Evidence map›Paper›PMID 32904545›Full record

ArticleDrug, healthcare and patient safety2020

Amoxicillin and Risk of Hearing Loss: Analysis of Reported Cases Submitted to the WHO Global Database.

Mulugeta Russom, Aziza Afendi, Amon Solomon Ghebrenegus

Abstract read
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Article in Drug, healthcare and patient safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited 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

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4 · The record

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5 · Who and what money

Authors and funding

3 authors.

Mulugeta RussomEritrean Pharmacovigilance Centre, National Medicines and Food Administration, Asmara, Eritrea.ORCID 0000-0003-1939-5842
Aziza AfendiEritrean Pharmacovigilance Centre, National Medicines and Food Administration, Asmara, Eritrea.ORCID 0000-0003-4569-9858
Amon Solomon GhebrenegusEritrean Pharmacovigilance Centre, National Medicines and Food Administration, Asmara, Eritrea.ORCID 0000-0002-1264-6285

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPenicillins have never been associated with any form of hearing disorders. The Eritrean Pharmacovigilance Centre recently received two cases of hearing disorder (including one case of deafness) following the intake of amoxicillin capsules. This study was conducted to assess the causal link between amoxicillin and deafness.

methodsData mining was carried out in the WHO global database of individual case safety reports, VigiBase, and the Austin Bradford-Hill criteria were used to assess causality.

resultsA total of 94 cases of 'hearing disorders' related to amoxicillin were retrieved from VigiBase. Of these, 49 (52.1%) were reported as "deafness," and amoxicillin was marked as the sole suspected drug in 18 and the only drug administered in 13 cases. In the rest of the deafness cases (n=31), amoxicillin was concurrently administered with other drugs and reported as co-suspected. The median time to onset was three days and the outcome was marked as recovered (14), recovering (2), not recovered (16) and unknown (17). In five cases, deafness resolved following the withdrawal of amoxicillin.

conclusionThere appears a causal association between amoxicillin and hearing loss that requires further substantiation with better epidemiologic studies.

Indexed as

amoxicillindeafnesshearing disorderVigiBase

Identifiers

PMID32904545
PMCPMC7457569

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