Safety assessment of vitacoxib: 180-day chronic oral toxicity studies

Regul Toxicol Pharmacol. 2018 Jun:95:244-249. doi: 10.1016/j.yrtph.2018.03.024. Epub 2018 Mar 27.

Abstract

Vitacoxib, a selective COX-2 inhibitor, is approved for the relief of pain and inflammation associated with orthopedic surgery and osteoarthritis in dogs. In the current study, a chronic toxicity research was performed to evaluate the safety of vitacoxib in male and female rats for long-term. Vitacoxib was dosed orally to groups of rats for 180 days at 1.2, 6, 30 mg/kg bw/day by gavage. The chronic study oral administration of vitacoxib did not show observational or toxicological effects on the body or organ weights, food consumption, hematology and biochemistry at dose 6 mg/kg bw. However, vitacoxib (30 mg/kg) showed minor alterations to histopathology of liver, kidney and stomach related to treatment. These results provide further indication that vitacoxib is safe and well-tolerated in rats after 180 days of daily oral administration at 6 mg/kg bw and the NOAEL for both sexes was 6 mg/kg bw for 180 consecutive days.

Keywords: Coxibs; NSAIDs; Safety evaluation; Toxicity studies; Vitacoxib.

MeSH terms

  • Administration, Oral
  • Animals
  • Cyclooxygenase 2 Inhibitors / toxicity*
  • Female
  • Imidazoles / toxicity*
  • Kidney / drug effects
  • Kidney / pathology
  • Liver / drug effects
  • Liver / pathology
  • Male
  • No-Observed-Adverse-Effect Level
  • Rats, Sprague-Dawley
  • Stomach / drug effects
  • Stomach / pathology
  • Sulfones / toxicity*
  • Toxicity Tests, Chronic

Substances

  • Cyclooxygenase 2 Inhibitors
  • Imidazoles
  • Sulfones
  • vitacoxib