Evidence map›Paper›PMID 35661117›Full record

ArticleDrugs - real world outcomes2022

Adverse Drug Reactions of Intranasal Corticosteroids in the Netherlands: An Analysis from the Netherlands Pharmacovigilance Center.

Corine Rollema, Eric N van Roon, Corine Ekhart, Florence P A M van Hunsel, Tjalling W de Vries

Open access · goldAbstract read
In one paragraph

Article in Drugs - real world outcomes, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
3.3field-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

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Clinical Efficacy of TM02Current issues in molecular biology · 2026
    Article
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  3. Review
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  6. Article
  7. Intranasal corticosteroid users in The Netherlands: A drug utilization study.The journal of allergy and clinical immunology. Global · 2024
    Article
  8. Efficacy and safety of dupilumab in the treatment of CRSwNP in the real-life setting: a review of the literature.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Review
  9. Article
  10. Article
  11. Article
  12. Treating asthma in patients with enuresis: repercussions on urinary symptoms.International braz j urol : official journal of the Brazilian Society of Urology
    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 3 institutions in 1 country.

Corine RollemaDepartment of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Henri Dunantweg 2, P.O. Box 888, 8901 BR, Leeuwarden, The Netherlands. c.rollema@rug.nl.ORCID http://orcid.org/0000-0002-7701-3884
Eric N van RoonDepartment of Clinical Pharmacy and Pharmacology, Medical Centre Leeuwarden, Henri Dunantweg 2, P.O. Box 888, 8901 BR, Leeuwarden, The Netherlands.ORCID http://orcid.org/0000-0001-8629-7535
Corine EkhartNetherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands.ORCID http://orcid.org/0000-0002-2252-0467
Florence P A M van HunselNetherlands Pharmacovigilance Center Lareb, 's-Hertogenbosch, The Netherlands.ORCID http://orcid.org/0000-0001-8965-3224
Tjalling W de VriesDepartment of Paediatrics, Medical Centre Leeuwarden, Leeuwarden, The Netherlands.ORCID http://orcid.org/0000-0003-0940-1719
Medisch Centrum Leeuwarden · NLNetherlands Pharmacovigilance Centre Lareb · NLUniversity of Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntranasal corticosteroids are one of the cornerstone treatment options for allergic rhinitis and chronic sinusitis complaints. Safety information in the summary of product characteristics may not be representative for observations in daily clinical practice. The Netherlands Pharmacovigilance Center (Lareb) collects post-marketing safety information, using spontaneous reporting systems.

objectiveOur objective was to analyse reports of adverse drug reactions associated with intranasal corticosteroids reported in the Dutch spontaneous reporting database of the Netherlands Pharmacovigilance Center Lareb to obtain insight into real-world safety data.

methodsWe retrospectively examined all adverse drug reactions of intranasal corticosteroids reported to the Netherlands Pharmacovigilance Center Lareb, entered into the database from 1991 until 1 July, 2020.

resultsIn total, 2263 adverse drug reactions after intranasal corticosteroid use were reported in 1258 individuals. Headache (n = 143), epistaxis (n = 124) and anosmia (n = 57) were reported most frequently. Nasal septum perforation (reporting odds ratio 463.2; 95% confidence interval: 186.7-1149.7) had the highest reporting odds ratio, followed by nasal mucosal disorder (reporting odds ratio 104.5; 95% confidence interval 36.3-301.3) and hyposmia (reporting odds ratio 90.8; 95% confidence interval 45.1-182.7). Moreover, 101 (4.5%) reports were classified as serious by Lareb, including reports of Cushing's syndrome, adrenal cortical hypofunction and growth retardation.

conclusionsMany side effects are consistent with the safety information in the summary of product characteristics of intranasal corticosteroids. Several serious (systemic) side effects are reported and it is important to realise that intranasal corticosteroids may contribute to the development. Healthcare providers and patients should be aware of the potential (individual) adverse drug reactions of intranasal corticosteroids. This information could help in discussing treatment options.

Identifiers

PMID35661117
PMCPMC9392821
OpenAlexW4281734697

What OpenQuestion holds

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Registered trials

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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.