Evidence map›Paper›PMID 30084285›Full record

ArticleUpsala journal of medical sciences2018

Desloratadine and depression, a drug safety signal based on worldwide spontaneous reporting of side effects.

Jeltje Boer, Ellen Ederveen, Birgitta Grundmark

Open access · diamondAbstract read
In one paragraph

Article in Upsala journal of medical sciences, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 31% 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

5 citing papers in PubMed, 9 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

3 authors at 2 institutions in 2 countries.

Jeltje Boera Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch , the Netherlands.
Ellen Ederveena Netherlands Pharmacovigilance Centre Lareb, 's-Hertogenbosch , the Netherlands.
Birgitta Grundmarkb Uppsala Monitoring Centre , Uppsala , Sweden.ORCID http://orcid.org/0000-0002-2799-9374
Netherlands Pharmacovigilance Centre Lareb · NLUppsala Monitoring Centre · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveDesloratadine, a third-generation antihistamine, is claimed to cause fewer central nervous system (CNS) adverse drug reactions (ADRs) than antihistamines of the first- and second-generation. While literature is inconclusive regarding the possible CNS effects, symptoms like somnolence and hallucinations are acknowledged ADRs of desloratadine, indeed suggesting some passage of this drug across the blood-brain barrier. Depression is currently not described as an ADR in the approved desloratadine product labelling. MATERIALS AND

methodsIn a joint signal detection workshop with the Uppsala Monitoring Centre and the Netherlands Pharmacovigilance Centre Lareb, case reports of suspected drug-ADR associations were analysed.

resultsForty-nine unique case reports of desloratadine associated with depression or depressed mood were detected in the WHO global ADR database. In these reports, the median time to onset of depression was three days. Most patients recovered after withdrawal of desloratadine, and in five patients the symptoms of depression recurred after re-administration of desloratadine.

conclusionWe hypothesize that desloratadine may enter the CNS and that it hence in rare cases may cause a clinically relevant state of depression, a relation that patients and their treating physicians should be made aware of.

Indexed as

Adverse Drug Reaction Reporting SystemsDrug-Related Side Effects and Adverse ReactionsAdolescentAdultAgedBlood-Brain BarrierDepressionFemaleHumansLoratadineMaleMiddle AgedNetherlandsPatient SafetyPharmacovigilanceSwedendesloratadineLoratadineADRadverse drug reactionantihistaminedepressed mooddepressiondesloratadinepharmacovigilancesafety signalspontaneous reporting

Identifiers

PMID30084285
PMCPMC6198223
OpenAlexW2885474604

What OpenQuestion holds

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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.