The prescription arthritis drug Arava, produced by Aventis and also known as leflunomide, has been used since 1998 to treat rheumatoid arthritis. The drug has been blamed for a high number of cases of severe liver problems and deaths. Consumer groups warn that the public is largely unaware of the serious and life-threatening complications potentially associated with use of Arava, and are asking that the drug be removed from the market.

In the past few years, Arava has been identified in numerous deaths and severe liver reactions. According to the United States Food and Drug Administration (FDA), Arava has been linked to approximately 130 cases of severe liver toxicity, 56 hospitilizations, and at least 12 deaths.

Various reports suggest that Avara is more fatal than the equally or more effective drug, methotrexate. According to one report, Arava was linked to six times more cases of fatal liver toxicity and 13 times more reports of hypertension than methotrexate, despite the fact that there were 6.8 million more prescriptions filled for methotrexate than Arava during that time.

Reports have also linked the drug to the life threatening autoimmune disease, Stevens-Johnson syndrome, whereas methotrexate has not. Yet another concern is that the drug could cause serious problems even after the patient discontinues use because drug byproducts can remain in body for months.

Dr. David Yocum of the Arizona Arthritis Center, who was recently chair of the FDA's Arthritis Drugs Advisory Committee, agreed Arava should be removed from the market. Yocum reported to the FDA a death of one of his patients from acute liver failure after using Arava. The European Agency for Evaluation of Medicinal Products has issued an urgent warning about the drugs' toxicity.

Arava side-effects include liver problems (elevated liver enzymes, yellowing of skin, blood in urine, etc.), hypertension (shortness of breath), blood disorders, high blood pressure, severe diarrhea and Stevens-Johnson syndrome.