United States of America. The Food and Drug Administration has approved leflunomide (Arava: Hoechst Marion Roussel, tablets 10mg, 20 mg and 100 mg), the first oral treatment for slowing progression of active rheumatoid arthritis.
Although leflunomide does not cure rheumatoid arthritis, it has been shown in clinical trials to provide relief for painful, swollen joints caused by this disease and to retard damage to joints.
Because animal studies raised concerns that leflunomide can cause birth defects, a special warning is included in the labelling stating that leflunomide should never be used by pregnant women or women of childbearing age who are not using reliable contraception. Because the drug persists in the body for a long time, a drug elimination procedure is recommended for patients who want to become pregnant after taking leflunomide.
Adverse effects include risk of liver toxicity, diarrhoea, hair loss and rash. Physicians should monitor liver enzymes of patients taking leflunomide according to guidance in the labelling. Leflunomide is not recommended in patients with significant liver disease.
References: FDA Talk Paper T98-54 dated 11 September 1998.