FDA Advisory Panel Finds Leflunomides Safety is Adequate
In response to concerns over the rheumatoid arthritis (RA) drug leflunomide (Arava®), the FDA appointed an advisory panel of experts to review data and determine if the safety risks of leflunomide were acceptable. In a 20-0 vote, the panel has agreed that leflunomides safety is adequate and acceptable. Based on evidence to date, the panel believes that the benefits of leflunomide outweigh the potential safety risks. Additionally, the panel supports the approval of a new indication for leflunomide, that being the improvement physical function in patients with RA.