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

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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… Click to show full abstract

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. HighlightsThe chronic oral toxicity of viacoxib in rats was firstly assessed.Significant pathological alterations were noted in kidneys, liver and stomach in 30 mg/kg bw groups in 135‐day and 180‐day.The NOAEL for chronic toxicity of vitacoxib was 6 mg/kg bw/day for rats when administered orally for 180‐day.

Keywords: chronic oral; vitacoxib; 180 day; toxicity; day; oral toxicity

Journal Title: Regulatory Toxicology and Pharmacology
Year Published: 2018

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