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Ototoxic ear drops with grommet and tympanic membrane perforations: a position statement

Robert J Black, Vince C Cousins, Peter Chapman, Zoran Becvarovski, Harvey L C Coates, Stephen J O’Leary, Christopher F Perry and Brian J Williams
MJA 2007; 186 (11): 605-606

To the Editor: Systemic ototoxicity secondary to the use of aminoglycosides is well known in clinical medicine, and appropriate monitoring measures to prevent vestibulo-cochlear ototoxicity are routinely performed. Less well known is the potential for topical ear drops, particularly the aminoglycoside group, to cause both vestibular and cochlear damage when introduced through a patent grommet or tympanic membrane perforation for the treatment of infection.1 Although the incidence of aminoglycoside ototoxicity with ear drops is uncommon (for cochlear toxicity, in the order of one in 10 000 patients treated2), individual susceptibility and patient compliance problems may lead to inner ear damage.

Concerns with the potential ototoxicity of aminoglycoside ear drops has led to American,3 British4 and Canadian5 expert committees providing guidelines on the use of potentially ototoxic ear drops in patients with tympanic membrane perforations or patent grommets. The Consensus Panel of the Australian Society of Otolaryngology Head and Neck Surgery (ASOHNS) unanimously agreed on the recommendations shown in the Box, which are based on the American guidelines.

Broadly speaking, the Consensus Panel recommends avoiding the use of ototoxic ear drops in patients with perforated tympanic membranes where possible.

The Australian National Aboriginal Community Controlled Health Organisation study showed that the non-ototoxic fluoroquinolone drops were more effective than commonly used ototoxic ear drops.1 An application to the Therapeutic Goods Administration for introduction of ciprofloxacin drops to the ear has recently been approved, and has been placed on the Pharmaceutical Benefits Scheme as an authority prescription for Aboriginal and Torres Strait Islander children with chronic suppurative otitis media as of February 2007.

However, clinical circumstance may dictate that potentially ototoxic agents need to be used if culture/sensitivity testing suggests that fluoroquinolone drops would not be appropriate, are unavailable, or if previous treatment with fluoroquinolone ear drops failed.

The Consensus Panel did not believe routine auditory/vestibular monitoring was warranted by the risks of ototoxicity, provided the treatment was short (5–10 days).

The full document outlining the Consensus Panel’s recommendations is available from ASOHNS.

Recommendations of the Consensus Panel of the Australian Society of Otolaryngology Head and Neck Surgery on ototoxic ear drops and tympanic membrane perforation

  • Non-ototoxic eardrops are preferable in the presence of tympanic membrane perforations or grommets.

  • If potentially ototoxic antibiotic ear drops are used, they should only be used in infected ears and discontinued immediately the infection has resolved.

  • If potentially ototoxic antibiotic ear drops are prescribed for use in the open middle ear or mastoid, the reason for their use and a warning to the patient/parent of the risk of ototoxicity should be given and documented.

  • If potentially ototoxic antibiotics are prescribed, the patient should be specifically instructed to return to the doctor if he or she develops vertigo, hearing loss or tinnitus.

  • If the tympanic membrane is known to be intact and the middle ear and mastoid are closed, then the use of potentially ototoxic preparations presents no risk of ototoxic injury.

Competing interests: Zoran Becvarovski, Harvey Coates, and Christopher Perry received honoraria for attendance at scientific meetings sponsored by Alcon Laboratories, which maufactures ciprofloxacin ear drops.

Robert J Black, President1 and Associate Professor2Vince C Cousins, Immediate Past-President1Peter Chapman, Chairman, Pharmaceutical Sub-Committee1Zoran Becvarovski, Surgeon1Harvey L C Coates, Clinical Associate Professor and Senior Ear, Nose and Throat Surgeon3Stephen J O’Leary, Otolaryngologist4Christopher F Perry, Associate Professor2 and Otolaryngology/Head and Neck Surgeon5,6Brian J Williams, Ear, Nose and Throat Specialist7

1 Australian Society of Otolaryngology Head and Neck Surgery, Sydney, NSW.

2 University of Queensland, Brisbane, QLD.

3 University of Western Australia, Perth, WA.

4 Royal Victorian Eye and Ear Hospital, Melbourne, VIC.

5 Royal Children’s Hospital, Brisbane, QLD.

6 Princess Alexandra Hospital, Brisbane, QLD.

7 Sydney, NSW.

presidentATasohns.org.au

  1. Couzos S, Lea T, Mueller R, et al. Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: a community based, multicentre, double-blind randomised controlled trial. Med J Aust 2003; 179: 185-190. <eMJA full text> <PubMed>
  2. Roland PS. Clinical ototoxicity of topical antibiotic drops. Otolaryngol Head Neck Surg 1994; 110: 598-602. <PubMed>
  3. American Academy of Otolaryngology — Head and Neck Surgery. Efficacy and safety of topical antibiotics in the treatment of ear disease: consensus panel update 2004. Otolaryngol—Head Neck Surg 2004; 130: S51-S94.
  4. Committee on Safety of Medicines. Reminder: ototoxicity with aminoglycoside eardrops. Curr Prob Pharmacovigilance 1997; 23: 14.
  5. Pilla NJ, Rosser WW, Pennie RA, and the Anti-Infective Review Panel. Anti-infective guidelines for community acquired infections. Toronto: MUMS Guidelines Clearinghouse, 2001: 15.

(Received 13 Dec 2006, accepted 7 Mar 2007)

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