Prograf Linked To Cardiotoxicity?

Fujisawa's new immunosuppressant drug Prograf (tacrolimus) has been linked to five cases of cardiotoxicity in pediatric patients, according to Canadian researchers writing in The Lancet (April 8).

The researchers describe five consecutive transplant patients (three small bowel with or without liver and two liver transplant patients) who were treated with tacrolimus. Two developed congestive heart failure and hypertrophic obstructive cardiomyopathy which resolved after changing to ciclosporin (Sandoz' Neoral), while in the other three patients the cardiomyopathy regressed or improved with a lower dose of tacrolimus or after stopping the drug.

The most compelling evidence for a cardiotoxic effect of tacrolimus came from one of the five patients, who developed concentric hypertrophic cardiomyopathy which regressed after the drug was discontinued and restarted within two months after restarting the treatment. The researchers suggest that CHC may be more of a problem in small bowel transplant patients, where higher doses of immunosuppressants are required, and recommend that children should be monitored while on the drug. "Fortunately, these effects of tacrolimus seem to be at least partly reversible in most patients," they conclude.