Methods: case report.
Results: A 52-old-year male patient was taking Gentamicin (INN: gentamicin) 80 mg/24 hours on four days between 2011-Aug-27 and 2011-Sep-03 for an infection of arterio-venous fistula. Two weeks after drug administration he developed an instability while walking, headache, feeling of discomfort in the head. The outcome of the events was unknown. Concomitant medication was Ferrlecit (INN: sodium feric gluconate), Ranisan (INN: ranitidine), Monopril (INN: fosinopril), Carvilex (INN: carvedilol) and epoetin. The patient was on chronic dialysis treatment.
Lab. examination:
CT scan of the brain: normal findings.
x-ray of the cervical spine: initial signs of spondylosis.
ORL audiometry: severe bilateral damage of vestibular sense and hearing damage on high frequences.
The events were assessed as medical important by the company.
Conclusions: This case was classified as serious. The causal relationship between gentamicin and the suspected adverese reaction was assessed as possibly related based on the temporal association and the known safety profile, .which includes ototoxicity, damages to the eighth cranial nerve (vestibular and auditory) and vertigo. Headache and gait instability are not explicitly listed, the other suspected adverse reactions are listed according to the current Reference Safety Information (RSI).
Headache and gait instability can be seen as consequence of the nerve damage by gentamicin. For the gait disturbance the preexisting spondylosis of the cervical spine provides an alternative plausible explanation.
This case does not change the overall benefit-risk balance of the medicinal product.