Hydrochlorothiazide and risk of hearing disorder: a case series

Abstract

BackgroundHydrochlorothiazide 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.MethodsData 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.ResultsFrom 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.ConclusionsThis 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.

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“…Moreover, since only 67% of the PTs are described with at least one defining relationship with SNOMED CT [12], it was important to check beforehand that the target terms for the cases were mapped to at least a minimal set of SNOMED CT concepts. The final 6 questions targeted were: (1) hearing disorder [35], (2) acute kidney injury [36], (3) progressive multifocal leukoencephalopathy [37], (4) glycemic dysregulation [38], (5) leukocytoclastic vasculitis [39], and (6) glaucoma [40]. In this way, these cases make it possible to test the main functions of the three tools.…”

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“…There is also a whole range of side effects, fortunately rarer, but described in the medical literature, ranging from the appearance of lupus [15], interstitial lung disease [16], even severe allergic states [17], pulmonary edema [18][19][20], all conditions linked to immunological changes induced by the molecule itself. The effect on the sense organs (hypoacusis) is more known and less rare (although investigated with low frequency, especially in the elderly subjects), with various reports from the organs of vigilance drug, for which there are well defined indications for the diagnosis of this adverse event (Austin Bradford-Hill criteria, Naranjo criteria), well applied in pharmacovigilance [21,22].…”