Evidence map›Paper›PMID 34211690›Full record

ArticleTherapeutic advances in drug safety2021

Tramadol-induced hiccups: a case-noncase study in the European pharmacovigilance database.

Montserrat García, Unax Lertxundi, Carmelo Aguirre

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Article in Therapeutic advances in drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

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4citing papers in PubMed
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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Montserrat GarcíaOsakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Biocruces Bizkaia Health Research Institute, Barrio Labeaga 46A, Galdakao, 48960, Spain.ORCID https://orcid.org/0000-0001-7026-1079
Unax LertxundiAraba Mental Health Network, Araba Psychiatric Hospital, Pharmacy Service, Bioaraba Health Research Institute, Osakidetza Basque Health Service, Vitoria-Gasteiz, Araba, Spain.
Carmelo AguirreOsakidetza Basque Health Service, Galdakao-Usansolo Hospital, Basque Country Pharmacovigilance Unit, Biocruces Bizkaia Health Research Institute, Galdakao, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHiccups are usually benign and self-limiting, but can sometimes be persistent. If left untreated, they can provoke severe discomfort, and even death. Hiccups can be idiopathic, organic, psychogenic, and caused by drugs. Although some case reports have suggested a possible association between tramadol and hiccups, to our knowledge, no study has analyzed this possible relationship. The aim of this study was to analyze whether a disproportionate number of cases of hiccups are reported for tramadol in the EudraVigilance database.

methodsA case-noncase study was conducted to assess the association between hiccups and tramadol, calculating reporting odds ratios (RORs) from 1 January 1995 to 11 September 2020. Cases were selected using the preferred term 'Hiccups'. The noncases used as controls were all other adverse drug reaction reports recorded in EudraVigilance during the same period. Exposure was defined as exposure to tramadol among cases and noncases. To reduce the risk of confounding by indication, the RORs for tramadol compared with other opioids were obtained. Additionally, we performed a confirmatory analysis in the World Health Organization pharmacovigilance database, VigiBase

resultsThere were 3089 cases of hiccups in the 7,213,623 reports. Tramadol was involved in 50 cases. The ROR for tramadol exposure was 3.35 [95% confidence interval (CI) 2.53-4.43]. This association persisted when comparing tramadol with other opioids; ROR: 2.13 (95% CI 1.52-2.99). Disproportionality was also observed in VigiBase

conclusionOur study confirms, for the first time, a possible signal for a tramadol-hiccups association. Nevertheless, observational analytical studies are needed to confirm these results. PLAIN LANGUAGE SUMMARY: Evaluation of the relationship between the tramadol and the risk of hiccups

Indexed as

drug safety surveillanceEudraVigilancehiccupsspontaneous reporting systemtramadol

Identifiers

PMID34211690
PMCPMC8216342

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