 72 months following initiation of GA, including 19 cases that reported anaphylaxis more than 1 year following initiation of GA.

conclusionAs these reactions have implications for prescribing decisions and patient management, the FDA issued a labeling change notification to update the WARNINGS AND PRECAUTIONS section and add a BOXED WARNING to the United States prescribing information for GA. A Drug Safety Communication was also issued to inform the public about this update.

Indexed as

AnaphylaxisGlatiramer AcetateImmunosuppressive AgentsMultiple SclerosisPeptidesAdultAdverse Drug Reaction Reporting SystemsDrug LabelingFemaleHumansMaleMiddle AgedProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationGlatiramer AcetateImmunosuppressive AgentsPeptidesanaphylaxisGlatiramer acetatemultiple sclerosis

Identifiers

PMID41139841
PMCPMC12969645

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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.