Simcor and Hepatotoxicity

The use of nicotinic acid and its derivatives at dosages substantially exceeding those for physiologic requirements is contraindicated in patients with active liver disease or unexplained, persistent elevations of serum transaminases. Hepatotoxicity, including biochemical abnormalities of liver function, cholestatic jaundice, increased prothrombin time, and fulminant hepatic necrosis and failure, has been reported during therapy with niacin and niacinamide (nicotinamide), particularly in patients who have substituted sustained-release nicotinic acid products for immediate-release preparations at equivalent dosages. Treatment using pharmacologic dosages (e.g., lipid-lowering dosages) of these agents should be administered cautiously in patients with gallbladder disease or a history of jaundice, liver disease and/or heavy alcohol use. Liver transaminase levels should be evaluated prior to initiation of therapy, every 6 to 12 weeks for the first year, and periodically thereafter (e.g., semiannually). Patients who develop elevated ALT or AST levels during therapy should be monitored until abnormalities resolve. If an increase above 3 times the upper limit of normal persists, therapy should be withdrawn. Liver biopsy should be considered in patients with elevations that persist beyond cessation of therapy.