Aventis Pharmaceuticals and FDA
Aventis Pharmaceuticals and FDA updated the prescribing information for Arava (leflunomide), indicated for the treatment of active rheumatoid arthritis. In postmarketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during treatment with Arava. Most cases occurred within 6 months of therapy and in a setting of multiple risk factors for hepatotoxicity. Rare postmarketing reports of severe infections, including sepsis, which may be fatal, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy and/or comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.
To read the MedWatch 2003 safety summary, including links to the "Dear Healthcare Professional" letter and the revised label: