Evidence map›Paper›PMID 28480041›Full record

ArticlePharmacology research & perspectives2017

Risk of QT prolongation and torsade de pointes associated with exposure to hydroxyzine: re-evaluation of an established drug.

Anne-Françoise Schlit, Annie Delaunois, Aurore Colomar, Branderley Claudio, Luca Cariolato, Rossen Boev, Jean-Pierre Valentin, Christopher Peters, Victor S Sloan, Jürgen W G Bentz

Abstract read
In one paragraph

Article in Pharmacology research & perspectives, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing 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

23 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Revisiting the QT Interval: An Old Marker for a New Disease?Arquivos brasileiros de cardiologia · 2023
    Article
  11. Safety of hydroxyzine in the sedation of pediatric dental patients.Journal of dental anesthesia and pain medicine · 2022
    Review
  12. Article
  13. Oral sedation in dentistry: evaluation of professional practice of oral hydroxyzine in the University Hospital of Rennes, France.European archives of paediatric dentistry : official journal of the European Academy of Paediatric Dentistry · 2021
    Article
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Towards definitive management of allergic rhinitis: best use of new and established therapies.Allergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2020
    Review
  20. CSACI position statement: Newer generation HAllergy, asthma, and clinical immunology : official journal of the Canadian Society of Allergy and Clinical Immunology · 2019
    Review
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

10 authors.

Anne-Françoise SchlitUCB Pharma Brussels Belgium.
Annie DelaunoisUCB Pharma Brussels Belgium.
Aurore ColomarUCB Pharma Brussels Belgium.
Branderley ClaudioUBC Geneva Switzerland.
Luca CariolatoUBC Geneva Switzerland.
Rossen BoevUCB Pharma Bulle Switzerland.
Jean-Pierre ValentinUCB Pharma Brussels Belgium.
Christopher PetersUCB Pharma Brussels Belgium.
Victor S SloanUCB Pharma Raleigh North Carolina USA.
Jürgen W G BentzUCB Pharma Brussels Belgium.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Several noncardiac drugs have been linked to cardiac safety concerns, highlighting the importance of post-marketing surveillance and continued evaluation of the benefit-risk of long-established drugs. Here, we examine the risk of QT prolongation and/or torsade de pointes (TdP) associated with the use of hydroxyzine, a first generation sedating antihistamine. We have used a combined methodological approach to re-evaluate the cardiac safety profile of hydroxyzine, including: (1) a full review of the sponsor pharmacovigilance safety database to examine real-world data on the risk of QT prolongation and/or TdP associated with hydroxyzine use and (2) nonclinical electrophysiological studies to examine concentration-dependent effects of hydroxyzine on a range of human cardiac ion channels. Based on a review of pharmacovigilance data between 14th December 1955 and 1st August 2016, we identified 59 reports of QT prolongation and/or TdP potentially linked to hydroxyzine use. Aside from intentional overdose, all cases involved underlying medical conditions or concomitant medications that constituted at least 1 additional risk factor for such events. The combination of cardiovascular disorders plus concomitant treatment of drugs known to induce arrhythmia was identified as the greatest combined risk factor. Parallel patch-clamp studies demonstrated hydroxyzine concentration-dependent inhibition of several human cardiac ion channels, including the ether-a-go-go-related gene (hERG) potassium ion channels. Results from this analysis support the listing of hydroxyzine as a drug with "conditional risk of TdP" and are in line with recommendations to limit hydroxyzine use in patients with known underlying risk factors for QT prolongation and/or TdP.

Indexed as

HydroxyzineminimizationQT prolongationrisktorsade de pointes

Identifiers

PMID28480041
PMCPMC5415947

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.