Hydrochlorothiazide and risk of hearing disorder: a case series
| Autor: | Selamawit Gebrehiwet, Mulugeta Russom, Yodit Fitsum, Natnael Belai |
|---|---|
| Rok vydání: | 2018 |
| Předmět: |
Male
Pediatrics medicine.medical_specialty Time Factors Vestibular disorders Administration Oral lcsh:Medicine 03 medical and health sciences 0302 clinical medicine Hydrochlorothiazide Ototoxicity Pharmacovigilance otorhinolaryngologic diseases medicine Humans Summary of Product Characteristics Hearing Loss 030223 otorhinolaryngology Antihypertensive Agents Aged WHO global adverse drug reaction database Dose-Response Relationship Drug business.industry lcsh:R General Medicine Middle Aged Hearing disorder medicine.disease Female 030211 gastroenterology & hepatology Male to female business Adverse drug reaction Research Article medicine.drug |
| Zdroj: | Journal of Medical Case Reports, Vol 12, Iss 1, Pp 1-4 (2018) Journal of Medical Case Reports |
| ISSN: | 1752-1947 |
| DOI: | 10.1186/s13256-018-1580-8 |
| Popis: | Background Hydrochlorothiazide is not known to cause hearing disorder. The Eritrean Pharmacovigilance Centre, however, has received cases of hearing disorder, including irreversible deafness, associated with hydrochlorothiazide. The aim of this study is, therefore, to assess the causal relationship between hydrochlorothiazide and hearing disorder. Methods Data was retrieved from the WHO global adverse drug reaction database, VigiBase™. A search on VigiBase™ was made on August 6, 2017 using “hydrochlorothiazide” as drug substance, and “ototoxicity”, “decreased hearing”, and “vestibular disorder” as reaction terms. Cases were retrieved using VigiLyze™ and exported to an Excel spreadsheet for descriptive analysis. Causality was assessed using Austin Bradford-Hill criteria and labeledness of the reaction was evaluated through a thorough literature review including the summary of product characteristics. Results From 1972 to August 2017, 94 cases of hearing disorder associated with hydrochlorothiazide were submitted from 18 countries to VigiBase™. The median age was 64 years with almost equal male to female ratio. In 53.2% of the cases, hydrochlorothiazide was reported as the only suspected drug. Of these, 26 cases encountered hearing disorder following the sole intake of hydrochlorothiazide. Reaction was marked as “serious” in 36% of the cases and median time to reaction onset was 3 days. Outcome was reported as reversible in 66.7% of the cases. Reaction resolved in 17 cases following withdrawal of hydrochlorothiazide and recurred in one case after subsequent rechallenge with the product. Consistency of cases and a dose–response relationship was also observed in this case series. Conclusions This case series assessment found a suggestive causal relationship between hydrochlorothiazide and hearing disorder. Taking the inherent limitations of this study into account, results should be interpreted with caution and further studies are required to validate the safety signal. |
| Databáze: | OpenAIRE |
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