Subacute study on the effects of Off-Label use of Tramadol-Lacasera® combination on Biochemical Parameters: Effects on Electrolytes, Kidney, and Liver Function Parameters in Humans using Wistar rats

Abstract

Tramadol misuse, particularly for off-label purposes, has become a major aspect of the broader substance use challenge in recent years, and it is rapidly evolving into a health crisis. Tramadol is used off-label among young men in Nigeria, Asia, and other African countries for premature ejaculation, euphoria, and sustained painless physical activities. To conceal the bitter taste of Tramadol and promote euphoria, abusers always dissolve it with Lacasera® soft drink. To investigate the possible effects of this combination in humans, a 28-day subacute toxicity study was conducted with male Wistar rats. The rats were divided into eight groups (six per group). Group 1 received Lacasera® soft drink while group 2 received deionized water. Groups 3, 4 and 5 received 35mg/kg/day, 70.7mg/kg/day and 106mg/kg/day of Tramadol dissolved in deionized water, respectively. Groups 6, 7 and 8 received similar doses of Tramadol dissolved in Lacasera® soft drink. Blood samples were collected from the rats and analyzed using standard methods. Results were presented as mean ± SD and p≤0.05 values were considered statistically significant. The electrolytes results indicated statistically significant dose-dependent increase in Na and Clions, but decreased significantly in K+ and HCO3- in the groups treated with Lacasera®-Tramadol combination. In the Lacasera®-Tramadol combination, urea and creatinine increased dose-dependently. The AST, ALT, ALB, TB, and CB in the Lacasera®-Tramadol combination showed dose-dependent significant increase in these liver function parameters. Our studies show that even at a standard dose, Lacasera® soft drink renders Tramadol more toxic. Chronic abuse of this combination increases the risk of major health problems such electrolyte imbalance, which can lead to hypertension, liver dysfunction, and renal failure.