Aminoglycoside antibiotics MHRA drug safety update

Aminoglycosides (gentamicin, amikacin, tobramycin, and neomycin): increased risk of deafness in patients with mitochondrial mutations

MHRA drug safety update January 2021

Evidence suggests an increased risk of aminoglycoside-associated ototoxicity in patients with certain mitochondrial mutations (particularly the m.1555A>G mutation), including cases in which the patient’s aminoglycoside serum levels were within the recommended range. These mitochondrial mutations are rare and frequency of complication is uncertain.

Genetic testing should not delay urgently needed aminoglycoside treatment but consider the need for genetic testing, particularly in those requiring recurrent or long-term treatment with aminoglycosides.

Where the patient has a susceptible mutation consider the need for aminoglycoside treatment versus alternative options.

To minimise the risks of adverse events, including ototoxicity, monitor in all patients:

• Renal function (serum creatinine, creatinine clearance) before, during and after treatment
• Hepatic function before, during and after treatment
• If treatment is longer than 2 weeks, auditory testing at beginning and end of treatment. Test sooner if patient develops symptoms of deafness or vestibular dysfunction develops.
• Patients should be advised to report immediately the onset of any sign of deafness or vestibular dysfunction.