Leflunomide: hepatic reactions.

European Union -- The Committee for Proprietary Medicinal Products (CPMP) of the European Agency for the Evaluation of Medicines (EMEA) has evaluated reports of serious liver injuries, including hepatitis, hepatic failure and rare cases of acute hepatic necrosis, some with fatal outcome, in patients treated with leflunomide (Arava[R]). Leflunomide is a disease-modifying antirheumatic drug which inhibits the enzme dihydro-orotate dehydrogenase and exhibits antiproliferative activity.

Prescribers are reminded that leflunomide should only be prescribed by specialists experienced in the treatment of rheumatoid diseases. The EMEA wishes to draw attention to the following …