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Gentamicin nephrotoxicity: Animal experimental correlate with human pharmacovigilance outcome

Olufunsho Awodele1, Oyindamola P Tomoye, Neils B Quashie

  • 1Department of Pharmacology, College of Medicine, Idi-Araba, University of Lagos, Nigeria.

Biomedical Journal
|September 3, 2014
PubMed
Abstract

Insights

Gentamicin toxicity in the kidneys depends on dose and duration. High-dose gentamicin (280 mg) administration showed significant kidney damage, supporting its ban in Nigeria.

Area of Science:

  • Pharmacology
  • Toxicology
  • Nephrology

Background:

  • The National Agency for Food and Drugs Administration and Control (NAFDAC) in Nigeria withdrew injection gentamicin 280 mg due to toxicity concerns.
  • Gentamicin is crucial for treating life-threatening and multidrug-resistant infections.

Purpose of the Study:

  • To investigate the kidney toxicity profile of commonly used gentamicin strengths (80 mg and 280 mg).
  • To evaluate the impact of different doses and durations of gentamicin administration on renal function in animal models.

Main Methods:

  • Rats were divided into five groups, receiving varying doses (1.14 mg/kg, 4 mg/kg) and durations (7, 14 days) of gentamicin or distilled water (control).
  • Kidney histopathology, serum creatinine levels, and antioxidant enzyme activities were assessed.
  • Reversibility of toxicity was studied over 7 and 14 days post-treatment.

Main Results:

  • A significant increase in creatinine levels was observed in rats receiving 4.0 mg/kg gentamicin for 14 days.
  • Elevated lipid peroxidation and acute tubular necrosis were noted in most gentamicin-treated groups.
  • Kidney damage was dose- and duration-dependent.

Conclusions:

  • Gentamicin's kidney toxicity is directly related to the administered dose and treatment duration.
  • The study findings validate NAFDAC's decision to ban high-dose (280 mg) gentamicin injections in Nigeria.
  • This research highlights the importance of pharmacovigilance in drug safety.

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