Arava

Aventis Pharmaceuticals and FDA updated the prescribing information for Arava (leflunomide), indicated for the treatment of active rheumatoid arthritis. In post marketing experience worldwide, rare, serious hepatic injury, including cases with fatal outcome, have been reported during the treatment with Arava. Most cases occurred within six months of therapy and in a setting of multiple risk factors for hepatoxicity. Rare post marketing reports of severe infections, including sepsis, which may be fatal, were also received. Most of the reports were confounded by concomitant immunosuppressant therapy comorbid illness, which, in addition to rheumatoid disease, may predispose patients to infection.

So far, there have been at least 130 cases of severe liver problems (hepatoxicity) and 22 deaths since Arava's arrival to the market in 1998. Arava side effects can result in continued instances of death and serious health conditions that may have been prevented.

• MedWatch - 2003 Safety Information Alerts