Neubert Ann, Tannert Sabine, Pirk Gwenda
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit.
Tierarztl Prax Ausg K Kleintiere Heimtiere. 2022 Aug;50(4):269-278. doi: 10.1055/a-1907-4387. Epub 2022 Sep 6.
Hearing loss occurring in temporal association with the topical application of otic medications is regularly reported to the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL) in the form of adverse event (AE) reports. Although deafness or impaired hearing are listed as possible adverse reactions in the Summary of Product Characteristics of the otic medications approved in Germany little information about the underlying causes is available to date.
A search for cases reporting impaired hearing following the use of otic medication was conducted in the national AE database. Subsequently, descriptive analysis was performed. Due to their small number, cases involving cats were excluded. Possible risk factors and causes of hearing loss were considered against the background of current literature.
While dogs of all age groups were affected, the majority of reports referred to dogs older than 10 years of age. Besides crossbreds, dogs of the breeds West Highland White Terrier, Dalmatian, Miniature Poodle and French Bulldog were most frequently involved. The analysis of the available data does not point to specific products or active substances that could be associated with a more frequent occurrence of hearing loss.
In addition to possible ototoxicity of a product, other causes of hearing loss should be considered. These include the underlying otitis itself, age-related hearing loss, previously undetected unilateral congenital deafness, or conductive deafness due to obstruction of the ear canal. Treatment options include discontinuation of potentially ototoxic substances or treatment of conductive deafness, e. g. by removal of drug residues and exudate or treatment of otitis media. In the case of hearing loss subsequent to the use of otic medication, the BVL should be notified of this event in as much detail as possible in order to further improve the data situation concerning this topic.
与耳用药物局部应用在时间上相关联发生的听力损失，经常以不良事件（AE）报告的形式上报给联邦消费者保护和食品安全局（Bundesamt für Verbraucherschutz und Lebensmittelsicherheit - BVL）。尽管在德国批准的耳用药物的产品特性摘要中，耳聋或听力受损被列为可能的不良反应，但迄今为止，关于潜在原因的信息很少。
在国家AE数据库中搜索使用耳用药物后报告听力受损的病例。随后进行描述性分析。由于涉及猫的病例数量较少，故将其排除。根据当前文献背景考虑听力损失的可能风险因素和原因。
所有年龄组的犬均受影响，但大多数报告涉及10岁以上的犬。除杂交犬外，西高地白梗、大麦町犬、迷你贵宾犬和法国斗牛犬品种的犬最常涉及。对现有数据的分析未指向可能与听力损失更频繁发生相关的特定产品或活性物质。
除产品可能的耳毒性外，还应考虑听力损失的其他原因。这些原因包括潜在的中耳炎本身、与年龄相关的听力损失、先前未检测到的单侧先天性耳聋或由于耳道阻塞引起的传导性耳聋。治疗选择包括停用潜在的耳毒性物质或治疗传导性耳聋，例如通过清除药物残留和渗出物或治疗中耳炎。在使用耳用药物后发生听力损失的情况下，应尽可能详细地将此事件通知BVL，以进一步改善有关该主题的数据情况。
