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Ototoxic eardrops and tympanic membrane perforations: time for a change?
1Department of Pediatrics and Child Health, University of Western Australia, Perth, Western Australia, Australia. harveyc@cyllene.uwa.edu.au
Abstract:
Until recently the only available antibiotic eardrops for treatment of the discharging middle ear and mastoid cavity have been potentially ototoxic. With the advent of non-ototoxic fluoroquinolone eardrops, consensus panels in the USA, Canada and the UK have advocated the preferential use of these agents in the open middle ear. However, in Australia, no fluoroquinolone topical agent is approved for use with tympanic membrane perforations, and when used as an 'off label' eardrop, none is on the Pharmaceutical Benefits Scheme. This creates an ethical dilemma, particularly with best practice management of chronic suppurative otitis media in indigenous children. Despite concerns regarding resistance issues with ototopical use of systemic antibiotics, bacterial resistance has not been documented in major studies. For equity and ethical reasons, Australian regulatory authorities should consider approving a sterile non-ototoxic eardrop for use in the open middle ear.
Insights
Non-ototoxic antibiotic eardrops are recommended for open middle ear infections. However, Australia lacks approval for these, creating ethical issues, especially for Indigenous children with chronic suppurative otitis media.
Area of Science:
- Otolaryngology
- Infectious Diseases
- Pharmacology
Background:
- Historically, antibiotic eardrops for middle ear infections were ototoxic.
- Non-ototoxic fluoroquinolone eardrops are now available and recommended internationally.
Purpose of the Study:
- To address the ethical dilemma of using non-ototoxic eardrops in Australia.
- To advocate for regulatory approval of fluoroquinolone eardrops for tympanic membrane perforations.
Main Methods:
- Review of current international guidelines and Australian regulatory status.
- Analysis of ethical considerations in managing chronic suppurative otitis media.
Main Results:
- International consensus supports non-ototoxic fluoroquinolones for open middle ear.
- Australia has no approved fluoroquinolone eardrops for perforated eardrums.
- Off-label use is not subsidized, posing access barriers.
Conclusions:
- Australian regulatory authorities should approve sterile, non-ototoxic eardrops.
- Approval is crucial for equitable and ethical management of chronic suppurative otitis media, particularly in Indigenous children.
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