[Off-label use in long-term anticoagulation after liver transplantation due to phenprocoumon-induced hepatic failure]

Drug therapy should be individualized according to criteria of efficacy, adverse effects, and treatment adherence. This is particularly important at the interface of inpatient and ambulatory care. Aspects of drug approval (labeling) and individual refunding by health care insurance should also be taken into account.

A patient (male, 61 years, painter) showed elevated transaminases after treatment with phenprocoumon because of a deep vein thrombosis in 1999. Transaminases normalized completely after discontinuation of phenprocoumon. Other reasons for the elevated transaminases could be excluded. After a recurrent thrombosis in 2003 phenprocoumon was prescribed again followed by recurrent elevation of transaminases and subsequent cholestatic hepatitis progressing to fulminant hepatic failure that required liver transplantation. After transplantation the patient's general state of health was good and liver function nearly normal. Anticoagulation was indicated beyond the postoperative phase because of recurrent deep vein thrombosis and atrial fibrillation. A low-molecular-weight heparin was chosen for long-term treatment.

A low-molecular-weight heparin appears to be the most appropriate way to maintain effective and safe anticoagulation in this patient. Coumarins carry a residual risk of an extrahepatic, immunologically mediated cross-sensitization. Long-term use of ximelagatran may also cause liver damage. For heparinoids, hirudins, and other drugs affecting coagulation like platelet aggregation inhibitors, therapeutic evidence is not sufficient. Though subcutaneous application of heparin is a disadvantage for the patient, therapeutic alternatives do not have better documented efficacy or less hepatotoxic potential. The low-molecular-weight heparin fulfills the criteria for refunding set by federal jurisdiction.