Unpredictability of flecainide plasma concentrations in patients with renal failure: relationship to side effects and sudden death?

We report a retrospective evaluation of plasma concentrations of flecainide obtained from five dialysis patients during chronic oral treatment. A more than sevenfold variation in the dose/concentration relationship was observed. Plasma concentrations of flecainide above 1,200 ng/ml appeared to be associated with serious side effects and in one case with sudden death. Therefore, flecainide should be used with extreme caution in patients with impaired renal function. Frequent therapeutic drug monitoring should be mandatory.