What is the difference between Arava® and competitor methotrexate to treat rheumatoid arthritis?
When the FDA first approved Arava®, the agency noted it worked no better than methotrexate, but it provided more options to patients. Sidney Wolfe, director of the consumer advocacy group Public Citizen, compared the two arthritis drugs and found the FDA has six times more reports of liver damage with Arava® patients than methotrexate patients. Wolfe also noted that FDA records show more reports of lymphoma, high blood pressure, and a life-threatening autoimmune disorder Stevens-Johnson syndrome in Arava® patients than methotrexate patients. There have been 6.8 million more prescriptions filled for methotrexate than Arava®, but still the number of adverse effects remains higher in lenflunomide users. The death rate in Arava® users is 33 times higher, according to Wolfe.