Arava, generically known as lenflunomide, is an anti-inflammatory drug used for the treatment of rheumatoid arthritis. Patients with rheumatoid arthritis (RA) take Arava to reduce the pain and swelling that occurs in joints, most notably in the hands or feet. Aventis, the maker of the drug, reports that there have been 1.5 million prescriptions written for Arava since 1998.
On March 28, 2002, the consumer watchdog group, Public Citizen, declared Arava a seriously dangerous drug. In an urgent announcement, the organization demanded the FDA immediately recall Arava for the severe side effects and deaths reported in patients taking the drug since its approval in 1998.
According to the Public Citizen, there have been 12 reported deaths, 56 hospitalizations and 130 cases of severe liver toxicity associated with Arava between September 1998 and September 2001. Two of the twelve Arava-related deaths reported were people in their 20's. In addition, Arava has been linked to twelve cases of the autoimmune disease Stevens-Johnson Syndrome with symptoms of an extreme allergic reaction. With such devastating injuries over such a short amount of time, the Public Citizen and its chief supporter Dr. David Yocum, previously of the FDA's Arthritis Drugs Advisory Committee, have petitioned the FDA to recall Arava.
Symptoms and side effects of Arava include severe liver
damage, elevated liver enzymes, lymphoma, blood disorders, high
blood pressure, severe diarrhea, Stevens-Johnson Syndrome and
death.
Arava is not the only prescription available to patients with
rheumatoid arthritis. Arava was tested less than or equally effective
to an older RA treatment on the market, methotrexate. In fact,
methotrexate, although prescribed 5.5 times more often than Arava,
has less than 6 times the amount of cases of liver toxicity and 13
times fewer reports of hypertension. With a safer alternative, the
risks of Arava outweigh its benefits.
